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Adding Nalbuphine for Control of Intrathecal Morphine Pruritus

Primary Purpose

Pruritus, Pain, Postoperative, Nausea, Postoperative

Status

Unknown status

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Morphine 10 MG/ML

Nalbuphine Hydrochloride 10 MG/ML

About this trial

This is an interventional prevention trial for Pruritus focused on measuring pruritus, intrathecal morphine, intrathecal nalbuphine

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

anesthesia&ICU departmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

MN group

M group

Arm Description

intrathecal morphine 300 micrograms+2mg nalbuphine

intrathecal morphine 300 micrograms

Outcomes

Primary Outcome Measures

pruritus

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

pruritus

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

pruritus

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

Secondary Outcome Measures

postoperative pain

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

postoperative pain

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

postoperative pain

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

postoperative nausea and vomiting

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

postoperative nausea and vomiting

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

postoperative nausea and vomiting

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

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).

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).

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).

Full Information

NCT ID

NCT04589429

First Posted

September 27, 2020

Last Updated

February 26, 2021

Sponsor

Minia University

1. Study Identification

Unique Protocol Identification Number

NCT04589429

Brief Title

Adding Nalbuphine for Control of Intrathecal Morphine Pruritus

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Unknown status

Study Start Date

October 15, 2020 (Actual)

Primary Completion Date

March 2021 (Anticipated)

Study Completion Date

March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Minia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pruritus, Pain, Postoperative, Nausea, Postoperative, Vomiting, Postoperative

Keywords

pruritus, intrathecal morphine, intrathecal nalbuphine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MN group

Arm Type

Active Comparator

Arm Description

intrathecal morphine 300 micrograms+2mg nalbuphine

Arm Title

M group

Arm Type

Placebo Comparator

Arm Description

intrathecal morphine 300 micrograms

Intervention Type

Drug

Intervention Name(s)

Morphine 10 MG/ML

Other Intervention Name(s)

morphine

Intervention Description

intrathecal morphine 300 micrograms

Intervention Type

Drug

Intervention Name(s)

Nalbuphine Hydrochloride 10 MG/ML

Other Intervention Name(s)

nalbuphine

Intervention Description

intrathecal nalbuphine 2mg.

Primary Outcome Measure Information:

Title

pruritus

Description

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

Time Frame

2 hours postoperatively

Title

pruritus

Description

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

Time Frame

4 hours postoperatively

Title

pruritus

Description

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

Time Frame

24 hours postoperatively

Secondary Outcome Measure Information:

Title

postoperative pain

Description

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

Time Frame

2 hours postoperative

Title

postoperative pain

Description

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

Time Frame

4 hours postoperative

Title

postoperative pain

Description

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

Time Frame

24 hours postoperative

Title

postoperative nausea and vomiting

Description

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

Time Frame

2 hours postoperative

Title

postoperative nausea and vomiting

Description

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

Time Frame

4 hours postoperative

Title

postoperative nausea and vomiting

Description

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

Time Frame

24 hours postoperative

Title

Sedation

Description

four-point sedation score (1: fully awake; 2: somnolent, responds to call; 3: somnolent, responds to tactile stimulation; 4: asleep, responds to painful stimulation).

Time Frame

2 hours postoperative

Title

Sedation

Description

four-point sedation score (1: fully awake; 2: somnolent, responds to call; 3: somnolent, responds to tactile stimulation; 4: asleep, responds to painful stimulation).

Time Frame

4 hours postoperative

Title

Sedation

Description

four-point sedation score (1: fully awake; 2: somnolent, responds to call; 3: somnolent, responds to tactile stimulation; 4: asleep, responds to painful stimulation).

Time Frame

24 hours postoperative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sohair A Megalla, MD

Phone

+20 120 003 6447

Sohair.Adeeb@minia.edu.eg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sohair A Megalla, MD

Organizational Affiliation

Anesthesia and ICU department, Faculty of Medicine, Minia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

anesthesia&ICU department

City

Minya

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

sohair A Megalla, MD

Phone

01200036447

Sohair.Adeeb@minia.edu.eg

12. IPD Sharing Statement

Learn more about this trial

Adding Nalbuphine for Control of Intrathecal Morphine Pruritus

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