Adding Nalbuphine for Control of Intrathecal Morphine Pruritus

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04589429
• Other study ID #: 678-9/2020
• Status: Recruiting
• Phase: Phase 2
• Start date: October 15, 2020
• Est. completion date: March 2021

Study information

• Verified date: February 2021
• Source: Minia University
• Contact: Sohair A Megalla, MD
• Phone: +20 120 003 6447
• Email: Sohair.Adeeb[@]minia.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Nausea, Postoperative
• Pain, Postoperative
• Postoperative Nausea and Vomiting
• Pruritus
• Vomiting
• Vomiting, Postoperative

Intervention

Drug:
• Morphine 10 MG/ML
intrathecal morphine 300 micrograms
• Nalbuphine Hydrochloride 10 MG/ML
intrathecal nalbuphine 2mg.

Locations

Country	Name	City	State
Egypt	anesthesia&ICU department	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pruritus	Pruritus score (1: no pruritus; 2: mild pruritus, treatment not requested; 3: moderate pruritus, treatment requested; 4: severe pruritus).	2 hours postoperatively
Primary	pruritus	Pruritus score (1: no pruritus; 2: mild pruritus, treatment not requested; 3: moderate pruritus, treatment requested; 4: severe pruritus).	4 hours postoperatively
Primary	pruritus	Pruritus score (1: no pruritus; 2: mild pruritus, treatment not requested; 3: moderate pruritus, treatment requested; 4: severe pruritus).	24 hours postoperatively
Secondary	postoperative pain	assessed with a verbal numeric pain score(NRS) where 0: no pain; 10: worst imaginable pain	2 hours postoperative
Secondary	postoperative pain	assessed with a verbal numeric pain score(NRS) where 0: no pain; 10: worst imaginable pain	4 hours postoperative
Secondary	postoperative pain	assessed with a verbal numeric pain score(NRS) where 0: no pain; 10: worst imaginable pain	24 hours postoperative
Secondary	postoperative nausea and vomiting	four-point rating score (1: no nausea or vomiting, 2: queasy, 3: severe nausea, 4: vomiting	2 hours postoperative
Secondary	postoperative nausea and vomiting	four-point rating score (1: no nausea or vomiting, 2: queasy, 3: severe nausea, 4: vomiting	4 hours postoperative
Secondary	postoperative nausea and vomiting	four-point rating score (1: no nausea or vomiting, 2: queasy, 3: severe nausea, 4: vomiting	24 hours postoperative
Secondary	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
Secondary	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
Secondary	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