Elective Total Abdominal Hysterectomy With Preoperative Analgesia Intravenous Paracetamol Versus Placebo

A Comparison of Postoperative Morphine Consumption in Patients Undergoing 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

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Paracetamol; Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Chon Buri, Thailand
    • Queen Savang Vadhana Memorial Hospital, Thai Red Cross Society, Jermjomphon street, Chonburi, 20110,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria

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

Exclusion criteria

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Paracetamol; Patients which recieved intravenous paracetamol preoperatively	Drug: Paracetamol; 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 Comparator: Placebo; Patients which recieved placebo preoperatively	Drug: Placebo; Pateint recieved IV normal saline Postoperatively, pain was assessed intermittently using the NRS (์numeric rating scale) at 1, 6, 12, and 24 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Compare postoperative morphine consumption between the IV paracetamol and control groups.	at 1, 6, 12, and 24 hours postoperation

Secondary Outcome Measures

Outcome Measure	Time Frame
Compare postoperative pain scores using the Numeric Rating Scale OR NRS	at 1, 6, 12, and 24 hours postoperation

Collaborators and Investigators

• Sponsor: Queen Savang Vadhana Memorial Hospital, Thailand
• Investigators: Principal Investigator: Panumat Phungtippimanchai, Queen Savang Vadhana Memorial Hospital, Thailand

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2024
• Primary Completion (Actual): May 20, 2025
• Study Completion (Actual): August 20, 2025

Study Registration Dates

• First Submitted: January 20, 2026
• First Submitted That Met QC Criteria: January 20, 2026
• First Posted (Actual): January 27, 2026

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Paracetamol, Morphine, Total abdominal hysterectomy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Acetaminophen
• Other Study ID Numbers: 011/2567

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: data was save in form of microsoft excel spreadsheet and SPSS file

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No