NCT07401927

Brief Summary

The aim of this study is to evaluate the effects of ibuprofen and paracetamol administered for pre-emptive analgesia to patients undergoing laparoscopic hysterectomy on pain scores during the first 24 hours postoperatively, the amount of opioids consumed postoperatively, and adverse effects such as postoperative nausea and vomiting.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

February 2, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

January 27, 2026

Last Update Submit

February 3, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative analgesia

    Postoperative analgesia was assessed by measuring postoperative pain intensity using the Visual Analog Scale (VAS) and by recording cumulative opioid or rescue analgesic consumption. The Visual Analog Scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Lower pain scores and reduced analgesic requirements were considered indicators of better postoperative analgesia.

    from the end of surgery up to 24 hours postopeartively

Secondary Outcomes (2)

  • İntraoperative analgesia

    During surgery (from skin incision until the end of surgery)

  • Intraoperative hemodynamic instability

    During surgery (from induction of anesthesia until the end of surgery)

Study Arms (2)

Group İ (İbuprofen)

Patients who are administered ibuprofen pre-emptively analgesia, in accordance with routine clinical practice.

Drug: Ibuprofen

Group P (Parasetamol)

Patients who are administered parasetamol pre-emptively analgesia, in accordance with routine clinical practice.

Drug: Parasetamol

Interventions

Administered as part of standard institutional anesthesia practice.

Also known as: ibuprofen 400 mg
Group İ (İbuprofen)

Administered as part of standard institutional anesthesia practice.

Also known as: parasetamol 1 g
Group P (Parasetamol)

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Female patients aged 18 to 70 who are scheduled to undergo laparoscopic hysterectomy surgery.

You may qualify if:

  • Aged 18-70
  • ASA I-III patients
  • Patients undergoing elective laparoscopic hysterectomy surgery

You may not qualify if:

  • Emergency surgery
  • Patients who require conversion to abdominal hysterectomy during the intraoperative period
  • Those with severe liver or kidney failure, a history of long-term nonsteroidal anti-inflammatory and opioid analgesic use
  • Those with a history of gastrointestinal bleeding, peptic ulcer or inflammatory bowel disease, diabetes or other neuropathic diseases
  • Patients unable to use patient-controlled analgesia (PCA) devices

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Ibuprofen

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiology and Reanimation physician

Study Record Dates

First Submitted

January 27, 2026

First Posted

February 11, 2026

Study Start

February 2, 2026

Primary Completion

April 1, 2026

Study Completion

May 1, 2026

Last Updated

February 11, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to ethical and confidentiality considerations