Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block in Laparoscopic Cholecystectomy

Laparoscopic Cholecystectomy Clinical Trial

Official title:

Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Laparoscopic Cholecystectomy Surgeries: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04845711
• Other study ID #: 34503/2/21
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: November 1, 2021

Study information

• Verified date: April 2021
• Source: Tanta University
• Contact: Mai E Hamada, MBBCH
• Phone: 00201285851295
• Email: mai154450_pg[@]med.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare between the efficacy of ultrasound guided erector spinae plane block and ultrasound guided quadratus lumborum block in managing acute postoperative pain in patients undergoing laparoscopic cholecystectomy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: November 1, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• aged 21-65 years

• both genders

• American Society of Anesthesiology (ASA) class I-II

• Undergoing elective laparoscopic cholecystectomy

Exclusion Criteria:

• Patient refusal.

• Coagulopathy.

• History of allergy to local anaesthetic.

• History of liver or renal pathology affecting drug elimination

• Mental dysfunction or cognitive disorders.

• Use of medication such as gabapentin-pregabalin that could affect pain perception.

• Body Mass Index > 40 kg/m2.

Related Conditions & MeSH terms

• Erector Spinae Plane Block
• Laparoscopic Cholecystectomy
• Postoperative Analgesia
• Quadratus Lumborum Block

Intervention

Other:
• Control group
patients will receive general anesthesia only.

Procedure:
• Erector spinae plane block group
patients will receive general anesthesia and bilateral ultrasound guided erector spinae plane block (20ml Bupivacaine 0.25%)
• Quadratus lumborum block group
patients will receive general anesthesia and bilateral ultrasound guided quadratus lumborum block (20 ml Bupivacaine 0.25%)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The degree of postoperative pain in the first 24 hours post-operative	Postoperative pain will be assessed by the numerical rating scale (NRS); 0 no pain while 10 is the maximum pain) after discharge to the ward ,and at 6, 12, 18, 24 hours.	first 24 hours post-operative
Secondary	Time to first analgesic requirement	Intravenous morphine 2 mg will be given when the numerical rating scale (NRS) equal or above 4	first 24 hours post-operative
Secondary	Total dose of intraoperative consumption of fentanyl	Fentanyl 0.5 µg/kg will be given if there was increase in heart rate or mean arterial blood pressure more than 20% (after exclusion of other causes than pain).	intraoperative
Secondary	Total dose of rescue analgesia in the first 24hr postoperative	Total morphine consumption 24 hours after surgery will be recorded. Intravenous morphine 2 mg will be given when the numerical rating scale (NRS) equal or above 4	first 24 hours post-operative