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To study the efficacy of an oral drug tapentadol on duration of spinal anaesthesia and additional pain sparing effect after lower limb orthopaedic surgery

Efficacy of oral Tapentadol on duration of spinal anaesthesia and post-operative pain after lower limb orthopaedic surgery.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/08/035497
Enrollment
70
Registered
2021-08-06
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Group D: Drug Group - Oral Drug Tapentadol: Patient will be given one tablet of tapentadol 75mg orally with a sip of water 1hr prior to surgery. Control Intervention1: Group C: Control

Sponsors

Department Of Anaesthesia and Intensive Care
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: American society of Anaesthesiologists (ASA) physical status I and II of either sex. BMI >= 20 to Duration of surgery 2-3 hours (i.e fracture shaft femur, fracture tibia, fracture ankle)

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Preemptive role of drug Tapentadol on the duration of spinal anaesthesia(Sensory and motor blockade)Timepoint: Just after giving spinal anaesthesia sensory block checked by pin prick method and motor 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

MeasureTime frame
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. Timepoint: 4,8,12,24 hours post operatively

Countries

India

Contacts

Public ContactDr Jasveer Singh

Government Medical College and Hospital ,Chandigarh

drjassy18@gmail.com9646121664

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026