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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07368790

Enrollment

Registered

2026-01-27

Start date

2024-10-10

Completion date

2025-08-20

Last updated

2026-01-27

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

Conditions

Postoperative Pain

Keywords

Paracetamol, Morphine, Total abdominal hysterectomy

Brief summary

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

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.

Interventions

DRUGParacetamol

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.

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 50 Years

Healthy volunteers

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).

Design outcomes

Primary

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

Secondary

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

Countries

Thailand

Contacts

PRINCIPAL_INVESTIGATORPanumat Phungtippimanchai

Queen Savang Vadhana Memorial Hospital, Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026