A Phase 3 interventional study of ITM + Sham QLB and ITM + Bupivacaine QLB in Pain, Postoperative, sponsored by Nicholas Schott. Terminated at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-05-06.
Sponsored by Nicholas Schott · Phase 3, Interventional, and Treatment
Among 362 studies testing bupivacaine in Pain, Postoperative — 55 open to participants now, 58 under way, 5 of them phase 3. Bupivacaine · Pain, Postoperative.
Among the 362 studies testing bupivacaine in Pain, Postoperative, this one is the 323rd largest by enrollment, is one of 31 that started in 2017, is one of 42 in phase 3, and was the 120th registered.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's enrollment of 21 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →55 of the 362 studies testing bupivacaine in Pain, Postoperative are open now, in 8 countries. Each count lists the studies.
Bupivacaine: first FDA approval 1972 (MARCAINE HYDROCHLORIDE PRESERVATIVE FREE), first EMA approval 2020. What it is approved for, and how studies give it, is on its page →
Of the 679 Pain, Postoperative studies recruiting now, 241 (35%) set no upper age limit and 328 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.
This study: 18 Years to 45 Years · female · no healthy volunteers.
The full table on the hub →362 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 31 started in 2017.
Median enrollment 70 across the 362 interventional studies. Of the 258 that completed or were terminated, 106 (41%) have results posted.
46 of 362 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Nicholas Schott as lead sponsor.
Nicholas Schott has 1 study filed under Pain, Postoperative — fewer than ten, so there is no comparison to draw.
21 of the studies testing bupivacaine in Pain, Postoperative that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06350981Phase 3Foundation for Orthopaedic Research and EducationAnalgesic Requirement for Post-Operative Pain Control in TLIP Interbody Fusion | 2027-01-01 |
| NCT06077422Phase 3Rutgers, The State University of New JerseyExparel vs. Marcaine ESP Block for Post-cardiac Surgical Pain | 2027-01-11 |
| NCT07650760Wah Medical college , POF hospitalComparison of Intraperitoneal Bupivacaine and Saline Irrigation for Pain Relief After Laparoscopic Cholecystectomy | 2026-12 |
| NCT03737292Milton S. Hershey Medical CenterLiposomal Bupivacaine Versus Plain Bupivacaine After Intercostal Injections For Pain Management After Thoracoscopy | 2026-12 |
| NCT02381353Mayo ClinicExparel Injection for Postoperative Orbital Pain | 2026-12 |
Among the 362 studies testing bupivacaine in Pain, Postoperative, from their registry updates:
Comparison of standard post-operative cesarean surgery pain management with regional post-op pain control.
The purpose of this trial is to determine the efficacy of a postoperative analgesia strategy that incorporates quadratus lumborum block (QLB) in conjunction with a multi-modal post-cesarean analgesia strategy. The investigators hypothesize that QLB will provide superior post-cesarean analgesia compared to the current standard of care, multi-modal analgesia.
Thus, analgesia following cesarean section using QLB compared to the current standard of care alone will be further investigated. Current practice for cesarean surgical intervention consists of multi-modal analgesia (i.e., Intrathecal morphine (ITM) and scheduled post-operative non-opioid oral analgesics, with oral opioid analgesics reserved for breakthrough pain).
Investigators will measure side-effects associated with each strategy: Standard of care methods consisting of intrathecal morphine (ITM) plus scheduled non-opioid analgesics in conjunction with prn opioid analgesics for breakthrough pain will be utilized for both. The experimental treatment arm will entail standard of care in addition to QLB. The sham comparator will entail standard of care in addition to QLB with saline.
For each strategy, we will measure and model associated economic ramifications; such factors will include drug costs, procedure costs, and costs associated with length of stay and re-admissions.
