Postoperative PainNCT06017401
Oblique Subcostal Transversus Abdominis Plane Block Versus Transmuscular Quadratus Lumborum Block for Pain Management in Laparoscopic Gynecological Surgery
A study testing Oblique Subcostal Transversus Abdominis Plane Block and Transmuscular Quadratus Lumborum Block in people with Postoperative Pain and Surgery, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
Laparoscopic gynecological surgery causes postoperative pain.The primary objective of this study is to compare the effect of ultrasound (US)-guided oblique subcostal transversus abdominis plane block (OSTAP) on 24-hour total analgesic consumption with transmuscular quadratus lumborum block (TQLB). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Postoperative Pain, Surgery
- What is being tested?
- Oblique Subcostal Transversus Abdominis Plane Block and Transmuscular Quadratus Lumborum Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 May 2023to 29 Feb 2024
- Phase
- Interventional
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages of 18-65
- Patients who will undergo laparoscopic gynecological surgery
- ASA I-II-III patients
- Body Mass Index (BMI) in the range of 18-25 kg/m²
- Patients who will undergo surgery using 3 or 4 trocars
Who cannot join
- ASA IV-V
- Patients with a known or suspected allergy to local anesthetics
- Coagulopathy
- Injection site infection
- Severe neurological or psychiatric disorders
- Severe cardiovascular disease
Show all 10Show fewer
- Liver failure
- Kidney failure (glomerular filtration rate <15 ml/min/m²)
- Chronic opioid use (>6 months)
- Surgical durations less than 45 minutes or greater than 120 minutes
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Uludag University Faculty of Medicine
Bursa, 16059
About this study
Official title: Comparison of The Effect of Oblique Subcostal Transversus Abdominis Plane Block and Transmuscular Quadratus Lumborum Block on Postoperative Analgesia and Quality of Recovery in Patients Undergoing Laparoscopic Gynecological Surgery
Laparoscopic gynecological surgery causes postoperative pain.The primary objective of this study is to compare the effect of ultrasound (US)-guided oblique subcostal transversus abdominis plane block (OSTAP) on 24-hour total analgesic consumption with transmuscular quadratus lumborum block (TQLB).
Read the detailed description
Patients between the ages of 18-65, who will undergo laparoscopic gynecological surgery, American Society of Anesthesiologists (ASA) class I-II-III, Body Mass Index (BMI) in the range of 18-25 kg/m², and who will use 3 or 4 trocar for surgery will be included in the study. Patients will be randomized into two groups. OSTAP block will be performed for OSTAPB group and TQL block will be performed for TQLB group. Patients will be administered postoperative 4x500 mg iv paracetamol as needed (if Visual Analogue Scale (VAS) score is 4 or higher). If the VAS score remains at 4 or higher 30 minutes after paracetamol administration, 1 mg/kg iv tramadol will be administered as a rescue analgesic (with a daily maximum dose of 400 mg). The primary outcome is to compare the total analgesic consumption within the first 24 hours after surgery. The secondary outcome is to compare the time to the first postoperative analgesic requirement, VAS scores at rest and on movement, and assess the impact of these two blocks on the quality of recovery using the QOR-15 scale
- Conditions
- Postoperative Pain, Surgery
- Being tested
- Oblique Subcostal Transversus Abdominis Plane Block, Transmuscular Quadratus Lumborum Block
- Keywords
- Postoperative pain, Pain management, Oblique subcostal transversus abdominis plane block, Transmuscular quadratus lumborum block, Quality of Recovery
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oblique Subcostal Transversus Abdominis Plane BlockProcedure or surgery
The investigator will perform oblique subcostal transversus abdominis plane block to that patient group for postoperative analgesia
Transmuscular Quadratus Lumborum BlockProcedure or surgery
The investigator will perform transmuscular quadratus lumborum block to that patient group for postoperative analgesia
| Study group | Role | What they receive |
|---|---|---|
| Group OSTAP | Active comparator | The investigator will perform oblique subcostal transversus abdominis plane block to that patient group for postoperative analgesia Receives: Procedure: Oblique Subcostal Transversus Abdominis Plane Block |
| Group TQLB | Active comparator | The investigator will perform transmuscular quadratus lumborum block to that patient group for postoperative analgesia Receives: Procedure: Transmuscular Quadratus Lumborum Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative 24 hours total analgesic consumption
The primary outcome is to compare the total consumption of paracetamol and tramadol within the first 24 hours after surgery.
Measured: 24 hours postoperatively
Secondary outcomes (1)
The time to the first analgesic requirement, VAS scores and QOR-15 scores of the patients
The secondary outcomes are to compare the time to the first postoperative analgesic requirement, VAS scores at 0, 30th min and 1, 2, 6, 12, 18, 24th hours at rest and on movement, and assess the impact of these two blocks on the quality of recovery using the QoR-15 scale.
A visual analogue scale (VAS) requires the patient to rate their pain on a scale of 0-10, where 0 represents no pain and 10 represents the worst pain imaginable.
