Clinical trial NCT04835415: Ultrasound Guided : Retrolaminar Block Versus Thoracic Epidural Analgesia Following Laparoscopic Cholecystectomy
Official title: Ultrasound Guided : Retrolaminar Block Versus Thoracic Epidural Analgesia for Pain Control Following Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Keywords: Ultrasound
Bilateral retrolaminar
Thoracic epidural
post operative analgesia
Laparoscopic cholecystectomy
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2021-04-08
Enrollment: 52
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Analgesia for postoperative pain after laparoscopic cholecystectomy by using ultrasound-guided retrolaminar block vs ultrasound-guided thoracic epidural analgesia.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
timeFrame: 30 minutes postoperative
measure: Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
timeFrame: at 1 hour postoperative
measure: Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
timeFrame: at 2 hours postoperative
measure: Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
timeFrame: at 4 hours postoperative
measure: Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
timeFrame: at 6 hours postoperative
measure: Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
timeFrame: at 8 hours postoperative
measure: Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
timeFrame: at 10 hours postoperative
measure: Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
timeFrame: at 12 hours postoperative
Secondary outcomes:
measure: Time to first call of rescue analgesia
timeFrame: within 12 hours postoperative
measure: Total analgesic (Naluphine) consumption
timeFrame: within 12 hours postoperative
measure: The number of participant with complications of the techinque (dural puncture , nerve injury, spinal injection, epidural haematoma, pleural puncture)
timeFrame: within 24 hours postoperative
measure: Patient satisfaction is recorded at the end of 24 hours postoperative
timeFrame: 24 hours postoperative
measure: The number of participant with nausea, vomiting, hypotension and bradycardia.
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: faculty of medicine, Zagazig university
Study officials:
affiliation: faculty of medicine , Zagazig University
name: Dina Salem, MD.
role: PRINCIPAL_INVESTIGATOR
References: