Incidence of pruritus after intrathecal administration of Fentanyl.

Not yet recruiting

• Conditions: Other disturbances of skin sensation,

• Registration Number: CTRI/2019/01/016944
• Lead Sponsor: MGM Medical college And Hospital

Brief Summary

Patients to be posted for lower limb orthopaedic surgeries under spinal anaesthesia will be included in the study. After informed consent, spinal anaesthesia will be given in L3-4 intervertebral space in sitting position. Hyperbaric Bupivacaine (10 - 15 mg) and Fentanyl (25 mcg) will be injected intrathecally.

After administration of intrathecal fentanyl, occurence and severity of pruritus will be assessed. Severity of pruritus will be scored from 0-2 (where 0 = no pruritus, 1 = mild to moderate pruritus requiring no treatment, 2 = severe pruritus requiring treatment) at 30 min, 1 hour, 2 hour, 4 hour and 6 hour. Site of pruritus will also be documented.

In case of severe pruritus, Inj. Nalbuphine 2 - 3 mg will be given IV. If no response then Inj. Naloxone 0.1 - 0.2 mg will be given.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-15
• Last Update Posted: 2019-05-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

Patients receiving spinal anaesthesia using local anaesthetics & Fentanyl for lower limb orthopaedic surgeries.

Exclusion Criteria

1)Patients having skin disease with pruritus 2)Patients having systemic disease with pruritus 3)Patient receiving antihistaminics or steroids 4)Patients with Opioid dependency 5)Patients with Psychiatric disorders.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of pruritus	Intraoperative and postoperative for 6 hours

Secondary Outcome Measures

Name	Time	Method
severity of pruritus	at 30 min., 1 hour, 2 hour, 4 hour and 6 hour after administration of intrathecal fentanyl

Trial Locations

Locations (1)

MGM medical college and hospital; 🇮🇳 Aurangabad, MAHARASHTRA, India

MGM medical college and hospital

🇮🇳Aurangabad, MAHARASHTRA, India

Dr S J Kulkarni

Principal investigator

9881300645

drsanhitakulkarni@gmail.com