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Completed

NCT Number: NCT07368790

Elective Total Abdominal Hysterectomy With Preoperative Analgesia Intravenous Paracetamol Versus Placebo

The study aim to study to evaluate whether IV paracetamol reduces morphine use after TAH. Primary objective was to compare postoperative morphine consumption between the IV paracetamol and control groups.

and Secondary objective was to compare postoperative pain scores using the Numeric Rating Scale OR NRS

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Key information

Age range

30 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Queen Savang Vadhana Memorial Hospital, Thai Red Cross Society, Jermjomphon street, Chonburi, 20110,

Chon Buri, Thailand

About this study

We conducted a randomized, double-blind, placebo-controlled trial at our hospital (QSMH) , including women undergoing elective TAH The trial was conducted between October 2024 (two thousand twenty-four) and May 2025 (two thousand twenty-five) , with approval from the institutional review board.

Participants were randomized 1:1 (one to one) to receive IV paracetamol 1 g or IV normal saline, administered in the operating room before induction of anesthesia, Postoperatively, pain was assessed intermittently using the NRS (์numeric rating scale) at 1, 6, 12, and 24 hours, with morphine 0.1 mg/kg (zero point one milligrams per kilogram) Intravenous provided on demand.

The primary outcome was the number of morphine injections within 24 hours; the secondary outcome was NRS pain scores.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female patients aged 30-50 years.
  • Scheduled to undergo total abdominal hysterectomy (TAH) at Queen Savang Vadhana Memorial Hospital at Sriracha
  • No history of allergy to paracetamol (acetaminophen) or morphine.
  • Normal renal function: serum creatinine ≤ 1.2 mg/dL.
  • No severe or recurrent liver disease, and AST or ALT ≤ 3× the upper limit of normal.
  • Able to communicate in Thai, complete the questionnaire, and provide written informed consent (no restriction on race or nationality).

Exclusion criteria

  • Incomplete medical record.
  • Use of any analgesic medications within 24 hours preoperatively.
  • Receipt of any postoperative analgesic other than morphine during the first 24 hours after surgery.
  • Withdrawal from the study.
  • Adverse reaction after administration of the study drug.
  • Concomitant surgery involving other organs (e.g., ovary or lymph nodes).

Treatment and study plan

Paracetamol

Drug

Patients receive IV paracetamol 1 gm Postoperatively morphine 0.1 mg/kg was given intravenous provided on demand at at 1, 6, 12, and 24 hours.

Placebo

Drug

Pateint recieved IV normal saline Postoperatively, pain was assessed intermittently using the NRS (์numeric rating scale) at 1, 6, 12, and 24 hours

Primary outcomes

  1. Compare postoperative morphine consumption between the IV paracetamol and control groups.

    Time frame: at 1, 6, 12, and 24 hours postoperation

Secondary outcomes

  1. Compare postoperative pain scores using the Numeric Rating Scale OR NRS

    Time frame: at 1, 6, 12, and 24 hours postoperation

Sponsors and collaborators

Lead sponsor

Queen Savang Vadhana Memorial Hospital, Thailand

Other

Registry information

Official study title

A Comparison of Postoperative Morphine Consumption in Patients Undergoing Elective Total Abdominal Hysterectomy With Preoperative Analgesia Intravenous Paracetamol Versus Placebo

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 27, 2026
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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