- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07401927
Preemptive Analgesia in Laparoscopic Hysterectomy
The Effects of Preemptive Analgesic Protocols on Perioperative Pain Management in Laparoscopic Hysterectomy: A Prospective Observational Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Giresun, Turkey (Türkiye)
- Operating Room at the Giresun Obstetrics and Gynecology and Pediatrics Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group İ (İbuprofen)
Patients who are administered ibuprofen pre-emptively analgesia, in accordance with routine clinical practice.
|
Administered as part of standard institutional anesthesia practice.
Other Names:
|
|
Group P (Parasetamol)
Patients who are administered parasetamol pre-emptively analgesia, in accordance with routine clinical practice.
|
Administered as part of standard institutional anesthesia practice.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
from the end of surgery up to 24 hours postopeartively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
During surgery (from skin incision until the end of surgery)
|
|
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. |
During surgery (from induction of anesthesia until the end of surgery)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GOKAEK 2025/13/9
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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