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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04845711
Other study ID # 34503/2/21
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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