Elective Total Abdominal Hysterectomy With Preoperative Analgesia Intravenous Paracetamol Versus Placebo

NCT07368790 | Completed DMC

• 1 other identifier: 011/2567
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Pain

Keywords

Paracetamol, Morphine, Total abdominal hysterectomy

Outcome Measures

Primary Outcomes (1)

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

  at 1, 6, 12, and 24 hours postoperation

Secondary Outcomes (1)

• Compare postoperative pain scores using the Numeric Rating Scale OR NRS

  at 1, 6, 12, and 24 hours postoperation

Study Arms (2)

Paracetamol

EXPERIMENTAL

Patients which recieved intravenous paracetamol preoperatively

Drug: Paracetamol

Placebo

PLACEBO COMPARATOR

Patients which recieved placebo preoperatively

Drug: Placebo

Interventions

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.

Paracetamol

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

Placebo

Eligibility Criteria

• Age: 30 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Queen Savang Vadhana Memorial Hospital, Thailand: lead

Study Sites (1)

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

Chon Buri, Thailand

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Panumat Phungtippimanchai

  Queen Savang Vadhana Memorial Hospital, Thailand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: January 27, 2026
• Study Start: October 10, 2024
• Primary Completion: May 20, 2025
• Study Completion: August 20, 2025
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

TH (1)