Efficacy of ultrasound guided erector spinae plane block with or without dexmedetomidine on the postoperative analgesia in patients undergoing laparoscopic cholecystectomy -A comparative study
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Dr Brahmacharimayum Diparani Devi
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- 1.Duration of analgesia (hours)
Overview
Brief Summary
Postoperative pain control is a substantial problem with laparoscopic cholecystectomy ,a common surgical procedure.Erector spinae plane block (ESPB), a relatively new block has been shown to have beneficial effects on post operative analgesia in neuropathic pain , thoracic surgical procedures and upper abdominal surgeries.
The aim of this prospective randomized double blinded study is to compare the efficacy of ESPB with local anaesthetic 0.375 % ropivacaine with or without dexmedetomidine as an adjuvant in laparoscopic surgeries.
A total of 60 patients scheduled to undergo laparoscopic cholecystectomy will be enrolled in the study and divided into two groups .According to a computer-generated randommization table, patients in group A will receive ESPB with only local anaesthetic,while those in group B will receive ESPB with local anaesthetic admixed with dexmedetomidine 0.5 microgram per kg.The data will collected,entered in the master chart, and analysed using the student’s ’t ’ test for continuous data and the chi-square test for categorical data,,as and where appropriate.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •a.Patients of either gender, b.
- •American Society of Anaesthesiologists (ASA) physical status I or II , c.
- •Age 18-60 years d.
- •BMI (Body mass index): 18-25kg/m.
Exclusion Criteria
- •a.Patient refusal and allergic to study drugs (local anaesthetics) b.
- •Bleeding disorder-platelet count less than 50,000/microlitre, prothrombin time more than 14 sec and International normalised ratio (INR) more than 1.5 c.
- •Local site infection and with neurological deficits of lower limb and torso d.
- •Cardiac, respiratory diseases, kidney disorders, pregnancy and spinal deformity and mental/cognitive impairment.
Outcomes
Primary Outcomes
1.Duration of analgesia (hours)
Time Frame: Outcomes will be recorded at 0,6,12, and 24 hours. Data collected will be assessed at the end of one year
2.Time to first rescue analgesic
Time Frame: Outcomes will be recorded at 0,6,12, and 24 hours. Data collected will be assessed at the end of one year
3.Total dose of rescue analgesics consumed in first 24 hours
Time Frame: Outcomes will be recorded at 0,6,12, and 24 hours. Data collected will be assessed at the end of one year
4.Pain score using Visual analogue scale (VAS) at 0,6,12, 24 hours
Time Frame: Outcomes will be recorded at 0,6,12, and 24 hours. Data collected will be assessed at the end of one year
(postoperative)
Time Frame: Outcomes will be recorded at 0,6,12, and 24 hours. Data collected will be assessed at the end of one year
Secondary Outcomes
- 1.Hemodynamic profile- pulse rate, systolic blood pressure (SBP), diastolic(blood pressure (DBP), mean arterial pressure (MAP))
Investigators
Dr Brahmacharimayum Diparani Devi
Regional Institute of Medical Sciences Imphal West