To see which mode of administration of Injection nalbuphine is more effective in preventing itching caused by painkiller morphine

Phase 4

Not yet recruiting

• Conditions: Undergoing orthopedic surgeries under spinal anaesthesia

• Registration Number: CTRI/2017/04/008332
• Lead Sponsor: Shri Sathya Sai Medical College and Research Institute

Brief Summary

Intrathecal morphine gives intense postoperative pain relief but is known to cause adverse effects like pruritus and respiratory depression. respiratory depression is uncommon at low doses but incidence of pruritus is 30-100%. Exact mechanism of intrathecal morphine induced pruritus is not known and many therapies are tried with limited success. Spinal kappa receptors can supress itch and hence drugs acting on them like nalbuphine can be effective.Previous studies have proved efficacy of intavenous nalbuphine over other agents in treating opioid induced pruritus without affecting analgesia and sedation. However studies proving efficacy of intrathecal nalbuphine for morphine induced pruritus are not available.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-05
• Last Update Posted: 2017-05-04

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1.Willingness to participate in the study 2.ASA 1 or 2 physical status 3.Orthopaedic procedures under subarachnoid block.

Exclusion Criteria

1.ASA 3 and above 2.Psychiatric illness 3.Patients on anticoagulants 4Impaired renal or hepatic function 5.Major cardiac disease 6.Allergic to local anesthetic 7.Pre-existing dermatological conditions causing pruritus at the time of surgery 8.Already on opioid or poor resp reserve.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of pruritus between interventional and comparator group	every 4 hourly for 24 hours.

Secondary Outcome Measures

Name	Time	Method
To compare severity of pruritus,	analgesia, incidence of nausea vomiting and respiratory depression, intraoperative hemodynamic stability, sensory level

Trial Locations

Locations (1)

Shri Sathya Sai Medical College and esearch Institute, Ammapettai; 🇮🇳 Kancheepuram, TAMIL NADU, India

Shri Sathya Sai Medical College and esearch Institute, Ammapettai

🇮🇳Kancheepuram, TAMIL NADU, India

Dr Pranjali Kurhekar

Principal investigator

9486414942

pranjalikurhekar@gmail.com