ESP Block VS Intrathecal Opioid After Laparoscopic Colorectal Surgery
- Conditions
- Surgery
- Interventions
- Drug: ESP BlockDrug: IT Injection
- Registration Number
- NCT05257941
- Lead Sponsor
- Indiana University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 116
- 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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ESP Block ESP Block an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back. IT Injection IT Injection an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
- Primary Outcome Measures
Name Time Method cumulated oral morphine equivalent (OME) 24 hours after surgery morphine consumption
- Secondary Outcome Measures
Name Time Method oral food duration of hospital stay up to 72 hours time to first oral food intake
first ambulation duration of hospital stay up to 72 hours time to patient first ambulation
first flatus duration of hospital stay up to 72 hours time to first flatus
patient's satisfaction scores 48 hours after surgery assess patient's satisfaction with care (1-10 with 1 being the least satisfied and 10 being the most satisfied)
opioid side effects duration of hospital stay up to 72 hours incidence of opioid side effects (nausea, pruritus, urinary retention, respiratory depression, ileus)
opioid consumption 72 hours after surgery opioid consumption in OME
Visual Analog Scale pain scores 72 hours after surgery pain scores using the Visual Analog Scale (0-10 with 0 being no pain and 10 being the worst pain)
hospital stay duration of hospital stay up to 7 days amount of time each subject spends in the hospital before discharge
oral liquid duration of hospital stay up to 72 hours time to first oral liquid intake
Trial Locations
- Locations (1)
IU Health University Hospital
🇺🇸Indianapolis, Indiana, United States