An interventional study of Ultrasound-Guided Bilateral Quadro-Iliac Plane Block and Ultrasound-Guided Bilateral Transversus Abdominis Plane Block in Postoperative Pain Following Total Laparoscopic Hysterectomy, sponsored by Hitit University. Not yet recruiting. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Hitit University · Not applicable, Interventional, and Supportive care
Postoperative pain management is an important component of recovery after total laparoscopic hysterectomy. Regional anesthesia techniques may reduce postoperative opioid consumption and improve patient comfort.
This prospective, randomized, double-blind clinical trial aims to compare the postoperative analgesic efficacy of ultrasound-guided bilateral Quadro-Iliac Plane Block (QIPB) and bilateral Transversus Abdominis Plane Block (TAPB) in patients undergoing total laparoscopic hysterectomy.
A total of 60 patients will be randomly assigned to two groups, with 30 patients in each group. One group will receive bilateral QIPB, while the other group will receive bilateral TAPB before surgery.
The primary outcome will be total opioid consumption during the first 24 postoperative hours. Secondary outcomes will include postoperative pain scores, sensory block assessment, postoperative nausea and vomiting, quality of recovery, and time to first mobilization.
The study aims to determine the comparative analgesic effectiveness of these two regional anesthesia techniques and contribute to optimizing postoperative pain management after total laparoscopic hysterectomy.
This study is designed as a prospective, randomized, double-blind clinical trial at Hitit University Erol Olçok Training and Research Hospital, Türkiye.
The study will include 60 adult patients scheduled for total laparoscopic hysterectomy under general anesthesia. Eligible patients will have American Society of Anesthesiologists (ASA) physical status I-III and will provide written informed consent before enrollment.
Participants will be randomly allocated into two groups using computer-generated randomization and sealed envelopes:
Group T (n=30): Patients will receive ultrasound-guided bilateral Transversus Abdominis Plane Block (TAPB).
Group Q (n=30): Patients will receive ultrasound-guided bilateral Quadro-Iliac Plane Block (QIPB).
Both regional anesthesia techniques will be performed preoperatively by an experienced anesthesiologist under ultrasound guidance. Patients, the surgical team, and postoperative outcome assessors will be blinded to group allocation. The anesthesiologist performing the blocks will not participate in postoperative assessments.
All patients will receive standardized general anesthesia and multimodal postoperative analgesia, including intravenous paracetamol and patient-controlled analgesia (PCA) with tramadol. Rescue analgesia will be provided according to the study protocol.
The primary outcome will be cumulative opioid consumption during the first 24 postoperative hours.
Postoperative pain intensity will be evaluated using the Numerical Rating Scale (NRS) at rest and during movement at 0, 1, 3, 6, 12, 18, and 24 hours after surgery.
Sensory block effectiveness will be evaluated using bilateral pinprick testing at postoperative hours 2 and 24.
Quality of recovery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15) preoperatively and at postoperative hour 24.
Additional postoperative assessments will include nausea and vomiting, rescue analgesic requirements, time to first opioid requirement, hemodynamic parameters, time to first mobilization, time to first oral intake, and return of bowel function.
The results will be used to compare the analgesic effectiveness and postoperative recovery outcomes associated with bilateral QIPB and bilateral TAPB in patients undergoing total laparoscopic hysterectomy.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 60 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Hitit University is the lead sponsor of 87 studies on the registry; 29 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Female patients aged 18 years or older.
Patients scheduled to undergo total laparoscopic hysterectomy.
Patients with (ASA) physical status I-III.
Hemodynamically stable patients.
Patients with a (BMI) ≤35 kg/m².
Patients who are conscious and able to communicate verbally.
Patients who voluntarily agree to participate in the study and provide written .
Exclusion Criteria:
Patients with IV or V.
Hemodynamically unstable patients.
Infection at the planned regional block injection site.
Known allergy to local anesthetic agents or tramadol.
Patients with neuromuscular disorders or peripheral nerve diseases.
Patients with chronic pain.
History of coagulopathy or current anticoagulant therapy.
High-dose opioid use within the preceding 3 days.
History of severe hepatic or renal insufficiency.
Patients with diabetes mellitus.
Pregnant or breastfeeding patients.
Patients unable to understand or complete the Numerical Rating Scale (NRS) or Quality of Recovery-15 (QoR-15) assessments.
