Two drugs will be compared along with local anaesthetics in spinal anaesthesia.

Phase 3

Not yet recruiting

• Conditions: Acquired deformity of musculoskeletal system, unspecified,

• Registration Number: CTRI/2021/01/030252
• Lead Sponsor: Subhaprada satapathy

Brief Summary

Post operative pain control is a major concern because spinal anaesthesia using only local anaesthetics is associated with relatively shorter duration of action and thus early analgesic intervention is needed in post-operative period. There are very few studies which have compared efficacy of intrathecal Fentanyl and Nalbuphine as adjuvants to hyperbaric Bupivacaine in lower limb surgeries,therefore this present study is planned with the aim of comparing the analgesic effect & duration of analgesia provided by intathecal Fentanyl and Nalbuphine.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-05-01
• Study Start: 2021-12-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1.Adults in the age group of 18-65 years 2.ASA I or II 3.Elective lower limb surgeries.

Exclusion Criteria

• 1.Body mass index ≥30.
• 2.Height less than 155 cm.
• 3.Contraindications to spinal anaesthesia(patient refusal,coagulation disorder, infection at puncture site,increased intracranial tension, haemodynamic instability, spinal deformities,known history of allergy to the study drugs).
• 4.Patients on hypnotics,antipsychotics,tranquilizers or other CNS depressants.
• 5.Patients with history of adverse reaction to opioids.
• 6.Pregnancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the duration of effective analgesia between the two drugs(time from intrathecal injection till the requirement of first rescue analgesic)	1.5years

Secondary Outcome Measures

Name	Time	Method
1.Intraoperative haemodynamic parameters.	2.Post operative VAS

Trial Locations

Locations (1)

Kalinga Institute of Medical Sciences; 🇮🇳 Khordha, ORISSA, India

Kalinga Institute of Medical Sciences

🇮🇳Khordha, ORISSA, India

Subhaprada Satapathy

Principal investigator

8093627227

subhaprada1995@gmail.com