Gynecologic Surgical Procedures
Conditions
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.
Interventions
PROCEDURERectus sheath block
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.
PROCEDUREThoracic Epidural Analgesia
Low thoracic Epidural Analgesia.
DRUGLiposomal bupivacaine
133 mg liposomal bupivacaine per side for rectus sheath block
DRUGBupivacaine Hydrochloride
20 mL bupivacaine 0.25% per side for rectus sheath block
DRUGBupivacaine-Hydromorphone Cassette
Bupivacaine 0.625% with hydromorphone 10 mcg/ml for the epidural solution
Sponsors
Duke University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative opioid consumption 0- 72 hours after surgery | 0-72 hours after time 0 (end of surgery) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 with intraoperative hypotension | Intraoperative | — |
| Number of patients with postoperative hypotension | 0-72 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 rescue antipruritics | 0-72 hours after time 0 (end of surgery) | — |
| 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) | — |
| 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) | Visual analog scores 0-10 (0=no pain, 10=worst possible pain) |
| Maximum pain scores reported | 0-72 hours after time 0 (end of surgery) | Visual analog scores 0-10 (0=no pain, 10=worst possible pain) |
| Time to mobilization | 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 receiving intraoperative vasopressors | Intraoperative | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAshraf Habib, M.D.
Duke University
Outcome results
None listed