Postoperative PainNCT05943015
Analgesic Efficacy of Quadratus Lumborum, Paravertebral Blocks
A study testing Quadratus Lumborum Block II, Quadratus Lumborum Block III and Paravertebral Block in people with Postoperative Pain, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
This trial is a prospective, randomized, single-center, single blinded-analysis trial, the objective of which is compare the postoperative analgesia efficacy of Quadratus lumborum II, Quadratus Lumborum III and Paravertebral blocks in elective laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Quadratus Lumborum Block II, Quadratus Lumborum Block III and Paravertebral Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Sep 2022to 15 Dec 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years, American Society of Anesthesiologists physical statusⅠ-II
Who cannot join
- local anesthetic allergy
- Infection at the procedure site
- Body Mass Index >35 kg/m2
- Anticoagulant use with bleeding disorder
- Chronic analgesia and opioid use
- with mental and psychiatric disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa Resarch and Education Hospital
Istanbul, 34255
About this study
Official title: Comparison of Postoperative Analgesic Efficacy of Quadratus Lumborum II, Quadratus Lumborum III and Paravertebral Blocks in Elective Laparoscopic Cholecystectomies
This trial is a prospective, randomized, single-center, single blinded-analysis trial, the objective of which is compare the postoperative analgesia efficacy of Quadratus lumborum II, Quadratus Lumborum III and Paravertebral blocks in elective laparoscopic cholecystectomy.
Read the detailed description
Laparoscopic approach in cholecystectomy surgery is frequently preferred because of its advantages in systemic complications, morbidity, mortality and hospital stay. Pain is one of the important causes of late discharge after surgery. Laparoscopic cholecystectomy surgery requires a multimodal analgesia approach because of its multiple pain components.Regional analgesia techniques are effective in reducing the side effects such as intraoperative opioid use, postoperative pain and nausea and vomiting. Quadratus lumborum block and paravertebral plane blocks are regional techniques performed for multimodal analgesia.
The aim of this study is to determine an effective analgesia method by comparing the postoperative analgesic effectiveness of Quadratus Lumborum II, Quadratus Lumborum III and Paravertebral blocks in elective laparoscopic cholecystectomy surgery.
- Conditions
- Postoperative Pain
- Being tested
- Quadratus Lumborum Block II, Patient controlled intravenous analgesia, Quadratus Lumborum Block III, Paravertebral Block
- Keywords
- paravertebral block, quadratus lumborum block, laparoscopic cholecystectomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadratus Lumborum Block IIProcedure or surgery
Patients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the psoas major and the transverse process adjacent to the quadratus lumborum muscle, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle negative aspiration into the middle layer of the thoracolumbar fascia posterior to the quadratus lumborum muscle, then 0.5-1 ml of saline 20 ml of 0.25% bupivacaine will be injected after hydrodissection is observed. The same will be done to the other side.
Patient controlled intravenous analgesiaDrug
Afterward of the operation, patients will be treated with patient-controlled analgesia with intravenous tramadol, with 20 mg bolus 20 minutes lock time, 4-hour limit 100 mg and 24-hour limit 400 mg
Quadratus Lumborum Block IIIProcedure or surgery
Patients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the transverse process adjacent to the psoas major and quadratus lumborum muscles, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle after negative aspiration into the anterior layer of the thoracolumbar fascia anterior to the quadratus lumborum muscle muscle, 0.5-1 ml of serum After observing hydrodissection with physiological, 20 ml of 0.25% bupivacaine is injected. The same is done to the opposite side.
Patient controlled intravenous analgesiaDrug
Afterward of the operation, patients will be treated with patient-controlled analgesia with intravenous tramadol, with 20 mg bolus 20 minutes lock time, 4-hour limit 100 mg and 24-hour limit 400 mg
Paravertebral BlockProcedure or surgery
Patients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. The linear ultrasound probe is placed longitudinally at the T6 level, 2-2.5 cm lateral to the spinous processes. Transverse process, superior costotransverse ligament and pleura are visualized, 22 gauge 80 mm peripheral block needle is passed with in-plane technique, superior costotransverse ligament is passed, negative aspiration into the paravertebral space under the ligament, followed by 0.5-1 ml of saline and hydrodissection of the pleura, followed by 20 ml of 0.25% bupivacaine is injected.The same is done to the opposite side.