The quadratus lumborum block (QLB) is similar to the transversus abdominis plane (TAP) block, but differs slightly in regards to the anatomical region where local anesthetic is injected. Since the quadratus lumborum (QL) is more posteriorly located, it theoretically confers greater safety due to enhanced visualization. The TAP block has been studied extensively for post-cesarean delivery pain, consistently showing that it is not superior to ITM for post-operative analgesia; however, it may prove to be helpful in patients with breakthrough pain despite the use of ITM, or in patients who were unable to receive ITM (e.g. general anesthesia for cesarean, contraindications to neuraxial morphine). Thus, ITM is superior to TAP alone for post-cesarean analgesia, but it is associated with a dose-dependent increased risk for opioid related side effects. In 2015, Blanco et. al. published a study specifically using the QLB for postoperative pain after cesarean delivery. In this study, they compared a true QLB to a sham QLB all in patients who did not receive ITM, and found that the QLB provided improved pain control and decreased the need for post-operative opioids. Another study in 2016 demonstrated that the QLB is superior to the TAP block in regards to decreasing post-operative pain following c-section. Unfortunately, neither study compared the QLB to ITM (part of the current gold standard for post-cesarean delivery pain, multimodal analgesia).
The gap in knowledge regarding the utility of QLB as part of a multimodal analgesic approach including ITM for cesarean section warrants further investigation. Clinicians are constantly searching for methods to provide patients with the most effective medical interventions that provide maximal benefit and minimal harm. Post-operative pain control following cesarean delivery is an area that is important to patients and to providers, and the introduction of the QLB for this purpose has the potential to improve analgesic benefit.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.
Drug: ITM + Sham QLB
Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.
Drug: ITM + Bupivacaine QLB
Sham subcutaneous non-anesthetic infiltration with saline
Also known as: Saline
Drug page: Bupivacaine
QL plane block with local anesthesia
Also known as: Bupivacaine
Visual Analogue Scale (VAS) Pain Score With Movement
Post-operative pain accompanied with patient movement will be measured using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.
Time frame: 24 hours after surgical procedure (cesarean delivery)
Breast Feeding Success/Quality
Limited breastfeeding resulting from pain or opioid side effects
Time frame: 24-hours post-operatively
Visual Analogue Scale (VAS) Pain Score at Rest
VAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.
Time frame: 1 hour after intervention
First Request for Pain Medication
Time to first opioid dose (measured in hours)
Time frame: From post-operative until the patient is either withdrawn from the study or requests analgesic medication up until 72 hours
Sedation
Presence or absence will be noted. Will be measured via Ramsay Sedation Score which ranges on a scale of 1 to 6 as follows: 1-patient is anxious, agitated, or restless. 2-patient is co-operative and oriented. 3-patient responds to commands only. 4-patient exhibits brisk response to light stimuli or loud auditory stimuli. 5-patient exhibits sluggish response to light or auditory stimuli. 6-patient exhibits no response.
Time frame: 24-hours post-operative
Pruritis
Presence or absence will be noted via standard pruritus scale (0-3). 0 being no evidence of pruritus, group 1 being pruritus on diseased skin, group 2 being pruritus on non-diseased skin, and group 3 being chronic reactive lesions acquired from skin manipulation, such as rubbing, picking, or scratching
Time frame: 4-hours post-operative
Nausea/Vomiting
Presence or absence will be noted via a scale of 0-3 as follows: 0-no nausea, 1-mild nausea not requesting pharmacological rescue, 2-moderate nausea requesting pharmacological rescue, and 3-severe nausea resistant to pharmacological treatment
Time frame: 4-hours post-operative
Systolic Blood Pressure
Will be measured in mmHG per standard of care and documented by study staff.
Time frame: 4-hours post-operative
Respiratory Rate
Will be measured in rate/min per standard of care and documented by study staff
Time frame: 4-hours post-operative
Oxygen Saturation
Will be measured in % per standard of care and documented by study staff
Time frame: 4-hours post-operative
Visual Analogue Scale (VAS) Pain Score at Rest
VAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.
Time frame: 4 hours after intervention
Visual Analogue Scale (VAS) Pain Score at Rest
VAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.
Time frame: 24 hours after intervention
Visual Analogue Scale (VAS) Pain Score at Rest
VAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.
