Status:

TERMINATED

ESP Block VS Intrathecal Opioid After Laparoscopic Colorectal Surgery

Lead Sponsor:

Indiana University

Conditions:

Surgery

Eligibility:

All Genders

18-80 years

Phase:

PHASE1

PHASE2

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) ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 27 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 29 2024

Estimated Enrollment :

116 Patients enrolled

Trial Details

Trial ID

NCT05257941

Start Date

January 27 2022

End Date

August 29 2024

Last Update

December 13 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

IU Health University Hospital

Indianapolis, Indiana, United States, 46202