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

T

Thammasat University

Status

Completed

Conditions

Neuraxial Opioid
Caesarean Section
Postoperative Nausea and Vomiting
Intrathecal Morphine

Treatments

Drug: A single dose of 4 mg iv nalbuphine

Study type

Interventional

Funder types

Other

Identifiers

NCT06837129
MTU-EC-AN-1-130/66

Details and patient eligibility

About

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

Full description

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.

Enrollment

180 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

180 participants in 2 patient groups

IV NALBUPHINE
Experimental group
Description:
A single dose of 4 MG IV nalbuphine is given after cord clamping in study group
Treatment:
Drug: A single dose of 4 mg iv nalbuphine
conventional
No Intervention group
Description:
no medications is given

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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