ESP Block VS Intrathecal Opioid After Laparoscopic Colorectal Surgery

NCT05257941 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: 12514
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

• 24 Hour Cumulated Oral Morphine Equivalent (OME)

  24 hour cumulated oral morphine consumption (OME)

  24 hours after surgery

Secondary Outcomes (19)

• Oral Morphine Equivalents (OME)

  1 hour after surgery

• Oral Morphine Equivalents (OME)

  12 hours after surgery

• Oral Morphine Equivalents (OME)

  24 hours after surgery

• Oral Morphine Equivalents (OME)

  48 hours after surgery

• Oral Morphine Equivalents (OME)

  72 hours after surgery

Study Arms (2)

IT Injection

ACTIVE COMPARATOR

an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid

Drug: IT Injection

ESP Block

ACTIVE COMPARATOR

an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back.

Drug: ESP Block

Interventions

IT Injection DRUG

an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid

Also known as: Intrathecal (IT)

IT Injection

ESP Block DRUG

an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back

Also known as: Erector Spinae Plane Block (ESP)

ESP Block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

IU Health University Hospital

Indianapolis, Indiana, 46202, United States

Location

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MeSH Terms

Interventions

Injections, Spinal

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Amy McCutchan
• Organization: Indiana University

almccutc@iu.edu

317-274-0275

Study Officials

• Amy McCutchan, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Anesthesiology

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 25, 2022
• Study Start: January 27, 2022
• Primary Completion: August 26, 2024
• Study Completion: August 29, 2024
• Last Updated: March 2, 2026
• Results First Posted: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)