Clinical trial NCT05257941: ESP Block VS Intrathecal Opioid After Laparoscopic Colorectal Surgery
Official title: Randomized Prospective Study Comparison of Erector Spinae Plane Block and Intrathecal Opioid for Postoperative Analgesia After Laparoscopic Colorectal Surgery in an Enhanced Recovery Setting
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Surgery
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2022-02-25
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: cumulated oral morphine equivalent (OME)
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: opioid consumption
timeFrame: 1 hour after surgery
measure: opioid consumption
timeFrame: 12 hours after surgery
measure: opioid consumption
timeFrame: 24 hours after surgery
measure: opioid consumption
timeFrame: 48 hours after surgery
measure: opioid consumption
timeFrame: 72 hours after surgery
measure: Visual Analog Scale pain scores
timeFrame: 1 hour after surgery
measure: Visual Analog Scale pain scores
timeFrame: 12 hours after surgery
measure: Visual Analog Scale pain scores
timeFrame: 24 hours after surgery
measure: Visual Analog Scale pain scores
timeFrame: 48 hours after surgery
measure: Visual Analog Scale pain scores
timeFrame: 72 hours after surgery
measure: opioid side effects
timeFrame: duration of hospital stay up to 72 hours
measure: first ambulation
timeFrame: duration of hospital stay up to 72 hours
measure: first flatus
timeFrame: duration of hospital stay up to 72 hours
measure: oral liquid
timeFrame: duration of hospital stay up to 72 hours
measure: oral food
timeFrame: duration of hospital stay up to 72 hours
measure: hospital stay
timeFrame: duration of hospital stay up to 7 days
measure: patient's satisfaction scores
timeFrame: 24 hours after surgery
measure: patient's satisfaction scores
timeFrame: 48 hours after surgery
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: IU Health University Hospital
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Amy McCutchan, MD
role: PRINCIPAL_INVESTIGATOR
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