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Clinical Trials/NCT04835415
NCT04835415
Completed
Not Applicable

Ultrasound Guided : Retrolaminar Block Versus Thoracic Epidural Analgesia for Pain Control Following Laparoscopic Cholecystectomy

Zagazig University1 site in 1 country52 target enrollmentApril 10, 2021
ConditionsAnalgesia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Analgesia
Sponsor
Zagazig University
Enrollment
52
Locations
1
Primary Endpoint
Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The aim of this study is to evaluate analgesic effect of ultrasound-guided retrolaminar block vs ultrasound-guided thoracic epidural analgesia in pain control following laparoscopic cholecystectomy.

Detailed Description

To study the difference between the effects of ultrasound-guided bilateral retrolaminar block and ultrasound-guided thoracic epidural analgesia on pain control following laparoscopic cholecystectomy. To relief pain and improve satisfaction in patients undergoing laparoscopic cholecystectomy at Zagazig university hospitals.

Registry
clinicaltrials.gov
Start Date
April 10, 2021
End Date
December 1, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dina Abdelhameed Elsadek Salem

Principle investigator

Zagazig University

Eligibility Criteria

Inclusion Criteria

  • Written informed consent from the patient.
  • Age: 21-45 years old.
  • Sex: both sex (males and females).
  • Physical status: ASA 1\& II.
  • BMI = (25-35 kg/m2).
  • Type of operation: elective laparoscopic cholecystectomy

Exclusion Criteria

  • Altered mental state.
  • Patients with known history of allergy to study drugs.
  • Advanced hepatic, renal, cardiovascular, and respiratory diseases.
  • Patients with chronic pain.
  • Patients receiving anticoagulants.
  • Contraindications of regional anesthesia, e.g., allergy to local anesthetics, coagulopathy, or septic focus at site of injection.

Outcomes

Primary Outcomes

Pain intensity at rest and at cough using Numerical Rating Scales (NRS)

Time Frame: at 12 hours postoperative

measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)

Secondary Outcomes

  • Total analgesic (Naluphine) consumption(within 12 hours postoperative)
  • Time to first call of rescue analgesia(within 12 hours postoperative)
  • The number of participant with nausea, vomiting, hypotension and bradycardia.(24 hours postoperative)
  • The number of participant with complications of the techinque (dural puncture , nerve injury, spinal injection, epidural haematoma, pleural puncture)(within 24 hours postoperative)
  • Patient satisfaction is recorded at the end of 24 hours postoperative(24 hours postoperative)

Study Sites (1)

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