NCT06594224

Brief Summary

The local data is insufficient to directly compare IV nalbuphine versus ibuprofen among people in this region. The findings of this study would add to the existing data and would be helpful for health providers to opt for a better option for postoperative pain relief following a cesarean section under general anesthesia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

6 months

First QC Date

September 9, 2024

Last Update Submit

September 10, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Efficacy in pain control

    Outcome was noted in the form of VAS pain scores. Scores from 1 to 3 were labeled as mild pain, 4 to 6 as moderate pain, and 7 to 10 as severe pain.

    At 1 hour, 3 hours, and 6 hours.

Study Arms (2)

IV Ibuprofen Group

EXPERIMENTAL

Females in this group (n=40) were given 800 mg Ibuprofen in 200 cc normal saline intravenously at the time of arrival in the ward

Drug: Ibuprofen

IV Nalbuphine

EXPERIMENTAL

Patients in this group received 20 mg nalbuphine in 200 cc normal saline IV at the time of arrival in the ward.

Drug: Nalbuphine

Interventions

Patients were given 800 mg Ibuprofen in 200 cc normal saline intravenously at the time of arrival in the ward.

IV Ibuprofen Group

Patients received 20 mg nalbuphine in 200 cc normal saline IV at the time of arrival in the ward.

IV Nalbuphine

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Parturient females
  • Aged between 18-45 years
  • Gestational age above 32 weeks
  • ASA class I to II
  • Anticipated hospital stay for at least 24 hours

You may not qualify if:

  • Known allergy to the drugs being evaluated in this study
  • Renal and/or hepatic impairment (as per medical record)
  • History of bronchial asthma or history or risk of intracranial hemorrhage (as per medical record)
  • Low platelets count (\<70000) or with bleeding diathesis
  • BMI above 30 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nishtar Hospital

Multan, Punjab Province, 66000, Pakistan

Location

Nishtar Medical University

Multan, Punjab Province, 66000, Pakistan

Location

Related Publications (1)

  • Khakwani M, Parveen R, Sultana H. Comparison of IV Nalbuphine versus ibuprofen for Postoperative Pain control in cesarean section. Pak J Med Sci. 2025 Sep;41(9):2612-2617. doi: 10.12669/pjms.41.9.11016.

MeSH Terms

Conditions

Agnosia

Interventions

IbuprofenNalbuphine

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Mehnaz Khakwani, FCPS

    Department of Obstetric and Gynecology Nishtar Medical University, Multan

    PRINCIPAL INVESTIGATOR
  • Hajra Sultana, FCPS

    Department of Obstetric and Gynecology Nishtar Medical University, Multan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
RESnTEC, Institute of Research

Study Record Dates

First Submitted

September 9, 2024

First Posted

September 19, 2024

Study Start

March 1, 2024

Primary Completion

August 31, 2024

Study Completion

August 31, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Data can be shared with other researchers on a reasonable request

Locations