Randomized Prospective Study Comparison of Erector Spinae Plane Block and Intrathecal Opioid for Postoperative Analgesia After Laparoscopic Colorectal Surgery in an Enhanced Recovery Setting

12514

This study is being done to compare 2 types of pain control methods and determine which is more effective postoperatively for laparoscopic colorectal surgery. Group 1 will receive an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid. Group 2 will receive an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back.

2022-01-27

2024-09-01

2024-09-07

Recruiting

Early phase I

126

Inclusion Criteria: * Patients undergoing an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital * ASA Class 1, 2, 3 (American Society of Anesthesiologists physical status classification system) * Age 18 to 80 years (male or female) * BMI \< 40kg/m2 * Desires regional anesthesia for postoperative pain control Exclusion Criteria: * Any contraindication for neuraxial analgesia or ESP block procedure * Contraindications for neuraxial analgesia include: Elevated intracranial pressure (except in cases of pseudo-tumor cerebri), infection at the site of injection, lack of consent from the patient, patient refusal, true allergy to any drug used in the spine, and uncorrected hypovolemia. * Contraindications for ESP block procedure include: Infection at the site of injection, patient refusal, true allergy to any of the drugs used in the block, and lack of patient consent. * Any patient undergoing a laparoscopic abdominoperineal resection. * Any physical, mental or medical conditions which, in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery. * Known true allergy to the study medications (morphine, bupivacaine, decadron, Tylenol, Celebrex) * Takes over 30 mg of oral morphine equivalents daily * Any history of substance abuse in the past 6 months * End stage liver disease, end stage renal disease * Body weight of \< 50 kg

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 126, 'type': 'ESTIMATED'}}

2024-03-19