Postoperative PainPhase 4NCT02783586
TAPB vs QLBII for Kidney Transplantation Procedure
A Phase 4 study testing Quadratus Lumborum Block type II, Transversus Abdominalis Plane Block and Bupivacaine in people with Postoperative Pain, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The main advantage of Quadratus Lumborum Block (QLB) compared to Transversus Abdominalis Plane Block (TAPB) is the impact on visceral pain due to the spread of the local anaesthetic agent to the paravertebral space. It may produce extensive analgesia and better pain control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Quadratus Lumborum Block type II, Transversus Abdominalis Plane Block and Bupivacaine
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 sitePoland
- Study dates
- 8 Apr 2016to 30 May 2017
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Kidney transplantation procedure with anatomical urinary outlet
- Written informed consent
Who cannot join
- Patients' refusal
- Known allergies to study medication
- Inability to comprehend or participate in pain scoring scale
- Inability to use intravenous patient controlled analgesia system
- Anatomic, posttraumatic and postoperative deformations could possibly affect the spread of local anesthetic in transversus abdominalis plane or quadratus lumborum muscle plane.
- Transversus abdominalis plane or quadratus lumborum muscle plane not seen in ultrasound examination.
Trial locations and contacts
1 site in 1 country.
Poland1 site
I Department of Anaesthesiology and Intensive Care, Medical University of Warsaw
Warsaw, 02-005
About this study
Official title: Ultrasound Guided Transversus Abdominalis Plane Block ( TAPB) Versus Quadratus Lumborum Type II Block (QLBII) in Perioperative Analgesia for Kidney Transplantation Procedure: Clinical Randomized Multicenter Study
The main advantage of Quadratus Lumborum Block (QLB) compared to Transversus Abdominalis Plane Block (TAPB) is the impact on visceral pain due to the spread of the local anaesthetic agent to the paravertebral space. It may produce extensive analgesia and better pain control.
Previews studies shoved the effectiveness of TAPB in kidney transplantation procedure (KTX) by reducing opioids requirements during and after the operation. QLB was not evaluating in KTX procedure yet, but it reduced postoperative morphine requirement after cesarean section under spinal anaesthesia.
The aim of this prospective, randomised controlled, multicenter, clinical study is to compare the perioperative analgesic efficacy of QLB and TAPB in patients who had KTX under balanced (general and regional) anaesthesia.
Read the detailed description
After Bioethical Committee of Medical University of Warsaw approval, informed written consent will be obtained from all patients.
A sample size of 104 patients was calculated to obtain at list 25% reduction of fentanyl usage in QLBII group with 0,05% significance and power of 0,8. Consenting patients, scheduled to KTX procedure under general anaesthesia will be randomly assigned (1:1) according to the computer -generated randomization list with permuted blocks (block sizes: 20, 20, 24, 40) to receive 20ml of 0,25% Bupivacaine with epinephrine ipsilaterally to the operation side in QLBII or TAPB after the general anaesthesia induction and before the surgery starts. All the blocks will be performed in the supine patients position, under ultrasound guidance for both techniques. The correct spread of injectate will be confirmed with ultrasound.
- Conditions
- Postoperative Pain
- Being tested
- Quadratus Lumborum Block type II, Transversus Abdominalis Plane Block, Bupivacaine, Ultraplex
- 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 type IIProcedure or surgery
Local anaesthetic injection on the posterior border of the quadratus lumborum muscle
Transversus Abdominalis Plane BlockProcedure or surgery
Local anaesthetic injection between internal oblique and transversus abdominis muscle
BupivacaineDrug
Also called Marcaine
20 ml of bupivacaine with adrenaline
UltraplexDevice
A non-stimulating echogenic single-shot needle designed for regional analgesia under ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| Quadratus Lumborum Block type II | Experimental | Unilateral ultrasound guidance QLB on the operated side after induction of general anaesthesia - 20 ml of 0,25%bupivacaine with adrenaline injected with ultraplex needle Receives: Procedure: Quadratus Lumborum Block type II; Drug: Bupivacaine; Device: Ultraplex |
| Transversus Abdominalis Plane Block | Active comparator | Unilateral ultrasound guidance TAPB on the operated side after induction of general anaesthesia - 20 ml of 0,25% bupivacaine with adrenaline injected with ultraplex needle Receives: Procedure: Transversus Abdominalis Plane Block; Drug: Bupivacaine; Device: Ultraplex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total postoperative fentanyl usage
Total cumulative fentanyl dose used in the first 24 hours after surgery
Measured: 24 hours
Secondary outcomes (4)
Time to first analgesic (TTFA)
Time from the end of surgery to the first postoperative intravenous fentanyl administered from intravenous patient controlled analgesia ( IVPCA) device.
