Acetaminophen vs Placebo for Postoperative Analgesia After Abdominal Surgery | NCT07720791

NCT07720791

Overview

NCT ID: NCT07720791
Lead Sponsor: Konya City HospitalOTHER
Official Title: Comparison of Placebo and Acetaminophen on Postoperative Opioid Consumption in Non-Cardiac Abdominal Surgery
Brief Summary: This study investigates whether oral acetaminophen, when added to standard pain management, reduces opioid use and pain after major abdominal surgery, compared to a placebo (inactive pill). Patients undergoing planned abdominal surgery under general anesthesia will be randomly assigned to receive either acetaminophen or a placebo tablet before surgery and every 6 hours afterward for 48 hours, in addition to their usual pain medication. Researchers will measure how much opioid pain medication patients need, how much pain they report, and how satisfied they are with their pain control during the first two days after surgery. The goal is to determine whether oral acetaminophen provides a genuine benefit beyond placebo in reducing opioid use while maintaining adequate pain control.
Conditions: Pain, Postoperative

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 22, 2026Actual
Start Date: Jul 15, 2026Estimated
Primary Completion Date: Jul 15, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Written informed consent

Age ≥ 18 years

ASA physical status I, II, or III

Scheduled for elective non-cardiac abdominal surgery with expected surgery duration ≥ 2 h-hours

General anesthesia

Planned hospital stay of at least 48 hours

Exclusion Criteria:

Pregnant or nursing (breastfeeding) women

Neurologic deficit or chronic pain disease

Planned use of regional anesthesia techniques for postoperative pain

Emergency surgery

Study Plan

Study Type: Interventional
Phase: Phase 4
Enrollment: 1,504Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Triple

Contacts and Locations

Central Contacts: Yasin TireContact
dryasintire@hotmail.com+905055367970

Similar Studies

Masking Description

This is a triple-blind study. Participants, care providers, and outcomes assessors are all blinded to treatment allocation. Acetaminophen and placebo tablets are identical in appearance, packaging, and administration schedule, making them indistinguishable to anyone involved in clinical care or outcome assessment. Treatment allocation is generated and maintained by the randomization system (REDCap) and is known only to personnel responsible for randomization and drug dispensing, who have no role in patient care, pain assessment, or outcome evaluation. The blinded outcomes assessor independently records pain scores and opioid consumption data, with no knowledge of group assignment.

Participant Group/Arms

AcetaminophenActive Comparator

Arm 1: Acetaminophen (Arm Type: Experimental) Participants will receive oral acetaminophen 1000 mg, administered 30 minutes before surgery and every 6 hours postoperatively for 48 hours.

Drug: Acetaminophen

PlaceboPlacebo Comparator

Participants will receive a matching placebo tablet, administered 30 minutes before surgery and every 6 hours postoperatively for 48 hours.

Drug: Acetaminophen