Adding Nalbuphine for Control of Intrathecal Morphine Pruritus

Phase 2

• Conditions: Pruritus; Pain, Postoperative; Nausea, Postoperative; Vomiting, Postoperative
• Interventions: Drug: Morphine 10 MG/ML; Drug: Nalbuphine Hydrochloride 10 MG/ML

• Registration Number: NCT04589429
• Lead Sponsor: Minia University

Brief Summary

Intrathecal morphine causes intense itching which is very bothersome. Nalbuphine antagonizes this effect when given intravenously. This trial is to find out if nalbuphine added to intrathecal morphine has an effect on morphine related pruritus while still maintaining adequate analgesia.

Detailed Description

The study will be performed in MiniaUniversity Hospitals, after obtaining approval from the local ethics committee. All patients will have a peripheral IV cannula 18 G inserted; standard non-invasive monitors will be applied. Patients undergoing major abdominal surgery will be divided into 2 groups to receive intrathecal morphine 300 micrograms with or without nalbuphine 1mg prior to anesthesia. General anesthesia is then given to patients.

Study Timeline

• Study First Submitted: 2020-09-27
• Study First Submitted QC: 2020-10-09
• Study Start: 2020-10-15
• Study First Posted: 2020-10-19
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-26
• Primary Completion: 2021-03
• Study Completion: 2021-03
• Last Update Posted: 2021-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Male and female patients.
• Age 18-80yrs.
• Elective major abdominal surgery under general anesthesia.

Exclusion Criteria

• Refusal to participate.
• Skin or systemic disease with itching. Any condition which precludes performing spinal injection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MN group	Morphine 10 MG/ML	intrathecal morphine 300 micrograms+2mg nalbuphine
MN group	Nalbuphine Hydrochloride 10 MG/ML	intrathecal morphine 300 micrograms+2mg nalbuphine
M group	Morphine 10 MG/ML	intrathecal morphine 300 micrograms

Primary Outcome Measures

Name	Time	Method
pruritus	24 hours postoperatively	Pruritus score (1: no pruritus; 2: mild pruritus, treatment not requested; 3: moderate pruritus, treatment requested; 4: severe pruritus).

Secondary Outcome Measures

Name	Time	Method
postoperative nausea and vomiting	24 hours postoperative	four-point rating score (1: no nausea or vomiting, 2: queasy, 3: severe nausea, 4: vomiting
postoperative pain	24 hours postoperative	assessed with a verbal numeric pain score(NRS) where 0: no pain; 10: worst imaginable pain
Sedation	24 hours postoperative	four-point sedation score (1: fully awake; 2: somnolent, responds to call; 3: somnolent, responds to tactile stimulation; 4: asleep, responds to painful stimulation).

Trial Locations

Locations (1)

anesthesia&ICU department; 🇪🇬 Minya, Egypt