ESP Block VS Intrathecal Opioid After Laparoscopic Colorectal Surgery

Indiana University

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Surgery

Treatments: Drug: IT Injection; Drug: ESP Block

Study type: Interventional

Funder types: Other

Identifiers

NCT05257941

12514

Details and patient eligibility

About

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.

Enrollment: 116 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 2 patient groups

IT Injection

Active Comparator group

Description:

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

Treatment:

Drug: IT Injection

ESP Block

Active Comparator group

Description:

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

Treatment:

Drug: ESP Block