Laparoscopic CholecystectomyA Two-CenterNCT06666231
Comparison of Ultrasound-Guided Quadratus Lumborum Plane Block and External Oblique Intercostal Plane Block for Postoperative Analgesia After Laparoscopic Cholecystectomy: a Two-Center Randomized Controlled Trial
A study testing QL (quadratus lumborum) block administration and External Oblique Intercostal Plane Block in people with Laparoscopic Cholecystectomy, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of this study was to compare the postoperative analgesic efficacy of the Anterior Quadratus Lumborum Plane Block and the External Oblique Intercostal Plane Blocks used in laparoscopic cholecystectomy surgeries. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- QL (quadratus lumborum) block administration and External Oblique Intercostal Plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Oct 2024to 30 Nov 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who will undergo laparoscopic cholecystectomy and who meet the ASA I-II risk classification between the ages of 18-65 will be included.
Who cannot join
- Patients who do not agree to participate in the study, who have an infection in the application area, who are allergic to local anesthesia, who have coagulopathy, who are morbidly obese (Body mass index (BMI)>35), who have a history of drug allergy, chronic pain, long-term opioid use and psychiatric illness, and who require emergency surgery are excluded from the study. will be left
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Sciences University Gazi Yaşargil Training and Research Hospital
Diyarbakır, kayapınar, 21070
About this study
Official title: A Two-Center Randomized Controlled Trial
The primary aim of this study was to compare the postoperative analgesic efficacy of the Anterior Quadratus Lumborum Plane Block and the External Oblique Intercostal Plane Blocks used in laparoscopic cholecystectomy surgeries.
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- QL (quadratus lumborum) block administration, External Oblique Intercostal Plane Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL (quadratus lumborum) block administrationProcedure or surgery
After endotracheal intubation, patients in the supine position will be given a lateral tilt and the areas to be treated will be cleaned with surgical antiseptic solution. The convex USG probe will be covered in a sterile manner. Then, the sterile probe will be placed transversely on the crista iliaca. The probe will be directed cranially until the external oblique muscle, internal oblique muscle and transverse abdominis muscle are clearly visualized. The psoas major muscle and the transverse process of the vertebra will be visualized. The QL muscle will be visualized between the aponeuros of the transverse abdominis muscle and the psoas major muscle. A 20 G 100 mm block needle will be advanced from posterolateral to anteromedial using the "in-plane" technique. The needle will be directed between the QL muscle and the psoas major muscles. 20 ml of 0.25% bupivacaine (Buvasin®, Vem İlaç, Turkey) will be injected on each side between the fasciae of these two muscles and the LA distribution
External Oblique Intercostal Plane BlockProcedure or surgery
After endotracheal intubation, a 20-gauge 100 mm long block needle will be inserted at the T6-T7 level under USG guidance and bilateral EOIB will be applied with 20 cc of 0.25% Bupivacaine on each side under the external oblique intercostal muscle (total 40ml bilaterally).
| Study group | Role | What they receive |
|---|---|---|
| Anterior Quadratus Lumborum Plane Block | Active comparator | After endotracheal intubation, patients in the supine position will be given a lateral tilt and the areas to be treated will be cleaned with surgical antiseptic solution. The convex USG probe will be covered in a sterile manner. Then, the sterile probe will be placed transversely on the crista iliaca. The probe will be directed cranially until the external oblique muscle, internal oblique muscle and transverse abdominis muscle are clearly visualized. The psoas major muscle and the transverse process of the vertebra will be visualized. The QL muscle will be visualized between the aponeuros of the transverse abdominis muscle and the psoas major muscle. A 20 G 100 mm block needle will be advanced from posterolateral to anteromedial using the "in-plane" technique. The needle will be directed between the QL muscle and the psoas major muscles. 20 ml of 0.25% bupivacaine (Buvasin®, Vem İlaç, Turkey) will be injected on each side between the fasciae of these two muscles and the LA distributio Receives: Procedure: QL (quadratus lumborum) block administration |
| External Oblique Intercostal Plane Block | Active comparator | After endotracheal intubation, a 20-gauge 100 mm long block needle will be inserted at the T6-T7 level under USG guidance and bilateral EOIB will be applied with 20 cc of 0.25% Bupivacaine on each side under the external oblique intercostal muscle (total 40ml bilaterally). Receives: Procedure: External Oblique Intercostal Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale
They will be numbered from 1 to 10. If reporting a score on a scale, please include the unabbreviated scale title, the minimum and maximum values, and whether higher scores mean a better or worse outcome
Measured: Postoperative 30.second,2 hours, 4 hours,12 hours,24 hours
Secondary outcomes (3)
Opioid use
tramadol use
Measured: postoperative 24 hours
Riker Sedation Agitation Scale
7 Dangerous Agitation ... If reporting a score on a scale, please include the unabbreviated scale title, the minimum and maximum values, and whether higher scores mean a better or worse outcome.
