Intravenous Nalbuphine for Prevention of Intrathecal Morphine-induced Nausea and Vomiting in Patients Undergoing Cesarean Section: A Double-blind, Randomized Controlled Trial.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-15

Study Completion Date

2025-02-20

Brief Summary

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We study efficacy of iv nalbuphine in prevention of intrathecal morphine-induced nausea and vomiting in patients undergoing cesarean section.

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Detailed Description

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IV nalbuphine has been proved to help prevent intrathecal morphine-induced pruritus in some studies but results in nausea vomiting prevention have not been well studied. In Thailand, most caesarean section is done under spinal anesthesia with intrathecal morphine, proving that iv nalbuphine is effective would be beneficial for our population. This study aims to see whether 4 mg of nalbuphine is effective in reducing incidence of intrathecal morphine-related nausea vomiting in parturient who underwent C-section under spinal anesthesia with 0.2 mg of intrathecal morphine.

Conditions

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Intrathecal Morphine Caesarean Section Postoperative Nausea and Vomiting Neuraxial Opioid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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IV NALBUPHINE

A single dose of 4 MG IV nalbuphine is given after cord clamping in study group

Group Type EXPERIMENTAL

A single dose of 4 mg iv nalbuphine

Intervention Type DRUG

prevention of nausea vomiting

conventional

no medications is given

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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A single dose of 4 mg iv nalbuphine

prevention of nausea vomiting

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Elective cesarean section under spinal anesthesia
* age \> 18 years

Exclusion Criteria

* Patients with known allergy to medications used in this study (nalbuphine, bupivacaine or morphine)
* Patient with medical conditions which spinal anesthesia is contraindicated ie. heart diseases, renal or hepatic impairment, obesity \>=100 kilograms
* Patients with history of postoperative nausea and vomiting (PONV) or motion sickness who may have preexisting risk factors for PONV
* Patient with known history of drug abuse
* Unwilling to participate in the study

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes