Skip to main content
OpenTrials
Completed

NCT Number: NCT06575699

Rectus Sheath Block for Analgesia After Gynecological Laparotomy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gynecologic Surgical Procedures

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients ≥18 years presenting for a laparotomy for Gynecologic malignancy with a vertical incision.
  • ASA Classification II or III.
  • English speaking patients

Exclusion criteria

  • 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)

Treatment and study plan

Rectus sheath block

Procedure

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 analgesia

Procedure

Low thoracic Epidural Analgesia.

Liposomal bupivacaine

Drug

133 mg liposomal bupivacaine per side for rectus sheath block

Bupivacaine Hydrochloride

Drug

20 mL bupivacaine 0.25% per side for rectus sheath block

Bupivacaine-Hydromorphone Cassette

Drug

Bupivacaine 0.625% with hydromorphone 10 mcg/ml for the epidural solution

Primary outcomes

  1. Postoperative opioid consumption 0- 72 hours after surgery

    Time frame: 0-72 hours after time 0 (end of surgery)

Secondary outcomes

  1. 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)

  2. Number of patients with intraoperative hypotension

    Time frame: Intraoperative

  3. Number of patients with postoperative hypotension

    Time frame: 0-72 hours after time 0 (end of surgery)

  4. Number of patients receiving rescue antiemetics

    Time frame: 0-72 hours after time 0 (end of surgery)

  5. Number of patients receiving rescue antipruritics

    Time frame: 0-72 hours after time 0 (end of surgery)

  6. Number of patients developing ileus or constipation

    Time frame: 0-72 hours after time 0 (end of surgery)

  7. Number of patients with respiratory Depression

    Time frame: 0-72 hours after time 0 (end of surgery)

  8. 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)

    Visual analog scores 0-10 (0=no pain, 10=worst possible pain)

  9. Maximum pain scores reported

    Time frame: 0-72 hours after time 0 (end of surgery)

    Visual analog scores 0-10 (0=no pain, 10=worst possible pain)

  10. Time to mobilization

    Time frame: 0-72 hours after time 0 (end of surgery)

  11. Time to urinary catheter removal

    Time frame: 0-72 hours after time 0 (end of surgery)

  12. Duration of post anesthesia care unit (PACU) stay

    Time frame: 0-6 hours after time 0 (end of surgery)

  13. Duration of hospital stay

    Time frame: 0-10 days after surgery

  14. Number of patients receiving intraoperative vasopressors

    Time frame: Intraoperative

Other outcomes

  1. Complications related to rectus sheath block or epidural analgesia

    Time frame: 0-72 hours after time 0 (end of surgery)

    Inadvertent dural puncture, postdural puncture headache, need to discontinue epidural due to hypotension, epidural hematoma.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Rectus Sheath Block With Liposomal Bupivacaine for Postoperative Analgesia Following Gynecologic Oncology Surgery: A Pilot Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 28, 2024
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.