ESP Block VS Intrathecal Opioid After Laparoscopic Colorectal Surgery

NCT ID: NCT05257941

Last Updated: 2024-12-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-27
• Study Completion Date: 2024-08-29

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IT Injection

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

Group Type: ACTIVE_COMPARATOR

IT Injection

Intervention Type: DRUG

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

ESP Block

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

Group Type: ACTIVE_COMPARATOR

ESP Block

Intervention Type: DRUG

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

Interventions

IT Injection

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

Intervention Type: DRUG

ESP Block

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Amy McCutchan

Assistant Professor of Clinical Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amy McCutchan, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

IU Health University Hospital

Indianapolis, Indiana, United States

Countries

United States

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

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Other Identifiers

12514

Identifier Type: -

Identifier Source: org_study_id