Elective Total Abdominal Hysterectomy With Preoperative Analgesia Intravenous Paracetamol Versus Placebo

Queen Savang Vadhana Memorial Hospital, Thailand

Status: Completed

Conditions: Postoperative Pain

Treatments: Drug: Paracetamol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07368790

011/2567

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 30 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Paracetamol

Experimental group

Description:

Patients which recieved intravenous paracetamol preoperatively

Treatment:

Drug: Paracetamol

Placebo

Placebo Comparator group

Description:

Patients which recieved placebo preoperatively

Treatment:

Drug: Placebo