Bilateral vs. Unilateral Erector Spinae Plane Block

Bilateral vs. Unilateral Erector Spinae Plane Block for Laparoscopic Cholecystectomy; A Randomised Controlled Trial

The importance of multimodal analgesia for postoperative pain management is well known and regional anesthesia techniques are commonly prefferred to provide better analgesia. Erector spinae plane block (ESB) is a new defined and effective regional anesthesia technique. But two injections can be unconfortable for some patients. With this study, we aimed to compare the analgesia effect of bilateral and unilateral ESP block for laparoscopic cholecystectomy.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Cholecystitis; Gallstone
• Intervention / Treatment: Procedure: Bilateral ESP Block; Device: Intravenous Morphine patient controlled analgesia device; Procedure: Unilateral ESP Block

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kocaeli
    • İzmit, Kocaeli, Turkey, 41340
      • Kocaeli University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA I-II patients
• Pateints undergoing elective laparoscopic cholecystectomy

Exclusion Criteria:

• obesity (body mass index >35 kg/m2)
• infection of the skin at the site of needle puncture area
• patients with known allergies to any of the study drugs
• coagulopathy
• recent use of analgesic drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bilateral; Bilateral ESP block will be performed	Procedure: Bilateral ESP Block; Bilateral ESP Block will be performed at T8; Device: Intravenous Morphine patient controlled analgesia device; 24 hour morphine consumption will be recorded
Active Comparator: Unilateral; Unilateral ESP block will be performed	Device: Intravenous Morphine patient controlled analgesia device; 24 hour morphine consumption will be recorded; Procedure: Unilateral ESP Block; Unilateral ESP Block will be performed at T8 (right side)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine consumption	Morphine consumption will be recorded	preoperative 24th hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Rating Scale	A NRS involves asking the patient to rate his or her pain from 0 to 10 (11 point scale) with the understanding that 0 is equal to no pain and 10 is equal to worst possible pain.	postoperative 24th hour

Collaborators and Investigators

• Sponsor: Kocaeli University
• Investigators: Principal Investigator: Can Aksu, Kocaeli Üniversitesi Tıp Fakültesi

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2019
• Primary Completion (Actual): June 28, 2019
• Study Completion (Actual): June 29, 2019

Study Registration Dates

• First Submitted: December 18, 2018
• First Submitted That Met QC Criteria: December 18, 2018
• First Posted (Actual): December 20, 2018

Study Record Updates

• Last Update Posted (Actual): November 25, 2019
• Last Update Submitted That Met QC Criteria: November 21, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: postoperative pain; laparoscopic cholecystectomy; erector spinae plane block
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Calculi; Cholelithiasis; Cholecystolithiasis; Pain, Postoperative; Cholecystitis; Gallstones; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: KIA 2018/488

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: No
• Studies a U.S. FDA-regulated device product: No