Adding Nalbuphine for Control of Intrathecal Morphine Pruritus

Minia University

Status and phase: Unknown; Phase 2

Conditions: Vomiting, Postoperative; Pain, Postoperative; Nausea, Postoperative; Pruritus

Treatments: Drug: Nalbuphine Hydrochloride 10 MG/ML; Drug: Morphine 10 MG/ML

Study type: Interventional

Funder types: Other

Identifiers

NCT04589429

678-9/2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups, including a placebo group

MN group

Active Comparator group

Description:

intrathecal morphine 300 micrograms+2mg nalbuphine

Treatment:

Drug: Morphine 10 MG/ML

Drug: Nalbuphine Hydrochloride 10 MG/ML

M group

Placebo Comparator group

Description:

intrathecal morphine 300 micrograms

Treatment:

Drug: Morphine 10 MG/ML