Ultrasound Guided : Retrolaminar Block Versus Thoracic Epidural Analgesia Following Laparoscopic Cholecystectomy
- Conditions
- Analgesia
- Interventions
- Procedure: Thoracic epidural analgesiaProcedure: Bilateral retrolaminar block
- Registration Number
- NCT04835415
- Lead Sponsor
- Zagazig University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description group T Thoracic epidural analgesia Group (T) (n=26): will receive ultrasound guided thoracic epidural analgesia: 20 ml of bupivacaine 0.25 % plus 5ug/ml adrenaline (1:200000). group R Bilateral retrolaminar block Group (R) (n=26): will receive bilateral ultrasound guided retrolaminar block analgesia: 20 ml of bupivacaine 0.25 % plus 5ug/ml adrenaline (1:200000).
- Primary Outcome Measures
Name Time Method Pain intensity at rest and at cough using Numerical Rating Scales (NRS) 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 Outcome Measures
Name Time Method Total analgesic (Naluphine) consumption within 12 hours postoperative Total consumption of rescue analgesia(Naluphine) post operative
Time to first call of rescue analgesia within 12 hours postoperative start from retrolaminar or epidural injection of the drug to the time of first call of naluphine
The number of participant with nausea, vomiting, hypotension and bradycardia. 24 hours postoperative the number of participant with nausea (sensation of being about to vomit), vomiting (the expelling of the food content from the stomach through mouth, it will be treated by 4 mg ondansetron), hypotension (if MAP decreases more than 20% of basal reading it will be treated by 12 mg ephedrine) and bradycardia (if HR less than 50 beats/min it will be treated by 0.5 mg atropine).
The number of participant with complications of the techinque (dural puncture , nerve injury, spinal injection, epidural haematoma, pleural puncture) within 24 hours postoperative The numer of participant with complications of the techinque (dural puncture , nerve injury, spinal injection, epidural haematoma, pleural puncture)
Patient satisfaction is recorded at the end of 24 hours postoperative 24 hours postoperative using 5-point Likert-like verbal rating scale by asking the patient about "how he/she evaluated their experience with the analgesic management after the surgery?"5=very satisfied, 4=satisfied, 3= neutral, 2= dissatisfied and 1= very dissatisfied".
Trial Locations
- Locations (1)
faculty of medicine, Zagazig university
🇪🇬Zagazig, Egypt