FindTrial
Sign In

a clinical trial to study the effects of two pain relief drugs,nalbuphine and butorphanol added to ropivacaine ,a numbing drug injected at the lower back into a space that carries nerves in patients undergoing lower extremity broken bone surgeries.

A Randomised double blind control study of the analgesic efficacy of intrathecal nalbuphine and butorphanol as adjuvants to isobaric 0.5% Ropivacaine in lower limb orthopaedic surgeries.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/05/033578
Enrollment
120
Registered
2021-05-12
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: PCS- Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: nalbuphine as additive to intrathecal ropivacaine: 0.5mg of nalbuphine(0.5ml) as additive to intrathecal 0.5% isobaric ropivacaine(2.5ml) for patients undergoing lower limb orthopaedic

Sponsors

Melmaruvathur Adhiparasakthi institute of Medical Sciences and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age 18-60 years Both gender American Society of anaesthesiologists(ASA) physical status I and II Patients undergoing lower limb orthopaedic surgeries under subarachnoid block. BMI

Exclusion criteria

Exclusion criteria: Patient refusal ASA 3 and 4 Patients with local infection at the site of injection . Patients with known or ascertained hypersensitivity to local anaesthetics. Patient with coagulopathy, bleeding disorders and/or on treatment with anti-coagulants. Spinal deformities. - Pregnant women and lactating women - Other contraindications for spinal anaesthesia

Design outcomes

Primary

MeasureTime frame
postoperative analgesia using VAS pain scaleTimepoint: postoperative period-2nd 4th 6th 8th 12th 16th 20th and 24th hours—

Secondary

MeasureTime frame
Hemodynamic parameters(Heart rate,Mean arterial pressure,Oxygen saturation)Timepoint: baseline,2minutes,4minutes,6minutes,8minutes,10minutes,15minutes,30minutes,45minutes 1hour,1.5hours,2hours,4hours,6hours,8hours,10hours,12hours,16hours,20hours,24hours ;Return to bromage score zeroTimepoint: postoperative period upto 4hours;time to voidTimepoint: postoperative period upto 24hours—

Countries

India

Contacts

Public ContactDr A Ilakya

Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research

lingamjks@gmail.com8144008182

Outcome results

None listed

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