The QoR-15 scale is a unidimensional measurement of quality of recovery measured in five domains: physical comfort, pain, physical independence, psychological support, and emotional state. The QoR-15 scale provides a score ranging from 0 to 150, with a high score indicating a good quality of recovery.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start22 May 2023
- Primary completion27 Nov 2023
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Cebeci, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06017401
- Sponsor's protocol ID
- UludagU-KCebeci-001
- Status last verified
- Mar 2024
- First submitted
- 20 Aug 2023
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cebeci K, Akesen S, Cansabuncu S, Gurbet A, Uncu G. Oblique subcostal transversus abdominis plane block versus transmuscular quadratus lumborum block for postoperative analgesia and quality of recovery in laparoscopic gynecological surgery: a prospective randomized controlled double-blind trial. BMC Anesthesiol. 2026 Jan 24;26(1):90. doi: 10.1186/s12871-026-03643-z.
PubMed 41580664
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of The Effect of Oblique Subcostal Transversus Abdominis Plane Block and Transmuscular Quadratus Lumborum Block on Postoperative Analgesia and Quality of Recovery in Patients Undergoing Laparoscopic Gynecological Surgery
- ClinicalTrials.gov ID
- NCT06017401
- Acronym / sponsor ID
- UludagU-KCebeci-001
- Conditions
- Postoperative Pain, Surgery
- Keywords
- Postoperative pain, Pain management, Oblique subcostal transversus abdominis plane block, Transmuscular quadratus lumborum block, Quality of Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 22 May 2023 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 30 Aug 2023 (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.
Laparoscopic gynecological surgery causes postoperative pain.The primary objective of this study is to compare the effect of ultrasound (US)-guided oblique subcostal transversus abdominis plane block (OSTAP) on 24-hour total analgesic consumption with transmuscular quadratus lumborum block (TQLB).
Detailed description
Patients between the ages of 18-65, who will undergo laparoscopic gynecological surgery, American Society of Anesthesiologists (ASA) class I-II-III, Body Mass Index (BMI) in the range of 18-25 kg/m², and who will use 3 or 4 trocar for surgery will be included in the study. Patients will be randomized into two groups. OSTAP block will be performed for OSTAPB group and TQL block will be performed for TQLB group. Patients will be administered postoperative 4x500 mg iv paracetamol as needed (if Visual Analogue Scale (VAS) score is 4 or higher). If the VAS score remains at 4 or higher 30 minutes after paracetamol administration, 1 mg/kg iv tramadol will be administered as a rescue analgesic (with a daily maximum dose of 400 mg). The primary outcome is to compare the total analgesic consumption within the first 24 hours after surgery. The secondary outcome is to compare the time to the first postoperative analgesic requirement, VAS scores at rest and on movement, and assess the impact of these two blocks on the quality of recovery using the QOR-15 scale
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group OSTAP | Active comparator | Procedure: Oblique Subcostal Transversus Abdominis Plane BlockThe investigator will perform oblique subcostal transversus abdominis plane block to that patient group for postoperative analgesia |
| Group TQLB | Active comparator | Procedure: Transmuscular Quadratus Lumborum BlockThe investigator will perform transmuscular quadratus lumborum block to that patient group for postoperative analgesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ages of 18-65
- Patients who will undergo laparoscopic gynecological surgery
- ASA I-II-III patients
- Body Mass Index (BMI) in the range of 18-25 kg/m²
- Patients who will undergo surgery using 3 or 4 trocars
Key exclusion criteria (10 listed)
- ASA IV-V
- Patients with a known or suspected allergy to local anesthetics
- Coagulopathy
- Injection site infection
- Severe neurological or psychiatric disorders
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 |
|---|---|---|
| Oblique Subcostal Transversus Abdominis Plane BlockThe investigator will perform oblique subcostal transversus abdominis plane block to that patient group for postoperative analgesia | Procedure or surgery | Group OSTAP |
| Transmuscular Quadratus Lumborum BlockThe investigator will perform transmuscular quadratus lumborum block to that patient group for postoperative analgesia | Procedure or surgery | Group TQLB |
Primary outcome
Postoperative 24 hours total analgesic consumption
Time frame: 24 hours postoperatively
The primary outcome is to compare the total consumption of paracetamol and tramadol within the first 24 hours after surgery.
1 secondary outcome
The time to the first analgesic requirement, VAS scores and QOR-15 scores of the patients
Time frame: 24 hours postoperatively
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 6 Mar 2024.
- Derived from this study: PubMed 41580664Cebeci K, Akesen S, Cansabuncu S, Gurbet A, Uncu G. Oblique subcostal transversus abdominis plane block versus transmuscular quadratus lumborum block for postoperative analgesia and quality of recovery in laparoscopic gynecological surgery: a prospective randomized controlled double-blind trial. BMC Anesthesiol. 2026 Jan 24;26(1):90. doi: 10.1186/s12871-026-03643-z.
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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?
A study testing Oblique Subcostal Transversus Abdominis Plane Block and Transmuscular Quadratus Lumborum Block in people with Postoperative Pain and Surgery, run by Uludag 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 5 inclusion and 10 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 6 Mar 2024. 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 24 hours total analgesic consumption (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06017401, which also lists 1 linked publication.
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 6 Mar 2024.