A Phase 4 interventional study of Liposomal Bupivicaine and QL Block in Quadratus Lumborum Block and Surgical Wound Infiltration, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-03-05.
Sponsored by Duke University · Phase 4, Interventional, and Supportive care
The purpose of this study is to learn if using a Quadratus Lumborum (QL) plane injection technique (also called a "nerve block") that numbs the nerves going to the abdominal area improve pain control after surgery compared to administration of local anesthetic directly to the surgical incision. The QL block technique uses a numbing solution (local anesthetics) that is injected next to nerves located along muscles in the back to reduce pain. This block will not affect movement in the leg and/or make the legs weak. Some institutions, including Duke, use the QL block for patients having various abdominal surgeries, with the hope of providing good pain relief combined with improved mobility after surgery.
315 studies on the registry are indexed under Surgical Wound; 57 are open to participants now.
This study's enrollment of 44 is below the median of 66 across 242 interventional studies indexed under Surgical Wound.
Browse Surgical Wound studies →Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
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.
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.
Patients will receive a bilateral ultrasound guided QL block by the anesthesia team.
Procedure: QL Block
Patients will receive 266 mg of liposomal bupivacaine mixed with 50 mg non-liposomal bupivacaine infiltrated into the wound by the surgeon.
Drug: Liposomal Bupivicaine
Patient will receive liposomal bupivicaine mixed with non-liposomal bupivicaine directly to wound
Patient will receive ultrasound guided QL Block
Opioid Consumption in Oral Morphine Milliequivalents for the First 24 Hours After Surgery (Defined as 24 Hours After the Anesthesia End Time)
Time frame: 24 hours postoperatively
Self-reported Numeric Pain Scores on Postoperative Day Seven
Pain was measured on a self-reported scale of 0-10, where 0=no pain and 10=worst imaginable pain. Scores were gathered by phone on postoperative day 7.
Time frame: Postoperative day 7
Worst Bloating Severity in the First Postoperative Week
Bloating severity scores were gathered daily by phone interview for the first week postoperatively. Bloating severity was assessed on a scale of 1-5, where 1= not at all severe and 5=very much. The highest severity score reported during the week was collected for this outcome measure.
Time frame: First seven days postoperatively
Self-reported Ability to Walk for 15 Minutes Without Any Difficulty Within the First Postoperative Week
Physical function was assessed by daily phone interview during the first postoperative week. Subjects were asked to assess their ability to go for a walk of at least 15 minute on a scale of 1-5 with 1=unable to do and 5= able to do without any difficulty. For this outcome, the number of subjects who reported being able to go for a walk of at least 15 minutes "without any difficulty" at any time during the first postoperative week is reported.
Time frame: First seven days postoperatively
| Milestone | Quadratus Lumborum (QL) Block | Surgical Wound Infiltration |
|---|---|---|
| Started | 24 | 20 |
| Completed | 19 | 18 |
| Not completed | 5 | 2 |
| Withdrew: Lost to follow-up | 3 | 2 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| oral morphine equivalents in milligrams | Quadratus Lumborum (QL) Block | Surgical Wound Infiltration |
|---|---|---|
| Opioid Consumption in Oral Morphine Milliequivalents for the First 24 Hours After Surgery (Defined as 24 Hours After the Anesthesia End Time) | 17.50 (6.88 to 33.88) | 21.25 (7.50 to 46.88) |
Pain was measured on a self-reported scale of 0-10, where 0=no pain and 10=worst imaginable pain. Scores were gathered by phone on postoperative day 7.
| score on a scale | Quadratus Lumborum (QL) Block | Surgical Wound Infiltration |
|---|---|---|
| Self-reported Numeric Pain Scores on Postoperative Day Seven | 2 (1 to 3) | 1 (1 to 2) |
Bloating severity scores were gathered daily by phone interview for the first week postoperatively. Bloating severity was assessed on a scale of 1-5, where 1= not at all severe and 5=very much. The highest severity score reported during the week was collected for this outcome measure.
| score on a scale | Quadratus Lumborum (QL) Block | Surgical Wound Infiltration |
|---|---|---|
| Worst Bloating Severity in the First Postoperative Week | 4 (3 to 5) | 4 (2.75 to 5) |
Physical function was assessed by daily phone interview during the first postoperative week. Subjects were asked to assess their ability to go for a walk of at least 15 minute on a scale of 1-5 with 1=unable to do and 5= able to do without any difficulty. For this outcome, the number of subjects who reported being able to go for a walk of at least 15 minutes "without any difficulty" at any time during the first postoperative week is reported.
| Participants | Quadratus Lumborum (QL) Block | Surgical Wound Infiltration |
|---|---|---|
| Self-reported Ability to Walk for 15 Minutes Without Any Difficulty Within the First Postoperative Week | 10 | 12 |
Collected over Up to 7 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Quadratus Lumborum (QL) Block | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| Surgical Wound Infiltration | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
The number of participants in the QL group excludes two subjects-- one subject who voluntarily withdrew and one who was withdrawn by the PI for a surgical site infection.
| Age, Continuous(years) | Quadratus Lumborum (QL) Block | Surgical Wound Infiltration | Total |
|---|---|---|---|
| Mean | 42.59 ± 14.41 | 47.90 ± 12.51 | 45.25 ± 13.46 |
| Sex: Female, Male(Participants) | Quadratus Lumborum (QL) Block | Surgical Wound Infiltration | Total |
|---|---|---|---|
| Female | 15 | 13 | 28 |
| Male | 7 | 7 | 14 |
| Ethnicity (NIH/OMB)(Participants) | Quadratus Lumborum (QL) Block | Surgical Wound Infiltration | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 22 | 19 | 41 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Quadratus Lumborum (QL) Block | Surgical Wound Infiltration | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 6 | 4 | 10 |
| White | 16 | 16 | 32 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Quadratus Lumborum (QL) Block | Surgical Wound Infiltration | Total |
|---|---|---|---|
| United States | 22 | 20 | 42 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Bupivacaine