Patient controlled intravenous analgesiaDrug
Afterward of the operation, patients will be treated with patient-controlled analgesia with intravenous tramadol, with 20 mg bolus 20 minutes lock time, 4-hour limit 100 mg and 24-hour limit 400 mg
| Study group | Role | What they receive |
|---|---|---|
| Quadratus Lumborum Block II | Active comparator | Quadratus Lumborum Block II Receives: Procedure: Quadratus Lumborum Block II; Drug: Patient controlled intravenous analgesia |
| Quadratus Lumborum Block III | Active comparator | Quadratus Lumborum Block III Receives: Procedure: Quadratus Lumborum Block III; Drug: Patient controlled intravenous analgesia |
| Paravertebral Block | Active comparator | Paravertebral Block Receives: Procedure: Paravertebral Block; Drug: Patient controlled intravenous analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of tramadol use
The total tramadol use of the patients in 24 hours will be recorded.
Measured: within 24 hours after the surgery
Secondary outcomes (5)
Visual Analogue Scale values at 1st, 6th, 12th and 24th hours
Visual Analogue Scale is a scale of 0-10 cm in length, expressed by non-standard verbal descriptors (no pain-unbearable pain..) indicating the limits of pain intensity on both sides, horizontally or vertically.
Measured: at 1st, 6th, 12th and 24th hours after the surgery
Block onset time
In order to evaluate sensory block, dermatome involvement will be evaluated with ice between Thoracic 1 and Lumbar 5 levels. When the feeling of coldness disappears, dermatome involvement will be considered. The sensory block formation time with ice will be evaluated as the block onset time, the10th, 20th and 30th minute dermatome area involvement will be recorded.
Measured: 30 min after the block
intraoperative remifentanil consumption
The total remifentanil use to be used in the maintenance of 0.05-0.2 mcg/kg remifentanil will be recorded by titration according to the hemodynamic data of the intraoperative patients.
Measured: during operation procedure
postoperative length of hospital stay
time to patient's discharge
Measured: within 1 weeks after the surgery
side effects such as nausea, vomiting and shoulder pain
The incidence of postoperative side effects such as nausea, vomiting and shoulder pain will be evaluated.
Measured: within 24 hours after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start5 Sep 2022
- Primary completion1 Dec 2024
- Study completion15 Dec 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- EMINE KOSE, Principal investigator, Gaziosmanpasa Research and Education HospitalDONDU GENC MORALAR, Principal investigator, Gaziosmanpasa Research and Education HospitalSERPIL SAHIN SEHIRLIOGLU, Principal investigator, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943015
- Sponsor's protocol ID
- GaziosmanpasaTREHEK
- Status last verified
- Jul 2024
- First submitted
- 21 Jun 2023
- Last updated
- 15 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang J, Cui X, Ren L, Li X, Zhang Y, Xie Y, Ji Z, Huang Y. Comparison of the Postoperative Analgesic Effects between Ultrasound-Guided Transmuscular Quadratus Lumborum Block and Thoracic Paravertebral Block in Laparoscopic Partial Nephrectomy Patients: A Randomized, Controlled, and Noninferiority Study. Pain Res Manag. 2023 Feb 20;2023:8652596. doi: 10.1155/2023/8652596. eCollection 2023.
PubMed 36891030
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Analgesic Efficacy of Quadratus Lumborum II, Quadratus Lumborum III and Paravertebral Blocks in Elective Laparoscopic Cholecystectomies
- ClinicalTrials.gov ID
- NCT05943015
- Acronym / sponsor ID
- GaziosmanpasaTREHEK
- Conditions
- Postoperative Pain
- Keywords
- paravertebral block, quadratus lumborum block, laparoscopic cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 12 Jul 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.
This trial is a prospective, randomized, single-center, single blinded-analysis trial, the objective of which is compare the postoperative analgesia efficacy of Quadratus lumborum II, Quadratus Lumborum III and Paravertebral blocks in elective laparoscopic cholecystectomy.
Detailed description
Laparoscopic approach in cholecystectomy surgery is frequently preferred because of its advantages in systemic complications, morbidity, mortality and hospital stay. Pain is one of the important causes of late discharge after surgery. Laparoscopic cholecystectomy surgery requires a multimodal analgesia approach because of its multiple pain components.Regional analgesia techniques are effective in reducing the side effects such as intraoperative opioid use, postoperative pain and nausea and vomiting. Quadratus lumborum block and paravertebral plane blocks are regional techniques performed for multimodal analgesia.
