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ESP Block VS Intrathecal Opioid After Laparoscopic Colorectal Surgery

Sponsor
Indiana University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05257941
Collaborator
(none)
126
Enrollment
1
Location
2
Arms
34.1
Anticipated Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: IT Injection
  • Drug: ESP Block
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
126 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 27, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. cumulated oral morphine equivalent (OME) [24 hours after surgery]

    morphine consumption

Secondary Outcome Measures

  1. opioid consumption [1 hour after surgery]

    opioid consumption in OME

  2. opioid consumption [12 hours after surgery]

    opioid consumption in OME

  3. opioid consumption [24 hours after surgery]

    opioid consumption in OME

  4. opioid consumption [48 hours after surgery]

    opioid consumption in OME

  5. opioid consumption [72 hours after surgery]

    opioid consumption in OME

  6. Visual Analog Scale pain scores [1 hour after surgery]

    pain scores using the Visual Analog Scale (0-10 with 0 being no pain and 10 being the worst pain)

  7. Visual Analog Scale pain scores [12 hours after surgery]

    pain scores using the Visual Analog Scale (0-10 with 0 being no pain and 10 being the worst pain)

  8. Visual Analog Scale pain scores [24 hours after surgery]

    pain scores using the Visual Analog Scale (0-10 with 0 being no pain and 10 being the worst pain)

  9. Visual Analog Scale pain scores [48 hours after surgery]

    pain scores using the Visual Analog Scale (0-10 with 0 being no pain and 10 being the worst pain)

  10. Visual Analog Scale pain scores [72 hours after surgery]

    pain scores using the Visual Analog Scale (0-10 with 0 being no pain and 10 being the worst pain)

  11. opioid side effects [duration of hospital stay up to 72 hours]

    incidence of opioid side effects (nausea, pruritus, urinary retention, respiratory depression, ileus)

  12. first ambulation [duration of hospital stay up to 72 hours]

    time to patient first ambulation

  13. first flatus [duration of hospital stay up to 72 hours]

    time to first flatus

  14. oral liquid [duration of hospital stay up to 72 hours]

    time to first oral liquid intake

  15. oral food [duration of hospital stay up to 72 hours]

    time to first oral food intake

  16. hospital stay [duration of hospital stay up to 7 days]

    amount of time each subject spends in the hospital before discharge

  17. patient's satisfaction scores [24 hours after surgery]

    assess patient's satisfaction with care (1-10 with 1 being the least satisfied and 10 being the most satisfied)

  18. patient's satisfaction scores [48 hours after surgery]

    assess patient's satisfaction with care (1-10 with 1 being the least satisfied and 10 being the most satisfied)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 IU Health University Hospital Indianapolis Indiana United States 46202

Sponsors and Collaborators

  • Indiana University

Investigators

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

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Amy McCutchan, Assistant Professor of Clinical Anesthesiology, Indiana University
ClinicalTrials.gov Identifier:
NCT05257941
Other Study ID Numbers:
  • 12514
First Posted:
Feb 25, 2022
Last Update Posted:
Feb 25, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 25, 2022