Postoperative AnalgesiaNCT07401927
Preemptive Analgesia in Laparoscopic Hysterectomy
An observational study of Postoperative Analgesia and Laparoscopic Hysterectomy, run by Giresun University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Postoperative Analgesia, Laparoscopic Hysterectomy
- What is being tested?
- Ibuprofen and Parasetamol
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Feb 2026to 1 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients aged 18 to 70 who are scheduled to undergo laparoscopic hysterectomy surgery.
Who may be able to join
- Aged 18-70
- ASA I-III patients
- Patients undergoing elective laparoscopic hysterectomy surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Operating Room at the Giresun Obstetrics and Gynecology and Pediatrics Training and Research Hospital
Giresun
About this study
Official title: The Effects of Preemptive Analgesic Protocols on Perioperative Pain Management in Laparoscopic Hysterectomy: A Prospective Observational Study
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.
Read the detailed description
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.
- Conditions
- Postoperative Analgesia, Laparoscopic Hysterectomy
- Being tested
- Ibuprofen, Parasetamol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Also called ibuprofen 400 mg
Administered as part of standard institutional anesthesia practice.
ParasetamolDrug
Also called parasetamol 1 g
Administered as part of standard institutional anesthesia practice.
| Study group | Role | What they receive |
|---|---|---|
| Group İ (İbuprofen) | Patients who are administered ibuprofen pre-emptively analgesia, in accordance with routine clinical practice. Receives: Drug: Ibuprofen | |
| Group P (Parasetamol) | Patients who are administered parasetamol pre-emptively analgesia, in accordance with routine clinical practice. Receives: Drug: Parasetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from the end of surgery up to 24 hours postopeartively
Secondary outcomes (2)
İntraoperative analgesia
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.
Measured: During surgery (from skin incision until the end of surgery)
Intraoperative hemodynamic instability
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.
Measured: During surgery (from induction of anesthesia until the end of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start2 Feb 2026
- Primary completion1 Apr 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Giresun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Yeniay, Giresun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401927
- Sponsor's protocol ID
- GOKAEK 2025/13/9
- Status last verified
- May 2026
- First submitted
- 27 Jan 2026
- Last updated
- 18 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical and confidentiality considerations
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Preemptive Analgesic Protocols on Perioperative Pain Management in Laparoscopic Hysterectomy: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07401927
- Acronym / sponsor ID
- GOKAEK 2025/13/9
- Conditions
- Postoperative Analgesia, Laparoscopic Hysterectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Giresun UniversityUniversity, hospital or other
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group İ (İbuprofen) | – | Drug: IbuprofenPatients who are administered ibuprofen pre-emptively analgesia, in accordance with routine clinical practice. |
| Group P (Parasetamol) | – | Drug: ParasetamolPatients who are administered parasetamol pre-emptively analgesia, in accordance with routine clinical practice. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients aged 18 to 70 who are scheduled to undergo laparoscopic hysterectomy surgery.
Key inclusion criteria (3 listed)
- Aged 18-70
- ASA I-III patients
- Patients undergoing elective laparoscopic hysterectomy surgery
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IbuprofenAlso: ibuprofen 400 mgAdministered as part of standard institutional anesthesia practice. | Drug | Group İ (İbuprofen) |
| ParasetamolAlso: parasetamol 1 gAdministered as part of standard institutional anesthesia practice. | Drug | Group P (Parasetamol) |
Primary outcome
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.
2 secondary outcomes
İntraoperative analgesia
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical and confidentiality considerations
Related trials for Postoperative Analgesia
RecruitingPhase 4
Anrikefon-based Patient-controlled Intravenous Analgesia Following Laparoscopic Surgery
Laparoscopic Surgery, Visceral Pain, Postoperative
Recruiting
NOL Guided Analgesia During Elective Laparoscopic Surgery Under General Anesthesia
Intraoperative Analgesia
Recruiting
Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery
Postoperative Pain, Facial Swelling
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Recruiting
Lateral QL Block vs Intrathecal Morphine for Cesarean Section
Anesthesia, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Analgesia and Laparoscopic Hysterectomy, run by Giresun University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative analgesia (time frame: from the end of surgery up to 24 hours postopeartively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.