Perioperative Opioid-sparing Effect of Retrosuperior Costotransverse Ligament Block Versus Erector Spinae Block in Laparoscopic Cholecystectomy: A Randomized Clinical Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Zagazig University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- The time to first call to rescue analgesia
Study Overview
Brief Summary
This study aims to compare the analgesic effect of retro superior costotransverse ligament space block vs erector spinae plane block to Achieve high-quality perioperative opioid-sparing effect and postoperative analgesia after laparoscopic cholecystectomy with optimum hemodynamic stability and high patient and surgeon satisfaction
Detailed Description
This study aims to compare between retro superior costotransverse ligament space block vs erector spinae plane block
- To compare the analgesic outcomes (time to first analgesic request, total amount of analgesic consumption and pain scores by NRS)
- To assess the block performance time required to perform each technique .
- To compare intraoperative parameters (hemodynamics and intraoperative fentanyl consumption)
- To assess patient, surgeon satisfaction and complications of the block.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
anesthesiologist not sharing in the study will assess outcomes
Eligibility Criteria
- Ages
- 21 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •patient acceptance
- •Age: 21-64 years old.
- •Sex: both sexes.
- •Physical status: ASA I & II.
- •Body mass index (BMI): 18.5 - 30 kg/m
- •Type of operations: elective laparoscopic cholecystectomy.
- •Duration of surgery not more than 2 hours.
Exclusion Criteria
- •Known hypersensitivity to lidocaine or bupivacaine.
- •Patients with respiratory insufficiency.
- •Coagulation disorders or taking drugs affect surgical hemostasis.
- •7. Patients with pre-existing neurological deficits.
- •Uncooperative patient or with altered mental status.
- •Patient with advanced cardiovascular or respiratory diseases
Outcomes
Primary Outcomes
The time to first call to rescue analgesia
Time Frame: 24 hours
The time to first call to rescue analgesia( the interval between the block injection till the NRS more than or equal 4) (naluphine) will be recorded
Secondary Outcomes
- To assess block characteristics (block performance time)(1 hour)
- Total intraoperative fentanyl consumption(duration of surgery (up to 2 hours))
- Pain intensity by Numerical Rating Scale(30 minutes after arrival to post anesthesia care unit , 2hours, 4hours, 6hours, 8hours, 12hours, 18 hours and 24hours postoperative)
- total amount of rescue analgesia(24 hours)
- Intraoperative hemodynamics (Heart Rate and Mean Arterial Pressure)(every 5 minutes in the first 30 minutes then every 10 minutes till the end of surgery)
- Patient's satisfaction(24 hours)
- complication of the block(24 hours)
Investigators
Dina Abdelhameed Elsadek Salem
Associate professor
Zagazig University