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Postoperative Pain Following Total Laparoscopic HysterectomyQIPB-TAP-TLHNCT07899190

COMPARISON OF THE POSTOPERATIVE ANALGESIC EFFECTS OF ULTRASOUND-GUIDED QUADRO-ILIAC PLANE AND TRANSVERSUS ABDOMINIS PLANE BLOCKS IN PATIENTS UNDERGOING TOTAL LAPAROSCOPIC HYSTERECTOMY

A study testing Ultrasound-Guided Bilateral Quadro-Iliac Plane Block and Ultrasound-Guided Bilateral Transversus Abdominis Plane Block in people with Postoperative Pain Following Total Laparoscopic Hysterectomy, run by Hitit University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
What is being tested?
Ultrasound-Guided Bilateral Quadro-Iliac Plane Block and Ultrasound-Guided Bilateral Transversus Abdominis Plane Block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
Dec 2026to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patients aged 18 years or older.
  • Patients scheduled to undergo total laparoscopic hysterectomy.
  • Patients with American Society of Anesthesiologists (ASA) physical status I-III.
  • Hemodynamically stable patients.
  • Patients with a body mass index (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 informed consent.

Who cannot join

  • Refusal to participate in the study.
  • Patients with ASA physical status 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.
Show all 14Show fewer
  • 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.

About this study

Official title: COMPARISON OF THE POSTOPERATIVE ANALGESIC EFFICACY OF ULTRASOUND-GUIDED QUADRO-ILIAC PLANE BLOCK AND TRANSVERSUS ABDOMINIS PLANE BLOCK IN PATIENTS SCHEDULED FOR TOTAL LAPAROSCOPIC HYSTERECTOMY

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.

Read more

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.

Read the detailed description

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.

Being tested
Ultrasound-Guided Bilateral Quadro-Iliac Plane Block, Ultrasound-Guided Bilateral Transversus Abdominis Plane Block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasound-Guided Bilateral Quadro-Iliac Plane BlockProcedure or surgery

    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.

  • Ultrasound-Guided Bilateral Transversus Abdominis Plane BlockProcedure or surgery

    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.

Study groups in NCT07899190
Study groupRoleWhat they receive
Group Q: Quadro-Iliac Plane BlockExperimentalPatients 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.
Receives: Procedure: Ultrasound-Guided Bilateral Quadro-Iliac Plane Block
Group T: Transversus Abdominis Plane BlockActive comparatorPatients 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.
Receives: Procedure: Ultrasound-Guided Bilateral Transversus Abdominis Plane Block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From the end of surgery to 24 hours postoperatively.

  2. 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.

    Measured: At 0, 1, 3, 6, 12, 18, and 24 hours postoperatively.

  3. 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).

    Measured: At 0, 1, 3, 6, 12, 18, and 24 hours postoperatively.

  4. 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.

    Measured: Preoperative baseline (morning of surgery) and 24 hours postoperatively.

  5. 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.

    Measured: At 2 and 24 hours postoperatively.

  6. 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.

    Measured: During the first 24 hours postoperatively.

  7. 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.

    Measured: During postoperative intervals of 0-1, 1-12, and 12-24 hours.

  8. 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.

    Measured: During the first 24 hours postoperatively.

  9. 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.

    Measured: During the first 24 hours postoperatively.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2026
  2. Study startDec 2026 (estimated)
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07899190
Sponsor's protocol ID
HITIT-QIPB-TAP-2026
Acronym
QIPB-TAP-TLH
Status last verified
Oct 2026
First submitted
20 Oct 2026
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound-Guided Bilateral Quadro-Iliac Plane Block and Ultrasound-Guided Bilateral Transversus Abdominis Plane Block in people with Postoperative Pain Following Total Laparoscopic Hysterectomy, run by Hitit University.

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 7 inclusion and 14 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: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

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?

Total Opioid Consumption During the First 24 Postoperative Hours (time frame: From the end of surgery to 24 hours postoperatively.). The study lists 9 primary outcomes in all. 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 27 Oct 2026.

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