Patients unable to communicate in Turkish.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in this group (n=30) will receive ultrasound-guided bilateral Quadro-Iliac Plane Block (QIPB) before total laparoscopic hysterectomy. The block will be performed by an experienced anesthesiologist. All patients will receive standardized general anesthesia and postoperative multimodal analgesia according to the study protocol.
Procedure: Ultrasound-Guided Bilateral Quadro-Iliac Plane Block
Patients in this group (n=30) will receive ultrasound-guided bilateral Transversus Abdominis Plane Block (TAPB) before total laparoscopic hysterectomy. The block will be performed by an experienced anesthesiologist. All patients will receive standardized general anesthesia and postoperative multimodal analgesia according to the study protocol.
Procedure: Ultrasound-Guided Bilateral Transversus Abdominis Plane Block
Patients allocated to Group Q will receive ultrasound-guided bilateral Quadro-Iliac Plane Block (QIPB) before total laparoscopic hysterectomy. The regional block will be performed by an experienced anesthesiologist using ultrasound guidance and local anesthetic administration according to the approved study protocol. All patients will receive standardized general anesthesia and postoperative multimodal analgesia.
Patients allocated to Group T (n=30) will receive ultrasound-guided bilateral Transversus Abdominis Plane Block (TAPB) before total laparoscopic hysterectomy. Local anesthetic will be administered into the fascial plane between the internal oblique and transversus abdominis muscles under ultrasound guidance. All patients will receive standardized general anesthesia and postoperative multimodal analgesia.
Total Opioid Consumption During the First 24 Postoperative Hours
The cumulative dose of opioid analgesics administered during the first 24 hours after surgery, including tramadol delivered via patient-controlled analgesia (PCA) and rescue fentanyl, will be recorded. Total opioid consumption will be expressed in milligrams of morphine equivalents using the conversion method specified in the study protocol.
Time frame: From the end of surgery to 24 hours postoperatively.
Postoperative Pain Intensity at Rest
Pain intensity at rest will be assessed using the Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Scores will be recorded at predefined postoperative time points.
Time frame: At 0, 1, 3, 6, 12, 18, and 24 hours postoperatively.
Postoperative Pain Intensity During Movement
Pain intensity during movement from a lying to a sitting position will be assessed using the Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain).
Time frame: At 0, 1, 3, 6, 12, 18, and 24 hours postoperatively.
Quality of Recovery Assessed by QoR-15
Postoperative quality of recovery will be evaluated using the 15-item Quality of Recovery questionnaire (QoR-15). The questionnaire will be administered preoperatively and at 24 hours after surgery. Total scores range from 0 to 150, with higher scores indicating better recovery quality.
Time frame: Preoperative baseline (morning of surgery) and 24 hours postoperatively.
Sensory Block Effectiveness Assessed by Pinprick Testing
Sensory block effectiveness and distribution will be assessed bilaterally using the pinprick test in the relevant sensory areas. Responses will be scored as 0 (no pain sensation), 1 (reduced pain sensation), or 2 (normal pain sensation). Scores of 0 or 1 will indicate an effective sensory block in the assessed area.
Time frame: At 2 and 24 hours postoperatively.
Time to First Postoperative Opioid Analgesic Requirement
The elapsed time from completion of surgery to the first postoperative opioid analgesic requirement will be recorded in minutes.
Time frame: During the first 24 hours postoperatively.
Postoperative Tramadol Consumption by Time Interval
Tramadol consumption administered through patient-controlled analgesia (PCA) will be recorded in milligrams during the postoperative intervals of 0-1, 1-12, and 12-24 hours.
Time frame: During postoperative intervals of 0-1, 1-12, and 12-24 hours.
Total Rescue Fentanyl Consumption
The cumulative intravenous fentanyl dose administered as rescue analgesia for postoperative pain, when NRS is 4 or higher, will be recorded in micrograms.
Time frame: During the first 24 hours postoperatively.
Postoperative Nausea and Vomiting Severity
Postoperative nausea and vomiting (PONV) will be assessed using a four-point scale: 1 = no nausea or vomiting; 2 = nausea only; 3 = one episode of vomiting or persistent nausea; and 4 = two or more episodes of vomiting or severe or persistent retching.
Time frame: During the first 24 hours postoperatively.
No study locations are listed for this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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