The aim of this study is to determine an effective analgesia method by comparing the postoperative analgesic effectiveness of Quadratus Lumborum II, Quadratus Lumborum III and Paravertebral blocks in elective laparoscopic cholecystectomy surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Quadratus Lumborum Block II | Active comparator | Procedure: Quadratus Lumborum Block II, Drug: Patient controlled intravenous analgesiaQuadratus Lumborum Block II |
| Quadratus Lumborum Block III | Active comparator | Procedure: Quadratus Lumborum Block III, Drug: Patient controlled intravenous analgesiaQuadratus Lumborum Block III |
| Paravertebral Block | Active comparator | Procedure: Paravertebral Block, Drug: Patient controlled intravenous analgesiaParavertebral Block |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18-65 years, American Society of Anesthesiologists physical statusⅠ-II
Key exclusion criteria (6 listed)
- local anesthetic allergy
- Infection at the procedure site
- Body Mass Index >35 kg/m2
- Anticoagulant use with bleeding disorder
- Chronic analgesia and opioid use
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 |
|---|---|---|
| Quadratus Lumborum Block IIPatients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the psoas major and the transverse process adjacent to the quadratus lumborum muscle, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle negative aspiration into the middle layer of the thoracolumbar fascia posterior to the quadratus lumborum muscle, then 0.5-1 ml of saline 20 ml of 0.25% bupivacaine will be injected after hydrodissection is observed. The same will be done to the other side. | Procedure or surgery | Quadratus Lumborum Block II |
| Patient controlled intravenous analgesiaAfterward of the operation, patients will be treated with patient-controlled analgesia with intravenous tramadol, with 20 mg bolus 20 minutes lock time, 4-hour limit 100 mg and 24-hour limit 400 mg | Drug | Quadratus Lumborum Block II |
| Quadratus Lumborum Block IIIPatients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the transverse process adjacent to the psoas major and quadratus lumborum muscles, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle after negative aspiration into the anterior layer of the thoracolumbar fascia anterior to the quadratus lumborum muscle muscle, 0.5-1 ml of serum After observing hydrodissection with physiological, 20 ml of 0.25% bupivacaine is injected. The same is done to the opposite side. | Procedure or surgery | Quadratus Lumborum Block III |
| Patient controlled intravenous analgesiaAfterward of the operation, patients will be treated with patient-controlled analgesia with intravenous tramadol, with 20 mg bolus 20 minutes lock time, 4-hour limit 100 mg and 24-hour limit 400 mg | Drug | Quadratus Lumborum Block III |
| Paravertebral BlockPatients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. The linear ultrasound probe is placed longitudinally at the T6 level, 2-2.5 cm lateral to the spinous processes. Transverse process, superior costotransverse ligament and pleura are visualized, 22 gauge 80 mm peripheral block needle is passed with in-plane technique, superior costotransverse ligament is passed, negative aspiration into the paravertebral space under the ligament, followed by 0.5-1 ml of saline and hydrodissection of the pleura, followed by 20 ml of 0.25% bupivacaine is injected.The same is done to the opposite side. | Procedure or surgery | Paravertebral Block |
| Patient controlled intravenous analgesiaAfterward of the operation, patients will be treated with patient-controlled analgesia with intravenous tramadol, with 20 mg bolus 20 minutes lock time, 4-hour limit 100 mg and 24-hour limit 400 mg | Drug | Paravertebral Block |
Primary outcome
Total amount of tramadol use
Time frame: within 24 hours after the surgery
The total tramadol use of the patients in 24 hours will be recorded.
5 secondary outcomes
Visual Analogue Scale values at 1st, 6th, 12th and 24th hours
Time frame: at 1st, 6th, 12th and 24th hours after the surgery
Block onset time
Time frame: 30 min after the block
intraoperative remifentanil consumption
Time frame: during operation procedure
postoperative length of hospital stay
Time frame: within 1 weeks after the surgery
side effects such as nausea, vomiting and shoulder pain
Time frame: within 24 hours after the 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 15 Jul 2025.
- Background: PubMed 36891030Wang J, Cui X, Ren L, Li X, Zhang Y, Xie Y, Ji Z, Huang Y. Comparison of the Postoperative Analgesic Effects between Ultrasound-Guided Transmuscular Quadratus Lumborum Block and Thoracic Paravertebral Block in Laparoscopic Partial Nephrectomy Patients: A Randomized, Controlled, and Noninferiority Study. Pain Res Manag. 2023 Feb 20;2023:8652596. doi: 10.1155/2023/8652596. eCollection 2023.
- 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.
EMINE KOSE principal investigator
Gaziosmanpasa Research and Education Hospital
DONDU GENC MORALAR principal investigator
Gaziosmanpasa Research and Education Hospital
SERPIL SAHIN SEHIRLIOGLU principal investigator
Gaziosmanpasa Research and Education Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quadratus Lumborum Block II, Quadratus Lumborum Block III and Paravertebral Block in people with Postoperative Pain, run by Gaziosmanpasa Research and Education 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 6 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 15 Jul 2025. 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?
Total amount of tramadol use (time frame: within 24 hours after the surgery). 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 NCT05943015, 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 15 Jul 2025.