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

A comparative study of Intrathecal Fentanyl and Nalbuphine as an adjuvant to hyperbaric Bupivacaine for spinal anaesthesia in lower limb orthopaedic surgeries:A prospective double blinded randomized control study

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/01/030252

Enrollment

100

Registered

2021-01-05

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: - Health Condition 2: M959- Acquired deformity of musculoskeletal system, unspecified

Interventions

Intervention1: Subarachnoid block: Adjuvants along with hyperbaric bupivacaine will be given intrathecally in lower limb orthopaedic surgeries for post op pain managaement in patients. In Group BF(Bup

Eligibility

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
To compare the duration of effective analgesia between the two drugs(time from intrathecal injection till the requirement of first rescue analgesic)Timepoint: 1.5years	—

Secondary

Measure	Time frame
1.Intraoperative haemodynamic parameters. 2.Post operative VAS 3.Incidence of side effects like sedation, pruritus, nausea, vomiting. Timepoint: 1.5years	—

Countries

India

Contacts

Public ContactDr Ganesh chandra Satapathy

KALINGA INSTITUTE OF MEDICAL SCIENCES,BBSR

ganesh.satapathy@kims.ac.in8283872939

Outcome results

None listed

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