Time frame: 48 hours after intervention
Pruritis
Presence or absence will be noted via standard pruritus scale (0-3). 0 being no evidence of pruritus, group 1 being pruritus on diseased skin, group 2 being pruritus on non-diseased skin, and group 3 being chronic reactive lesions acquired from skin manipulation, such as rubbing, picking, or scratching
Time frame: 24-hours post-operative
Pruritis
Presence or absence will be noted via standard pruritus scale (0-3). 0 being no evidence of pruritus, group 1 being pruritus on diseased skin, group 2 being pruritus on non-diseased skin, and group 3 being chronic reactive lesions acquired from skin manipulation, such as rubbing, picking, or scratching
Time frame: 48-hours post-operative
Nausea/Vomiting
Presence or absence will be noted via a scale of 0-3 as follows: 0-no nausea, 1-mild nausea not requesting pharmacological rescue, 2-moderate nausea requesting pharmacological rescue, and 3-severe nausea resistant to pharmacological treatment
Time frame: 24-hours post-operative
Nausea/Vomiting
Presence or absence will be noted via a scale of 0-3 as follows: 0-no nausea, 1-mild nausea not requesting pharmacological rescue, 2-moderate nausea requesting pharmacological rescue, and 3-severe nausea resistant to pharmacological treatment
Time frame: 48-hours post-operative
Heart Rate
Standard heart rate obtained
Time frame: 4-hours post-operative
Heart Rate
Standard heart rate obtained
Time frame: 24-hours post-operative
Heart Rate
Standard heart rate obtained
Time frame: 48-hours post-operative
Systolic Blood Pressure
Will be measured in mmHG per standard of care and documented by study staff.
Time frame: 24-hours post-operative
Systolic Blood Pressure
Will be measured in mmHG per standard of care and documented by study staff.
Time frame: 48-hours post-operative
Diastolic Blood Pressure
Will be measured in mmHG per standard of care and documented by study staff.
Time frame: 4-hours post-operative
Diastolic Blood Pressure
Will be measured in mmHG per standard of care and documented by study staff.
Time frame: 24-hours post-operative
Diastolic Blood Pressure
Will be measured in mmHG per standard of care and documented by study staff.
Time frame: 48-hours post-operative
Respiratory Rate
Will be measured in rate/min per standard of care and documented by study staff
Time frame: 24-hours post-operative
Respiratory Rate
Will be measured in rate/min per standard of care and documented by study staff
Time frame: 48-hours post-operative
| Milestone | ITM + Sham QLB | ITM + Bupivacaine QLB |
|---|---|---|
| Started | 10 | 11 |
| Completed | 10 | 11 |
| Not completed | 0 | 0 |
Post-operative pain accompanied with patient movement will be measured using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.
| Units on a scale | ITM + Sham QLB | ITM + Bupivacaine QLB |
|---|---|---|
| Visual Analogue Scale (VAS) Pain Score With Movement | 4.85 ± 2.23 | 3.14 ± 1.83 |
Limited breastfeeding resulting from pain or opioid side effects
No measurements were reported for this outcome.
VAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.
No measurements were reported for this outcome.
Time to first opioid dose (measured in hours)
| Hours | ITM + Sham QLB | ITM + Bupivacaine QLB |
|---|---|---|
| First Request for Pain Medication | 17.30 ± 14.90 | 17.37 ± 14.29 |
Presence or absence will be noted. Will be measured via Ramsay Sedation Score which ranges on a scale of 1 to 6 as follows: 1-patient is anxious, agitated, or restless. 2-patient is co-operative and oriented. 3-patient responds to commands only. 4-patient exhibits brisk response to light stimuli or loud auditory stimuli. 5-patient exhibits sluggish response to light or auditory stimuli. 6-patient exhibits no response.
| Participants | ITM + Sham QLB | ITM + Bupivacaine QLB |
|---|---|---|
| Score 1 | 0 | 0 |
| Score 2 | 10 | 11 |
| Score 3 | 0 | 0 |
| Score 4 | 0 | 0 |
| Score 5 | 0 | 0 |
| Score 6 | 0 | 0 |
Presence or absence will be noted via standard pruritus scale (0-3). 0 being no evidence of pruritus, group 1 being pruritus on diseased skin, group 2 being pruritus on non-diseased skin, and group 3 being chronic reactive lesions acquired from skin manipulation, such as rubbing, picking, or scratching
| Participants | ITM + Sham QLB | ITM + Bupivacaine QLB |
|---|---|---|
| Group 0 | 4 | 3 |
| Group 1 | 2 | 5 |
| Group 2 | 3 | 2 |
| Group 3 | 1 | 1 |
Presence or absence will be noted via a scale of 0-3 as follows: 0-no nausea, 1-mild nausea not requesting pharmacological rescue, 2-moderate nausea requesting pharmacological rescue, and 3-severe nausea resistant to pharmacological treatment
| Participants | ITM + Sham QLB | ITM + Bupivacaine QLB |
|---|---|---|
| Score 0 | 6 | 10 |
| Score 1 | 2 | 0 |
| Score 2 | 2 | 1 |
| Score 3 | 0 | 0 |
Will be measured in mmHG per standard of care and documented by study staff.
