A Phase 4 interventional study of Bupivacaine Hydrochloride 0.25% Injection Solution in Hysterectomy, sponsored by Jon I. Einarsson. Completed at 2 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-27.
Sponsored by Jon I. Einarsson · Phase 4, Interventional, and Treatment
The goal of this study is to assess the efficacy of a superior hypogastric plexus block (SHPB) for pain relief following a laparoscopic hysterectomy.
The objective of this study is to assess the efficacy of a SHPB for pain relief following laparoscopic hysterectomy. The superior hypogastric plexus lies in the presacral space and supplies autonomic innervation to the central pelvis. This plexus is suspected to play a role in postoperative pain following a hysterectomy. The investigators hypothesize that a SHPB using the anesthetic bupivacaine will reduce patients' pain scores and opioid consumption following a laparoscopic hysterectomy. Intraoperative and immediate postoperative opioid consumption will be collected from the Medication Administration Record by the nursing staff. The nursing staff will also be asked to complete a recovery worksheet that details the Visual Analog Scale pain score and opioid administration on admission to the recovery unit and every postoperative hour until six hours or the patient is discharged. Patients will also be asked to complete a daily diary for one week following the procedure, which details their pain level and daily opioid consumption. Patients will be followed for thirty days after surgery to assess for the occurrence of any postoperative complications. Detailed patient and procedure characteristics including age, race, body mass index, parity, surgical history, surgery indication, procedure type, and surgical approach will also be collected.
This is the only study on the registry with Jon I. Einarsson as lead sponsor.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Prior to the laparoscopic hysterectomy and any additional procedures, the SHPB will be performed on patients in the treatment arm. The block will contain 10 mL of 0.25% bupivacaine hydrochloride (Bupivacaine; 2.5 mg/mL = 25 mg). The anesthetic works by blocking nerve conduction and the steroid by reducing inflammation. The injection will be performed by tenting the presacral peritoneum, aspirating with a laparoscopic needle-tip syringe to ensure extravascular placement, and injecting the block.
Drug: Bupivacaine Hydrochloride 0.25% Injection Solution
Patients in the control arm will undergo the hysterectomy with no intervention.
10 mL of 0.25% bupivacaine hydrochloride (2.5 mg/mL = 25 mg)
Also known as: Bupivacaine
Postoperative Pain Scores
The primary outcome will be immediate postoperative patient pain scores using the Visual Analog Scale (VAS) in the recovery unit. Postoperative pain scores will be collected every one hour, on a scale from 1 to 10. Higher score indicates greater pain intensity. The score reported here is the mean VAS score in the first 2 hours.
Time frame: Admission to recovery unit and every hour after for 2 hours
Postoperative Opioid Use
Patients will be asked to complete a daily diary for one week that records their daily postoperative opioid consumption.
Time frame: Admission to recovery unit to 1 week post op, assessed up to 1 week after surgery
Postoperative Pain Scores
Patients will be asked to complete a daily diary for one week following the procedure, which details their pain level using VAS pain scores from the Brief Pain Inventory (BPI). Pain is reported on a scale of 1 to 10, and a higher score indicates greater pain intensity.
Time frame: Discharge to 1 week after surgery, assessed up to 1 week after surgery
| Milestone | Superior Hypogastric Plexus Block | No Block |
|---|---|---|
| Started | 50 | 50 |
| Completed | 44 | 50 |
| Not completed | 6 | 0 |
The primary outcome will be immediate postoperative patient pain scores using the Visual Analog Scale (VAS) in the recovery unit. Postoperative pain scores will be collected every one hour, on a scale from 1 to 10. Higher score indicates greater pain intensity. The score reported here is the mean VAS score in the first 2 hours.
| score on a scale | Superior Hypogastric Plexus Block | No Block |
|---|---|---|
| Postoperative Pain Scores | 3.9 (1.6 to 6.3) | 4.7 (3.2 to 6.2) |
Patients will be asked to complete a daily diary for one week that records their daily postoperative opioid consumption.
