ESP Block VS Intrathecal Opioid After Laparoscopic Colorectal Surgery

March 17, 2024 updated by: Amy McCutchan, Indiana University

Randomized Prospective Study Comparison of Erector Spinae Plane Block and Intrathecal Opioid for Postoperative Analgesia After Laparoscopic Colorectal Surgery in an Enhanced Recovery Setting

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

126

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • IU Health University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: IT Injection
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
an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
Active Comparator: ESP Block
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
an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cumulated oral morphine equivalent (OME)
Time Frame: 24 hours after surgery
morphine consumption
24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
opioid consumption
Time Frame: 1 hour after surgery
opioid consumption in OME
1 hour after surgery
opioid consumption
Time Frame: 12 hours after surgery
opioid consumption in OME
12 hours after surgery
opioid consumption
Time Frame: 24 hours after surgery
opioid consumption in OME
24 hours after surgery
opioid consumption
Time Frame: 48 hours after surgery
opioid consumption in OME
48 hours after surgery
opioid consumption
Time Frame: 72 hours after surgery
opioid consumption in OME
72 hours after surgery
Visual Analog Scale pain scores
Time Frame: 1 hour after surgery
pain scores using the Visual Analog Scale (0-10 with 0 being no pain and 10 being the worst pain)
1 hour after surgery
Visual Analog Scale pain scores
Time Frame: 12 hours after surgery
pain scores using the Visual Analog Scale (0-10 with 0 being no pain and 10 being the worst pain)
12 hours after surgery
Visual Analog Scale pain scores
Time Frame: 24 hours after surgery
pain scores using the Visual Analog Scale (0-10 with 0 being no pain and 10 being the worst pain)
24 hours after surgery
Visual Analog Scale pain scores
Time Frame: 48 hours after surgery
pain scores using the Visual Analog Scale (0-10 with 0 being no pain and 10 being the worst pain)
48 hours after surgery
Visual Analog Scale pain scores
Time Frame: 72 hours after surgery
pain scores using the Visual Analog Scale (0-10 with 0 being no pain and 10 being the worst pain)
72 hours after surgery
opioid side effects
Time Frame: duration of hospital stay up to 72 hours
incidence of opioid side effects (nausea, pruritus, urinary retention, respiratory depression, ileus)
duration of hospital stay up to 72 hours
first ambulation
Time Frame: duration of hospital stay up to 72 hours
time to patient first ambulation
duration of hospital stay up to 72 hours
first flatus
Time Frame: duration of hospital stay up to 72 hours
time to first flatus
duration of hospital stay up to 72 hours
oral liquid
Time Frame: duration of hospital stay up to 72 hours
time to first oral liquid intake
duration of hospital stay up to 72 hours
oral food
Time Frame: duration of hospital stay up to 72 hours
time to first oral food intake
duration of hospital stay up to 72 hours
hospital stay
Time Frame: duration of hospital stay up to 7 days
amount of time each subject spends in the hospital before discharge
duration of hospital stay up to 7 days
patient's satisfaction scores
Time Frame: 24 hours after surgery
assess patient's satisfaction with care (1-10 with 1 being the least satisfied and 10 being the most satisfied)
24 hours after surgery
patient's satisfaction scores
Time Frame: 48 hours after surgery
assess patient's satisfaction with care (1-10 with 1 being the least satisfied and 10 being the most satisfied)
48 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: Amy McCutchan, MD, Indiana University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2022

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 7, 2024

Study Registration Dates

First Submitted

January 25, 2022

First Submitted That Met QC Criteria

February 22, 2022

First Posted (Actual)

February 25, 2022

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 17, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 12514

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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