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OpenTrials
Completed

NCT Number: NCT07401927

Preemptive Analgesia in Laparoscopic Hysterectomy

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.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Operating Room at the Giresun Obstetrics and Gynecology and Pediatrics Training and Research Hospital

Giresun, Turkey (Türkiye)

About this study

Patients who undergo laparoscopic hysterectomy surgery are administered certain treatment methods for postoperative analgesia. These applications are a routine part of the procedure. They are medically and ethically necessary. Postoperative analgesia applications are initiated during the intraoperative process and continued during the postoperative process. The analgesia protocol to be used is determined by the patient's characteristics and the anaesthetist's experience. Multimodal analgesia protocols are scientifically accepted methods. Preemptive analgesia, a method used for pain control that reduces the severity of pain caused by analgesics, delays the initial need for analgesia, and reduces the need for painkillers, is one of these protocols. This method, applied before surgical incision or tissue damage, covers a wide range, from first-line analgesics such as paracetamol and ibuprofen to opioids and peripheral and central blocks. The aim of this study is to evaluate the effects of ibuprofen and paracetamol administered for preemptive analgesia in patients undergoing laparoscopic hysterectomy on pain scores in the first 24 hours postoperatively, the amount of opioids consumed postoperatively, and adverse effects such as postoperative nausea and vomiting.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Ibuprofen

Drug

Administered as part of standard institutional anesthesia practice.

Other names: ibuprofen 400 mg

Parasetamol

Drug

Administered as part of standard institutional anesthesia practice.

Other names: parasetamol 1 g

Primary outcomes

  1. Postoperative analgesia

    Time frame: from the end of surgery up to 24 hours postopeartively

    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.

Secondary outcomes

  1. İntraoperative analgesia

    Time frame: During surgery (from skin incision until the end of surgery)

    Intraoperative analgesia was assessed by evaluating hemodynamic responses to surgical stimuli, including changes in heart rate and mean arterial pressure, as well as the requirement for additional intraoperative analgesic agents.

    Stable hemodynamic parameters and a reduced need for supplemental analgesia were considered indicators of adequate intraoperative analgesia.stimuli, including changes in heart rate and mean arterial pressure, as well as the requirement for additional intraoperative analgesic agents. Stable hemodynamic parameters and reduced need for supplemental analgesia were considered indicators of adequate intraoperative analgesia.

  2. Intraoperative hemodynamic instability

    Time frame: During surgery (from induction of anesthesia until the end of surgery)

    Intraoperative hemodynamic instability was assessed by continuous monitoring of heart rate and mean arterial pressure throughout the surgical procedure.

    Hemodynamic instability was defined as the occurrence of hypotension, hypertension, bradycardia, or tachycardia based on deviations from baseline values.

Sponsors and collaborators

Lead sponsor

Giresun University

Other

Registry information

Official study title

The Effects of Preemptive Analgesic Protocols on Perioperative Pain Management in Laparoscopic Hysterectomy: A Prospective Observational Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 11, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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