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Nefopam-Pentazocine Superiority Trial

A Randomised Controlled Trial Comparing the Post Operative Analgesic Efficacy of Nefopam with Pentazocine after Major Gynaecology Surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202504896555199
Enrollment
110
Registered
2025-04-30
Start date
2025-07-01
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Surgery Post Operative Pain Management after Gynaecology Surgery Post Operative Pain Management after Gynaecology Surgery

Interventions

Sponsors

Bankole ADEWUMI
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: This will include women scheduled for major gynaecology surgery who are • 19yrs of age to 64 years of age • to undergo a major gynaecology procedure under spinal anaesthesia with or without epidural anaesthesia and with estimated duration of surgery not more than 3 hours. • Patients with normal renal and liver function test

Exclusion criteria

Exclusion criteria: This will include participants scheduled for major gynaecology surgery who are • 18years old and below and above 64year of age. • Having the surgery under general anaesthesia. • With history of prolonged use of opioid analgesics e.g. sickle cell patients, patients with neuropathy etc • Diagnosed or being managed for cancers or malignancies • With history of adverse reactions to local anaesthetics, pentazocine, nefopam and diclofenac • With deranged liver or kidney function test or coagulopathy • Visually impaired

Design outcomes

Primary

MeasureTime frame
The primary outcome measure will be the pain scores of the participant on Nefopam or Pentazocine in a multimodal analgesia after major gynaecology surgery

Secondary

MeasureTime frame
The adverse effects observed for either of the study drugs group e.g. nausea, vomiting, shivering, tachycardia, hypotension, respiratory depression, sweating etc. associated with the medication;The effects of either of the study drugs on the patients’ hemodynamics which include the Respiratory Rate, Heart Rate, Systolic and Disastolic Blood Pressure and Oxygen Saturation in room air.;The total dose of rescue analgesia consumed for those that have pain score more than 5 before being due for the next dose of study analgesics;The overall level of satisfaction with the management of post operative pain after the surgery

Countries

Nigeria

Contacts

Public ContactBankole ADEWUMI

Resident Doctor and Principal Investigator

bankole.adewumi@uch-ibadan.org.ng+2348033967253

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026