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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative opioid consumption 0- 72 hours after surgery | 0-72 hours after time 0 (end of surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Complications related to rectus sheath block or epidural analgesia | Inadvertent dural puncture, postdural puncture headache, need to discontinue epidural due to hypotension, epidural hematoma. | 0-72 hours after time 0 (end of surgery) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashraf Habib, M.D. | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
Data will be shared upon reasonable request
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| ID | Term |
|---|---|
| D013662 | Tea |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
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| 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 |
|
| 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) | Visual analog scores 0-10 (0=no pain, 10=worst possible pain) | 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) | 0-72 hours after time 0 (end of surgery) |
| 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 |
| D000066888 |
| Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |