Clinical trial NCT06575699: Rectus Sheath Block for Analgesia After Gynecological Laparotomy
Official title: Rectus Sheath Block With Liposomal Bupivacaine for Postoperative Analgesia Following Gynecologic Oncology Surgery: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Gynecologic Surgical Procedures
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.


Eligibility 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)

Primary outcomes:
measure: Postoperative opioid consumption 0- 72 hours after surgery
timeFrame: 0-72 hours after time 0 (end of surgery)
Secondary outcomes:
measure: Total postsurgical opioid consumption at 0-24, 24-48, and 48-72 hours
timeFrame: 0-24 hours, 24-48 hours and 48-72 hours after time 0 (end of surgery)
measure: Number of patients with intraoperative hypotension
timeFrame: Intraoperative
measure: Number of patients with postoperative hypotension
timeFrame: 0-72 hours after time 0 (end of surgery)
measure: Number of patients receiving rescue antiemetics
timeFrame: 0-72 hours after time 0 (end of surgery)
measure: Number of patients receiving rescue antipruritics
timeFrame: 0-72 hours after time 0 (end of surgery)
measure: Number of patients developing ileus or constipation
timeFrame: 0-72 hours after time 0 (end of surgery)
measure: Number of patients with respiratory Depression
timeFrame: 0-72 hours after time 0 (end of surgery)
measure: Area under the curve (AUC) of visual analog scale (VAS) pain intensity scores through 72 hours (AUC0-72)
timeFrame: 0-72 hours after time 0 (end of surgery)
measure: Maximum pain scores reported
timeFrame: 0-72 hours after time 0 (end of surgery)
measure: Time to mobilization
timeFrame: 0-72 hours after time 0 (end of surgery)
measure: Time to urinary catheter removal
timeFrame: 0-72 hours after time 0 (end of surgery)
measure: Duration of post anesthesia care unit (PACU) stay
timeFrame: 0-6 hours after time 0 (end of surgery)
measure: Duration of hospital stay
timeFrame: 0-10 days after surgery
measure: Number of patients receiving intraoperative vasopressors
timeFrame: Intraoperative
Other outcomes:
measure: Complications related to rectus sheath block or epidural analgesia
timeFrame: 0-72 hours after time 0 (end of surgery)
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Ashraf Habib, M.D.
role: PRINCIPAL_INVESTIGATOR
References: