Bilateral vs. Unilateral Erector Spinae Plane Block

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03781687
• Other study ID #: KIA 2018/488
• Status: Completed
• Phase: N/A
• Start date: January 2, 2019
• Est. completion date: June 29, 2019

Study information

• Verified date: November 2019
• Source: Kocaeli University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 29, 2019
• Est. primary completion date: June 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholecystitis
• Cholecystitis; Gallstone
• Gallstones
• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Bilateral ESP Block
Bilateral ESP Block will be performed at T8
• Unilateral ESP Block
Unilateral ESP Block will be performed at T8 (right side)

Device:
• Intravenous Morphine patient controlled analgesia device
24 hour morphine consumption will be recorded

Locations

Country	Name	City	State
Turkey	Kocaeli University Hospital	Izmit	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine consumption	Morphine consumption will be recorded	preoperative 24th hour
Secondary	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