Gynecologic Surgical ProceduresPhase 4NCT06575699
Rectus Sheath Block for Analgesia After Gynecological Laparotomy
A Phase 4 study testing Rectus sheath block, Thoracic Epidural Analgesia and Liposomal bupivacaine in people with Gynecologic Surgical Procedures, run by Duke University at 1 site in United States.
Trial summary
Thirty subjects undergoing laparotomy for Gynecologic oncology surgery will be prospectively enrolled and will receive a bilateral rectus sheath block (RSB) under ultrasound guidance using 133 mg liposomal bupivacaine and 20 ml bupivacaine 0.25% per side. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Surgical Procedures
- What is being tested?
- Rectus sheath block, Thoracic Epidural Analgesia and Liposomal bupivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2024to 28 Nov 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥18 years presenting for a laparotomy for Gynecologic malignancy with a vertical incision.
- ASA Classification II or III.
- English speaking patients
Who cannot join
- BMI >50 kg/m2.
- Chronic pain or chronic opioid therapy.
- Allergy or contraindication to local anesthetics or any component of the multimodal analgesic regimen (NSAIDs and acetaminophen)
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Rectus Sheath Block With Liposomal Bupivacaine for Postoperative Analgesia Following Gynecologic Oncology Surgery: A Pilot Study
Thirty subjects undergoing laparotomy for Gynecologic oncology surgery will be prospectively enrolled and will receive a bilateral rectus sheath block (RSB) under ultrasound guidance using 133 mg liposomal bupivacaine and 20 ml bupivacaine 0.25% per side. Cases will be matched in a 1:2 ratio by age, race, insurance status and duration of surgery with historical controls who received postoperative analgesia using thoracic epidural analgesia.
- Conditions
- Gynecologic Surgical Procedures
- Being tested
- Rectus sheath block, Thoracic Epidural Analgesia, Liposomal bupivacaine, Bupivacaine Hydrochloride, Bupivacaine-Hydromorphone Cassette
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectus sheath blockProcedure or surgery
bilateral rectus sheath block under ultrasound guidance using 133 mg liposomal bupivacaine and 20 ml bupivacaine 0.25% per side deposited between the rectus abdomens muscle and the posterior rectus sheath.
Thoracic Epidural AnalgesiaProcedure or surgery
Low thoracic Epidural Analgesia.
Liposomal bupivacaineDrug
133 mg liposomal bupivacaine per side for rectus sheath block
Bupivacaine HydrochlorideDrug
20 mL bupivacaine 0.25% per side for rectus sheath block
Bupivacaine-Hydromorphone CassetteDrug
Bupivacaine 0.625% with hydromorphone 10 mcg/ml for the epidural solution
| Study group | Role | What they receive |
|---|---|---|
| Rectus Sheath Block Group (Prospective arm) | Experimental | Thirty subjects will be prospectively enrolled and will receive a bilateral rectus sheath block under ultrasound guidance using 133 mg liposomal bupivacaine and 20 ml bupivacaine 0.25% per side. Receives: Procedure: Rectus sheath block; Drug: Liposomal bupivacaine; Drug: Bupivacaine Hydrochloride |
| Thoracic Epidural Analgesia Group (retrospective arm) | Active comparator | 60 patients who received thoracic epidural analgesia as part of our enhanced recovery after surgery protocol and stayed in hospital for at least 72 h. Receives: Procedure: Thoracic Epidural Analgesia; Drug: Bupivacaine-Hydromorphone Cassette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative opioid consumption 0- 72 hours after surgery
Measured: 0-72 hours after time 0 (end of surgery)
Secondary outcomes (14)
Total postsurgical opioid consumption at 0-24, 24-48, and 48-72 hours
Measured: 0-24 hours, 24-48 hours and 48-72 hours after time 0 (end of surgery)
Number of patients with intraoperative hypotension
Measured: Intraoperative
Number of patients with postoperative hypotension
Measured: 0-72 hours after time 0 (end of surgery)
Number of patients receiving rescue antiemetics
Measured: 0-72 hours after time 0 (end of surgery)
Number of patients receiving rescue antipruritics
Measured: 0-72 hours after time 0 (end of surgery)
Number of patients developing ileus or constipation
Measured: 0-72 hours after time 0 (end of surgery)
Number of patients with respiratory Depression
Measured: 0-72 hours after time 0 (end of surgery)
Area under the curve (AUC) of visual analog scale (VAS) pain intensity scores through 72 hours (AUC0-72)
Visual analog scores 0-10 (0=no pain, 10=worst possible pain)
Measured: 0-72 hours after time 0 (end of surgery)
Maximum pain scores reported
Visual analog scores 0-10 (0=no pain, 10=worst possible pain)
Measured: 0-72 hours after time 0 (end of surgery)
Time to mobilization
Measured: 0-72 hours after time 0 (end of surgery)
Time to urinary catheter removal
Measured: 0-72 hours after time 0 (end of surgery)
Duration of post anesthesia care unit (PACU) stay
Measured: 0-6 hours after time 0 (end of surgery)
Duration of hospital stay
Measured: 0-10 days after surgery
Number of patients receiving intraoperative vasopressors
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start10 Oct 2024
- Primary completion28 Nov 2025
- Study completion28 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic Surgical ProceduresStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashraf Habib, M.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06575699
- Sponsor's protocol ID
- Pro00115981
- Status last verified
- Jan 2026
- First submitted
- 22 Aug 2024
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectus Sheath Block With Liposomal Bupivacaine for Postoperative Analgesia Following Gynecologic Oncology Surgery: A Pilot Study
- ClinicalTrials.gov ID
- NCT06575699
- Acronym / sponsor ID
- Pro00115981
- Conditions
- Gynecologic Surgical Procedures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 28 Nov 2025 (actual)
- Study completion
- 28 Nov 2025 (actual)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Thirty subjects undergoing laparotomy for Gynecologic oncology surgery will be prospectively enrolled and will receive a bilateral rectus sheath block (RSB) under ultrasound guidance using 133 mg liposomal bupivacaine and 20 ml bupivacaine 0.25% per side. Cases will be matched in a 1:2 ratio by age, race, insurance status and duration of surgery with historical controls who received postoperative analgesia using thoracic epidural analgesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rectus Sheath Block Group (Prospective arm) | Experimental | Procedure: Rectus sheath block, Drug: Liposomal bupivacaine, Drug: Bupivacaine HydrochlorideThirty subjects will be prospectively enrolled and will receive a bilateral rectus sheath block under ultrasound guidance using 133 mg liposomal bupivacaine and 20 ml bupivacaine 0.25% per side. |
| Thoracic Epidural Analgesia Group (retrospective arm) | Active comparator | Procedure: Thoracic Epidural Analgesia, Drug: Bupivacaine-Hydromorphone Cassette60 patients who received thoracic epidural analgesia as part of our enhanced recovery after surgery protocol and stayed in hospital for at least 72 h. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients ≥18 years presenting for a laparotomy for Gynecologic malignancy with a vertical incision.
