Rectus Sheath Block With Liposomal Bupivacaine for Postoperative Analgesia Following Gynecologic Oncology Surgery: A Pilot Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Postoperative opioid consumption 0- 72 hours after surgery
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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/m
- •Chronic pain or chronic opioid therapy.
- •Allergy or contraindication to local anesthetics or any component of the multimodal analgesic regimen (NSAIDs and acetaminophen)
Arms & Interventions
Rectus Sheath Block Group (Prospective arm)
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.
Intervention: Rectus sheath block (Procedure)
Rectus Sheath Block Group (Prospective arm)
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.
Intervention: Liposomal bupivacaine (Drug)
Rectus Sheath Block Group (Prospective arm)
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.
Intervention: Bupivacaine Hydrochloride (Drug)
Thoracic Epidural Analgesia Group (retrospective arm)
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.
Intervention: Thoracic Epidural Analgesia (Procedure)
Thoracic Epidural Analgesia Group (retrospective arm)
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.
Intervention: Bupivacaine-Hydromorphone Cassette (Drug)
Outcomes
Primary Outcomes
Postoperative opioid consumption 0- 72 hours after surgery
Time Frame: 0-72 hours after time 0 (end of surgery)
Secondary Outcomes
- Area under the curve (AUC) of visual analog scale (VAS) pain intensity scores through 72 hours (AUC0-72)(0-72 hours after time 0 (end of surgery))
- Maximum pain scores reported(0-72 hours after time 0 (end of surgery))
- Time to mobilization(0-72 hours after time 0 (end of surgery))
- Total postsurgical opioid consumption at 0-24, 24-48, and 48-72 hours(0-24 hours, 24-48 hours and 48-72 hours after time 0 (end of surgery))
- Number of patients receiving rescue antiemetics(0-72 hours after time 0 (end of surgery))
- Number of patients receiving intraoperative vasopressors(Intraoperative)
- Number of patients with intraoperative hypotension(Intraoperative)
- Number of patients developing ileus or constipation(0-72 hours after time 0 (end of surgery))
- Number of patients with respiratory Depression(0-72 hours after time 0 (end of surgery))
- Time to urinary catheter removal(0-72 hours after time 0 (end of surgery))
- Duration of post anesthesia care unit (PACU) stay(0-6 hours after time 0 (end of surgery))
- Duration of hospital stay(0-10 days after surgery)
- Number of patients with postoperative hypotension(0-72 hours after time 0 (end of surgery))
- Number of patients receiving rescue antipruritics(0-72 hours after time 0 (end of surgery))