Measured: Immediately after extubation
Patient satisfaction score
Patients' satisfaction with the quality of pain management will be evaluated on the second postoperative day using the following scale: 1 = very unsatisfied; 2 = highly dissatisfied; 3 = medium; 4 = very satisfactory; 5 = very satisfactory
Measured: at the 24th postoperative hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start29 Oct 2024
- Primary completion26 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hülya Tosun Söner, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06666231
- Sponsor's protocol ID
- HTSsONER
- Acronym
- A Two-Center
- Status last verified
- Dec 2024
- First submitted
- 29 Oct 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06666231
- Acronym / sponsor ID
- A Two-Center / HTSsONER
- Conditions
- Laparoscopic Cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalUniversity, hospital or other
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- 26 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 30 Oct 2024 (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 primary aim of this study was to compare the postoperative analgesic efficacy of the Anterior Quadratus Lumborum Plane Block and the External Oblique Intercostal Plane Blocks used in laparoscopic cholecystectomy surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior Quadratus Lumborum Plane Block | Active comparator | Procedure: QL (quadratus lumborum) block administrationAfter endotracheal intubation, patients in the supine position will be given a lateral tilt and the areas to be treated will be cleaned with surgical antiseptic solution. The convex USG probe will be covered in a sterile manner. Then, the sterile probe will be placed transversely on the crista iliaca. The probe will be directed cranially until the external oblique muscle, internal oblique muscle and transverse abdominis muscle are clearly visualized. The psoas major muscle and the transverse process of the vertebra will be visualized. The QL muscle will be visualized between the aponeuros of the transverse abdominis muscle and the psoas major muscle. A 20 G 100 mm block needle will be advanced from posterolateral to anteromedial using the "in-plane" technique. The needle will be directed between the QL muscle and the psoas major muscles. 20 ml of 0.25% bupivacaine (Buvasin®, Vem İlaç, Turkey) will be injected on each side between the fasciae of these two muscles and the LA distributio |
| External Oblique Intercostal Plane Block | Active comparator | Procedure: External Oblique Intercostal Plane BlockAfter endotracheal intubation, a 20-gauge 100 mm long block needle will be inserted at the T6-T7 level under USG guidance and bilateral EOIB will be applied with 20 cc of 0.25% Bupivacaine on each side under the external oblique intercostal muscle (total 40ml bilaterally). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who will undergo laparoscopic cholecystectomy and who meet the ASA I-II risk classification between the ages of 18-65 will be included.
Key exclusion criteria (2 listed)
- Patients who do not agree to participate in the study, who have an infection in the application area, who are allergic to local anesthesia, who have coagulopathy, who are morbidly obese (Body mass index (BMI)>35), who have a history of drug allergy, chronic pain, long-term opioid use and psychiatric illness, and who require emergency surgery are excluded from the study. will be left
- -
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 |
|---|---|---|
| QL (quadratus lumborum) block administrationAfter endotracheal intubation, patients in the supine position will be given a lateral tilt and the areas to be treated will be cleaned with surgical antiseptic solution. The convex USG probe will be covered in a sterile manner. Then, the sterile probe will be placed transversely on the crista iliaca. The probe will be directed cranially until the external oblique muscle, internal oblique muscle and transverse abdominis muscle are clearly visualized. The psoas major muscle and the transverse process of the vertebra will be visualized. The QL muscle will be visualized between the aponeuros of the transverse abdominis muscle and the psoas major muscle. A 20 G 100 mm block needle will be advanced from posterolateral to anteromedial using the "in-plane" technique. The needle will be directed between the QL muscle and the psoas major muscles. 20 ml of 0.25% bupivacaine (Buvasin®, Vem İlaç, Turkey) will be injected on each side between the fasciae of these two muscles and the LA distribution | Procedure or surgery | Anterior Quadratus Lumborum Plane Block |
| External Oblique Intercostal Plane BlockAfter endotracheal intubation, a 20-gauge 100 mm long block needle will be inserted at the T6-T7 level under USG guidance and bilateral EOIB will be applied with 20 cc of 0.25% Bupivacaine on each side under the external oblique intercostal muscle (total 40ml bilaterally). | Procedure or surgery | External Oblique Intercostal Plane Block |
Primary outcome
Numeric Rating Scale
Time frame: Postoperative 30.second,2 hours, 4 hours,12 hours,24 hours
They will be numbered from 1 to 10. If reporting a score on a scale, please include the unabbreviated scale title, the minimum and maximum values, and whether higher scores mean a better or worse outcome
3 secondary outcomes
Opioid use
Time frame: postoperative 24 hours
Riker Sedation Agitation Scale
Time frame: Immediately after extubation
Patient satisfaction score
Time frame: at the 24th postoperative hour
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 4 Dec 2024.
- Individual participant dataSharing planned: No
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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 QL (quadratus lumborum) block administration and External Oblique Intercostal Plane Block in people with Laparoscopic Cholecystectomy, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital 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 1 inclusion and 2 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 4 Dec 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?
Numeric Rating Scale (time frame: Postoperative 30.second,2 hours, 4 hours,12 hours,24 hours). 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 4 Dec 2024; AzTrials last refreshed its copy on 8 Nov 2026.