NCT05257941

ESP Block VS Intrathecal Opioid After Laparoscopic Colorectal Surgery

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

All laparoscopic colorectal cases were scheduled by colorectal surgeons at IU Health University or Methodist Hospital and were identified using medical records. The subjects were contacted face-to-face prior to surgery. They were informed about the study and questions were answered. The potential subjects were given a copy of the informed consent form and authorization form. The subjects were contacted face-to-face in Pre-Operative Care Unit on the day of surgery and if they decided to participate, written consent was taken. In the Intrathecal group, intrathecal preservative free morphine (duramorph) 200 mcg with 7.5mg of hyperbaric bupivacaine was given for a patient 18-75 years of age and duramorph 150 mcg with 7.5mg of hyperbaric bupivacaine was given for a patient 76- 80 years of age. In the ESP group, a patient was given a bilateral ESP block at thoracic vertebrae level 10 (T10). This was placed under ultrasound using 30 ml of 0.25% bupivacaine and 4 mg of Decadron. Randomization will be performed using Research Randomizer. The primary investigator informed the person doing the regional techniques as to what group the patients were randomized to. Neither the patients and the research staff doing assessments will be blinded to the randomization.

Conditions

• Surgery

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2022-01-27
• Primary completion: 2024-08-26
• Completion: 2024-08-29
• First posted: 2022-02-25
• Last updated: 2026-03-02
• Results posted: 2026-03-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study