Adding Nalbuphine for Control of Intrathecal Morphine Pruritus

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04589429

Enrollment

Registered

2020-10-19

Start date

2020-10-15

Completion date

2021-03-31

Last updated

2021-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

pruritus, intrathecal morphine, intrathecal nalbuphine

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.

Interventions

DRUGMorphine 10 MG/ML

intrathecal morphine 300 micrograms

DRUGNalbuphine Hydrochloride 10 MG/ML

intrathecal nalbuphine 2mg.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
postoperative pain	2 hours postoperative	assessed with a verbal numeric pain score(NRS) where 0: no pain; 10: worst imaginable pain
postoperative nausea and vomiting	2 hours postoperative	four-point rating score (1: no nausea or vomiting, 2: queasy, 3: severe nausea, 4: vomiting
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).

Countries

Egypt

Contacts

Primary ContactSohair A Megalla, MD

Sohair.Adeeb@minia.edu.eg+20 120 003 6447

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026