- ASA Classification II or III.
- English speaking patients
Key exclusion criteria (3 listed)
- BMI >50 kg/m2.
- Chronic pain or chronic opioid therapy.
- Allergy or contraindication to local anesthetics or any component of the multimodal analgesic regimen (NSAIDs and acetaminophen)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rectus sheath blockbilateral rectus sheath block under ultrasound guidance using 133 mg liposomal bupivacaine and 20 ml bupivacaine 0.25% per side deposited between the rectus abdomens muscle and the posterior rectus sheath. | Procedure or surgery | Rectus Sheath Block Group (Prospective arm) |
| Thoracic Epidural AnalgesiaLow thoracic Epidural Analgesia. | Procedure or surgery | Thoracic Epidural Analgesia Group (retrospective arm) |
| Liposomal bupivacaine133 mg liposomal bupivacaine per side for rectus sheath block | Drug | Rectus Sheath Block Group (Prospective arm) |
| Bupivacaine Hydrochloride20 mL bupivacaine 0.25% per side for rectus sheath block | Drug | Rectus Sheath Block Group (Prospective arm) |
| Bupivacaine-Hydromorphone CassetteBupivacaine 0.625% with hydromorphone 10 mcg/ml for the epidural solution | Drug | Thoracic Epidural Analgesia Group (retrospective arm) |
Primary outcome
Postoperative opioid consumption 0- 72 hours after surgery
Time frame: 0-72 hours after time 0 (end of surgery)
14 secondary outcomes
Total postsurgical opioid consumption at 0-24, 24-48, and 48-72 hours
Time frame: 0-24 hours, 24-48 hours and 48-72 hours after time 0 (end of surgery)
Number of patients with intraoperative hypotension
Time frame: Intraoperative
Number of patients with postoperative hypotension
Time frame: 0-72 hours after time 0 (end of surgery)
Number of patients receiving rescue antiemetics
Time frame: 0-72 hours after time 0 (end of surgery)
Number of patients receiving rescue antipruritics
Time frame: 0-72 hours after time 0 (end of surgery)
Number of patients developing ileus or constipation
Time frame: 0-72 hours after time 0 (end of surgery)
Number of patients with respiratory Depression
Time frame: 0-72 hours after time 0 (end of surgery)
Area under the curve (AUC) of visual analog scale (VAS) pain intensity scores through 72 hours (AUC0-72)
Time frame: 0-72 hours after time 0 (end of surgery)
Maximum pain scores reported
Time frame: 0-72 hours after time 0 (end of surgery)
Time to mobilization
Time frame: 0-72 hours after time 0 (end of surgery)
Time to urinary catheter removal
Time frame: 0-72 hours after time 0 (end of surgery)
Duration of post anesthesia care unit (PACU) stay
Time frame: 0-6 hours after time 0 (end of surgery)
Duration of hospital stay
Time frame: 0-10 days after surgery
Number of patients receiving intraoperative vasopressors
Time frame: Intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: No. Data will be shared upon reasonable request
Related trials for Gynecologic Surgical Procedures
RecruitingObservational study
GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications
GYN Disorders
Active, not recruiting
A Study of Near-Infrared Fluorescence Imaging With ICG During Reconstructive Gynecologic Surgery
Gynecologic Surgery
Enrolling by invitation
Long-term Follow-up of Bio-signals and Quality of Recovery Following Implementation of ERAS Based on the Mobile Application
Gynecologic Surgery, General Anesthesia
Not yet recruitingPhase 4
Perioperative Esketamine Safety and Efficacy in Reducing Postoperative ENDometriosis PAIN (the ENDPAIN Trial): a Randomized Controlled Trial.
Endometriosis
Active, not recruiting
EXORA Block vs Epidural Analgesia in Gynecological Surgery
Pain, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashraf Habib, M.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rectus sheath block, Thoracic Epidural Analgesia and Liposomal bupivacaine in people with Gynecologic Surgical Procedures, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative opioid consumption 0- 72 hours after surgery (time frame: 0-72 hours after time 0 (end of surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.