To study the efficacy of an oral drug tapentadol on duration of spinal anaesthesia and additional pain sparing effect after lower limb orthopaedic surgery
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2021/08/035497
- Lead Sponsor
- Department Of Anaesthesia and Intensive Care
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
American society of Anaesthesiologists (ASA) physical status I and II of either sex.
BMI >= 20 to <= 35 kg m2
Duration of surgery 2-3 hours (i.e fracture shaft femur, fracture tibia, fracture ankle)
Pre-existing local infection at the site of spinal block.
Patients with coagulopathy and bleeding disorders
Contraindication or allergy to opioids.
Patients having pain in any other area other than surgery site
Patient having sensory or motor problem in the lower limb
Patients who failed to understand VAS scoring system.
Pregnant and lactating women
Patients with current history of psychiatric illness, communication difficulties
Patient on any psychotropic drugs, alpha 2 agonists or opioids medications within 28 days before scheduled surgery.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Preemptive role of drug Tapentadol on the duration of spinal anaesthesia(Sensory and motor blockade)Timepoint: Just after giving spinal anaesthesia sensory <br/ ><br>block checked by pin prick method and motor <br/ ><br>block by modified bromage score.Sensory and motor blockade will be assessed every minute for the first 10 minutes and thereafter every 10 mins during surgery and every 15 minutes, postoperatively.
- Secondary Outcome Measures
Name Time Method onset of sensory and motor block, duration of motor block, time to first rescue analgesia, VAS score, Ramsay sedation score, cumulative opioid consumption during first 24 hours and any side effects. <br/ ><br>Timepoint: 4,8,12,24 hours post operatively