| mmHg | ITM + Sham QLB | ITM + Bupivacaine QLB |
|---|---|---|
| Systolic Blood Pressure | 113.69 ± 12.94 | 116.21 ± 12.05 |
Will be measured in rate/min per standard of care and documented by study staff
| Breaths/minute | ITM + Sham QLB | ITM + Bupivacaine QLB |
|---|---|---|
| Respiratory Rate | 16.54 ± 1.76 | 16.07 ± 1.27 |
Will be measured in % per standard of care and documented by study staff
| percentage of SpO2 | ITM + Sham QLB | ITM + Bupivacaine QLB |
|---|---|---|
| Oxygen Saturation | 96.6 ± 2.07 | 98.4 ± 2.07 |
VAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.
| units on a scale | ITM + Sham QLB | ITM + Bupivacaine QLB |
|---|---|---|
| Visual Analogue Scale (VAS) Pain Score at Rest | 3.5 ± 2.77 | 1.36 ± 1.65 |
VAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.
| units on a scale | ITM + Sham QLB | ITM + Bupivacaine QLB |
|---|---|---|
| Visual Analogue Scale (VAS) Pain Score at Rest | 3.14 ± 1.83 | 2.38 ± 2.14 |
VAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.
| units on a scale | ITM + Sham QLB | ITM + Bupivacaine QLB |
|---|---|---|
| Visual Analogue Scale (VAS) Pain Score at Rest | 3.73 ± 2.57 | 3.4 ± 2.63 |
Presence or absence will be noted via standard pruritus scale (0-3). 0 being no evidence of pruritus, group 1 being pruritus on diseased skin, group 2 being pruritus on non-diseased skin, and group 3 being chronic reactive lesions acquired from skin manipulation, such as rubbing, picking, or scratching
| Participants | ITM + Sham QLB | ITM + Bupivacaine QLB |
|---|---|---|
| Group 0 | 5 | 5 |
| Group 1 | 2 | 3 |
| Group 2 | 2 | 2 |
| Group 3 | 1 | 1 |
Presence or absence will be noted via standard pruritus scale (0-3). 0 being no evidence of pruritus, group 1 being pruritus on diseased skin, group 2 being pruritus on non-diseased skin, and group 3 being chronic reactive lesions acquired from skin manipulation, such as rubbing, picking, or scratching
| Participants | ITM + Sham QLB | ITM + Bupivacaine QLB |
|---|---|---|
| Group 0 | 8 | 10 |
| Group 1 | 1 | 0 |
| Group 2 | 1 | 1 |
| Group 3 | 0 | 0 |
Presence or absence will be noted via a scale of 0-3 as follows: 0-no nausea, 1-mild nausea not requesting pharmacological rescue, 2-moderate nausea requesting pharmacological rescue, and 3-severe nausea resistant to pharmacological treatment
| Participants | ITM + Sham QLB | ITM + Bupivacaine QLB |
|---|---|---|
| Score 0 | 9 | 10 |
| Score 1 | 1 | 0 |
| Score 2 | 0 | 1 |
| Score 3 | 0 | 0 |
Presence or absence will be noted via a scale of 0-3 as follows: 0-no nausea, 1-mild nausea not requesting pharmacological rescue, 2-moderate nausea requesting pharmacological rescue, and 3-severe nausea resistant to pharmacological treatment
| Participants | ITM + Sham QLB | ITM + Bupivacaine QLB |
|---|---|---|
| Score 0 | 8 | 11 |
| Score 1 | 2 | 0 |
| Score 2 | 0 | 0 |
| Score 3 | 0 | 0 |
Standard heart rate obtained
| Heartbeats/minute | ITM + Sham QLB | ITM + Bupivacaine QLB |
|---|---|---|
| Heart Rate | 82.62 ± 10.63 | 78.86 ± 15.94 |
Standard heart rate obtained
| Heartbeats/minute | ITM + Sham QLB | ITM + Bupivacaine QLB |
|---|---|---|
| Heart Rate | 86.86 ± 10.24 | 91.33 ± 6.15 |
Standard heart rate obtained
| Heartbeats/minute | ITM + Sham QLB | ITM + Bupivacaine QLB |
|---|---|---|
| Heart Rate | 87.00 ± 7.55 | 86.50 ± 3.54 |
Will be measured in mmHG per standard of care and documented by study staff.
