Pain relief after gynecological surgery using a specific nerve block technique
Rectus Sheath Block With Liposomal Bupivacaine for Postoperative Analgesia Following Gynecologic Oncology Surgery: A Pilot Study
This study is testing if a specific nerve block technique using a special pain medication can help women feel less pain after gynecological surgery compared to the usual pain relief methods.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06575699 on ClinicalTrials.gov |
What this trial studies
This clinical trial involves thirty patients undergoing laparotomy for gynecologic oncology surgery who will receive a bilateral rectus sheath block (RSB) using ultrasound guidance. The intervention includes administering liposomal bupivacaine and bupivacaine to manage postoperative pain. Participants will be matched with historical controls who received thoracic epidural analgesia based on age, race, insurance status, and duration of surgery to evaluate the effectiveness of the RSB. The study aims to assess the analgesic benefits of this technique compared to traditional methods.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older undergoing laparotomy for gynecologic malignancy with a vertical incision.
Not a fit: Patients with a BMI over 50 kg/m2 or those on chronic opioid therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide improved pain management for patients undergoing gynecological surgeries.
How similar studies have performed: Other studies have shown promising results with similar nerve block techniques for postoperative pain management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients ≥18 years presenting for a laparotomy for Gynecologic malignancy with a vertical incision. 2. ASA Classification II or III. 3. English speaking patients Exclusion Criteria: 1. BMI \>50 kg/m2. 2. Chronic pain or chronic opioid therapy. 3. Allergy or contraindication to local anesthetics or any component of the multimodal analgesic regimen (NSAIDs and acetaminophen)
Where this trial is running
Durham, North Carolina
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Ashraf Habib, M.D. — Duke University
- Study coordinator: Ashraf Habib, MBBCh, MSc, MHSc, FRCA
- Email: habib001@mc.duke.edu
- Phone: 9196682024
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.