Comparison of the postoperative analgesic efficacy of Levobupivacaine alone and with Dexamethasone in ultrasound guided Quadratus Lumbor
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- 1. To compare the duration of analgesia.
Study Overview
Brief Summary
This is a prospective randomised double blind study. Institutional ethical committee clearance obtained and informed consent would be taken from the patient. The total of 90 patients between the age 18 to 60 years of ASA grade 1 and 2 undergoing unilateral inguinal hernioplasty would be randomly divided into 2 groups of 45 each. After surgery under spinal anaesthesia, Group L will receive 0.25 % Levobupivane 20 ml + 1 ml 0.9 % normal saline and Group D will receive 0.25% 20 ml Levobupivacaine + 1 ml Dexamethasone (4 mg/ml) with a total of 21 ml in each group in ultrasound guided type 1 (lateral) Quadratus Lumborum block. Postoperatively, we will record and compare the duration of analgesia, total rescue analgesic (Tramadol) requirements and NRS pain scores in first 24 hours.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Age group of 18 –60 years of both sexes
- •ASA grade I and II
- •Weight 50-90 kg
- •Patients scheduled for elective unilateral inguinal hernia repair.
Exclusion Criteria
- •Patient’s or relative’s refusal
- •Known hypersensitivity to local anesthetics
- •Opioid addict
- •Any chronic systemic illness
- •Bleeding diathesis
- •Severe stenotic heart diseases
- •Anatomical abnormality
- •Any infection at the regional site
- •Pregnant women
- •Pre existing peripheral neuropathy or neurological deficits.
Outcomes
Primary Outcomes
1. To compare the duration of analgesia.
Time Frame: 24 hours
2. To compare post operative rescue analgesic requirement in first 24 hours.
Time Frame: 24 hours
3. Post-operative NRS ( Numerical Rating Scale ) scores.
Time Frame: 24 hours
Secondary Outcomes
- 1. To compare the hemodynamic and respiratory parameters.(2. Any side effects or complications of study drugs and block.)