| milligrams morphine equivalents | Superior Hypogastric Plexus Block | No Block |
|---|---|---|
| postoperative day 0 | 5 (-1.9 to 11.9) | 10.2 (4 to 16.5) |
| postoperative day 1 | 2.5 (0 to 5) | 5 (0 to 10) |
| postoperative day 2 | 0 (-2.5 to 2.5) | 2.5 (0 to 5) |
| postoperative day 3 | 0 (-1.3 to 1.3) | 3.5 (1 to 6) |
| postoperative day 4 | 0 (-1.3 to 1.3) | 0 (-1.3 to 1.3) |
| postoperative day 5 | 0 (0 to 0) | 0 (0 to 0) |
| postoperative day 6 | 0 (0 to 0) | 0 (0 to 0) |
Patients will be asked to complete a daily diary for one week following the procedure, which details their pain level using VAS pain scores from the Brief Pain Inventory (BPI). Pain is reported on a scale of 1 to 10, and a higher score indicates greater pain intensity.
| score on a scale | Superior Hypogastric Plexus Block | No Block |
|---|---|---|
| postoperative day 0 | 5 (2.3 to 7.8) | 6 (4.6 to 7.4) |
| postoperative day 1 | 6.3 (4.5 to 8.1) | 5.6 (4.2 to 7) |
| postoperative day 2 | 5.5 (3.6 to 7.5) | 5 (3.9 to 6.2) |
| postoperative day 3 | 4.1 (2.4 to 5.8) | 4 (2.6 to 5.4) |
| postoperative day 4 | 4 (2.3 to 5.7) | 4 (2.5 to 5.5) |
| postoperative day 5 | 3 (1.5 to 4.6) | 3.5 (2.3 to 4.8) |
| postoperative day 6 | 2.8 (1.3 to 4.4) | 2.8 (1.6 to 4.1) |
Collected over one month after surgery for each study participant. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Superior Hypogastric Plexus Block | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| No Block | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| Age, Continuous(years) | Superior Hypogastric Plexus Block | No Block | Total |
|---|---|---|---|
| Median | 44 (40 to 48) | 45 (41 to 49) | 45 (41 to 48) |
| Sex: Female, Male(Participants) | Superior Hypogastric Plexus Block | No Block | Total |
|---|---|---|---|
| Female | 50 | 50 | 100 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Superior Hypogastric Plexus Block | No Block | Total |
|---|---|---|---|
| Race/Ethnicity — White/Caucasian | 35 | 29 | 64 |
| Race/Ethnicity — Black/African American | 8 | 14 | 22 |
| Race/Ethnicity — Hispanic | 2 | 2 | 4 |
| Race/Ethnicity — Asian | 2 | 2 | 4 |
| Race/Ethnicity — Other | 3 | 3 | 6 |
| Region of Enrollment(Participants) | Superior Hypogastric Plexus Block | No Block | Total |
|---|---|---|---|
| United States | 50 | 50 | 100 |
| Body Mass Index (BMI)(kg/m^2) | Superior Hypogastric Plexus Block | No Block | Total |
|---|---|---|---|
| Median | 28.7 (24.2 to 33.2) | 30.5 (25.4 to 35.6) | 29.5 (24.4 to 34) |
| Gravidity(Pregnancies) | Superior Hypogastric Plexus Block | No Block | Total |
|---|---|---|---|
| Median | 2 (0.5 to 3.5) | 2 (0.5 to 3.5) | 2 (0.5 to 3.5) |
| Parity(Pregnancies) | Superior Hypogastric Plexus Block | No Block | Total |
|---|---|---|---|
| Median | 2 (1.5 to 2.5) | 2 (0.5 to 3.5) | 2 (1 to 3) |
| Indication for Surgery(Participants) | Superior Hypogastric Plexus Block | No Block | Total |
|---|---|---|---|
| Fibroids | 25 | 20 | 45 |
| Abnormal Uterine Bleeding | 10 | 13 | 23 |
| Pelvic pain | 12 | 16 | 28 |
| Other | 3 | 1 | 4 |
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Studies of the drug tested here: Bupivacaine