Adding Nalbuphine for Control of Intrathecal Morphine Pruritus

Does Adding Nalbuphine to Intrathecal Morphine Reduce Morphine Induced Pruritus? A Randomized, Double Blind, Controlled Study.

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.

Study Overview

• Status: Unknown
• Conditions: Pain, Postoperative; Pruritus; Nausea, Postoperative; Vomiting, Postoperative
• Intervention / Treatment: Drug: Morphine 10 MG/ML; Drug: Nalbuphine Hydrochloride 10 MG/ML

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 Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Minya, Egypt
    • Recruiting
    • anesthesia&ICU department
    • Contact: Sohair A Megalla, MD; Phone Number: 01200036447; Email: Sohair.Adeeb@minia.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: MN group; intrathecal morphine 300 micrograms+2mg nalbuphine	Drug: Morphine 10 MG/ML; intrathecal morphine 300 micrograms; Other Names: morphine; Drug: Nalbuphine Hydrochloride 10 MG/ML; intrathecal nalbuphine 2mg.; Other Names: nalbuphine
PLACEBO_COMPARATOR: M group; intrathecal morphine 300 micrograms	Drug: Morphine 10 MG/ML; intrathecal morphine 300 micrograms; Other Names: morphine

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Minia University
• Investigators: Principal Investigator: Sohair A Megalla, MD, Anesthesia and ICU department, Faculty of Medicine, Minia University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 15, 2020
• Primary Completion (ANTICIPATED): March 1, 2021
• Study Completion (ANTICIPATED): March 1, 2021

Study Registration Dates

• First Submitted: September 27, 2020
• First Submitted That Met QC Criteria: October 9, 2020
• First Posted (ACTUAL): October 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 1, 2021
• Last Update Submitted That Met QC Criteria: February 26, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: pruritus; intrathecal nalbuphine; intrathecal morphine
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Skin Manifestations; Nausea; Pain, Postoperative; Vomiting; Pruritus; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine; Nalbuphine
• Other Study ID Numbers: 678-9/2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No