Adding Nalbuphine for Control of Intrathecal Morphine Pruritus

• Sponsor: Minia University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04589429
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 4.5
• Patients Per Site Per Month: 15.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pruritus; Pain, Postoperative; Nausea, Postoperative; Vomiting, Postoperative	Drug: Morphine 10 MG/ML; Drug: Nalbuphine Hydrochloride 10 MG/ML	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Does Adding Nalbuphine to Intrathecal Morphine Reduce Morphine Induced Pruritus? A Randomized, Double Blind, Controlled Study.
• Actual Study Start Date: Oct 15, 2020
• Anticipated Primary Completion Date: Mar 1, 2021
• Anticipated Study Completion Date: Mar 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. pruritus [2 hours postoperatively]

   Pruritus score (1: no pruritus; 2: mild pruritus, treatment not requested; 3: moderate pruritus, treatment requested; 4: severe pruritus).

2. pruritus [4 hours postoperatively]

   Pruritus score (1: no pruritus; 2: mild pruritus, treatment not requested; 3: moderate pruritus, treatment requested; 4: severe pruritus).

3. 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

1. postoperative pain [2 hours postoperative]

   assessed with a verbal numeric pain score(NRS) where 0: no pain; 10: worst imaginable pain

2. postoperative pain [4 hours postoperative]

   assessed with a verbal numeric pain score(NRS) where 0: no pain; 10: worst imaginable pain

3. postoperative pain [24 hours postoperative]

   assessed with a verbal numeric pain score(NRS) where 0: no pain; 10: worst imaginable pain

4. postoperative nausea and vomiting [2 hours postoperative]

   four-point rating score (1: no nausea or vomiting, 2: queasy, 3: severe nausea, 4: vomiting

5. postoperative nausea and vomiting [4 hours postoperative]

   four-point rating score (1: no nausea or vomiting, 2: queasy, 3: severe nausea, 4: vomiting

6. postoperative nausea and vomiting [24 hours postoperative]

   four-point rating score (1: no nausea or vomiting, 2: queasy, 3: severe nausea, 4: vomiting

7. Sedation [2 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).

8. Sedation [4 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).

9. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	anesthesia&ICU department	Minya		Egypt

Sponsors and Collaborators

• Minia University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sohair Adeeb, Principle investigator, Minia University
• ClinicalTrials.gov Identifier: NCT04589429
• Other Study ID Numbers: 678-9/2020
• First Posted: Oct 19, 2020
• Last Update Posted: Mar 1, 2021
• Last Verified: Feb 1, 2021

• 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
• Keywords provided by Sohair Adeeb, Principle investigator, Minia University: pruritus; intrathecal morphine; intrathecal nalbuphine
• Additional relevant MeSH terms: Pruritus; Vomiting; Pain, Postoperative; Postoperative Nausea and Vomiting; Morphine; Nalbuphine

Study Results

No Results Posted as of Mar 1, 2021