| mmHg | ITM + Sham QLB | ITM + Bupivacaine QLB |
|---|---|---|
| Systolic Blood Pressure | 109.29 ± 9.41 | 111.00 ± 11.40 |
Will be measured in mmHG per standard of care and documented by study staff.
| mmHg | ITM + Sham QLB | ITM + Bupivacaine QLB |
|---|---|---|
| Systolic Blood Pressure | 117.6 ± 13.15 | 124.00 ± 5.66 |
Will be measured in mmHG per standard of care and documented by study staff.
| mmHg | ITM + Sham QLB | ITM + Bupivacaine QLB |
|---|---|---|
| Diastolic Blood Pressure | 71.15 ± 9.21 | 70.36 ± 2.29 |
Will be measured in mmHG per standard of care and documented by study staff.
| mmHg | ITM + Sham QLB | ITM + Bupivacaine QLB |
|---|---|---|
| Diastolic Blood Pressure | 68.00 ± 7.96 | 70.67 ± 8.96 |
Will be measured in mmHG per standard of care and documented by study staff.
| mmHg | ITM + Sham QLB | ITM + Bupivacaine QLB |
|---|---|---|
| Diastolic Blood Pressure | 75.80 ± 9.09 | 76.50 ± 7.78 |
Will be measured in rate/min per standard of care and documented by study staff
| Breaths/minute | ITM + Sham QLB | ITM + Bupivacaine QLB |
|---|---|---|
| Respiratory Rate | 16.29 ± 2.93 | 16.67 ± 1.51 |
Will be measured in rate/min per standard of care and documented by study staff
| Breaths/minute | ITM + Sham QLB | ITM + Bupivacaine QLB |
|---|---|---|
| Respiratory Rate | 16.40 ± 2.19 | 18.00 ± 0.00 |
Collected over Time of consent up to 48-hours post-operative. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ITM + Sham QLB | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| ITM + Bupivacaine QLB | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Age, Categorical(Participants) | ITM + Sham QLB | ITM + Bupivacaine QLB | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 11 | 21 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(Years) | ITM + Sham QLB | ITM + Bupivacaine QLB | Total |
|---|---|---|---|
| Mean | 31.80 ± 4.16 | 33.35 ± 5.17 | 32.55 ± 4.66 |
| Sex: Female, Male(Participants) | ITM + Sham QLB | ITM + Bupivacaine QLB | Total |
|---|---|---|---|
| Female | 10 | 11 | 21 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | ITM + Sham QLB | ITM + Bupivacaine QLB | Total |
|---|---|---|---|
| White, Caucasian (not Hispanic or Latino) | 10 | 11 | 21 |
| Black or African American (not Hispanic or Latino) | 4 | 2 | 6 |
| Hispanic or Latino | 0 | 0 | 0 |
| Asian (not Hispanic or Latino) | 1 | 0 | 1 |
| American Indian / Alaskan Native (not Hispanic or Latino) | 0 | 0 | 0 |
| Declined to answer | 0 | 1 | 1 |
| Region of Enrollment(participants) | ITM + Sham QLB | ITM + Bupivacaine QLB | Total |
|---|---|---|---|
| United States | 15 | 14 | 29 |
| Gravidity(Number of pregnancies) | ITM + Sham QLB | ITM + Bupivacaine QLB | Total |
|---|---|---|---|
| Mean | 2.93 ± 1.67 | 2.64 ± 1.08 | 2.79 ± 1.40 |
| Parity(Number of births) | ITM + Sham QLB | ITM + Bupivacaine QLB | Total |
|---|---|---|---|
| Mean | 1.27 ± 0.80 | 0.93 ± 0.47 | 1.10 ± 0.67 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Bupivacaine