Measured: 24 hours
Postoperative pain severity in Numerical Rating Scale (NRS) in the first 24 hours after surgery
NRS range from 0 for no pain to 10 for worst pain imaginable.
Measured: 24 hours
Nausea or vomiting
0- no nausea; 1- mild nausea; 2- moderate nausea; 3- severe nausea or vomiting
Measured: 24 hours
Sedation Level
1 - responds to normal verbal communication; 2 - drowsy, but responds to verbal communication; 3- asleep, but awakes with verbal communication; 4- asleep, awakens with mild physical stimulation. 5- asleep, unresponsive to physical stimulation.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study start8 Apr 2016
- Primary completion29 May 2017
- Study completion30 May 2017
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.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcin Kołacz, Medical University of Warsaw
- Investigators
- Marcin Kolacz, MD,PhD, Study director, Medical University of WarsawMarcin Mieszkowski, MD, Principal investigator, Faculty of Medical Sciences, University of Warmia and Mazury in Olsztyn, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02783586
- Sponsor's protocol ID
- TAPB/QLB-WAW/OLS
- Status last verified
- May 2018
- First submitted
- 18 May 2016
- Last updated
- 22 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kolacz M, Mieszkowski M, Janiak M, Zagorski K, Byszewska B, Weryk-Dysko M, Onichimowski D, Trzebicki J. Transversus abdominis plane block versus quadratus lumborum block type 2 for analgesia in renal transplantation: A randomised trial. Eur J Anaesthesiol. 2020 Sep;37(9):773-789. doi: 10.1097/EJA.0000000000001193.
PubMed 32175985
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Transversus Abdominalis Plane Block ( TAPB) Versus Quadratus Lumborum Type II Block (QLBII) in Perioperative Analgesia for Kidney Transplantation Procedure: Clinical Randomized Multicenter Study
- ClinicalTrials.gov ID
- NCT02783586
- Acronym / sponsor ID
- TAPB/QLB-WAW/OLS
- Conditions
- Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 8 Apr 2016 (actual)
- Primary completion
- 29 May 2017 (actual)
- Study completion
- 30 May 2017 (actual)
- First posted
- 26 May 2016 (estimated)
- 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 main advantage of Quadratus Lumborum Block (QLB) compared to Transversus Abdominalis Plane Block (TAPB) is the impact on visceral pain due to the spread of the local anaesthetic agent to the paravertebral space. It may produce extensive analgesia and better pain control.
Previews studies shoved the effectiveness of TAPB in kidney transplantation procedure (KTX) by reducing opioids requirements during and after the operation. QLB was not evaluating in KTX procedure yet, but it reduced postoperative morphine requirement after cesarean section under spinal anaesthesia.
The aim of this prospective, randomised controlled, multicenter, clinical study is to compare the perioperative analgesic efficacy of QLB and TAPB in patients who had KTX under balanced (general and regional) anaesthesia.
Detailed description
After Bioethical Committee of Medical University of Warsaw approval, informed written consent will be obtained from all patients.
A sample size of 104 patients was calculated to obtain at list 25% reduction of fentanyl usage in QLBII group with 0,05% significance and power of 0,8. Consenting patients, scheduled to KTX procedure under general anaesthesia will be randomly assigned (1:1) according to the computer -generated randomization list with permuted blocks (block sizes: 20, 20, 24, 40) to receive 20ml of 0,25% Bupivacaine with epinephrine ipsilaterally to the operation side in QLBII or TAPB after the general anaesthesia induction and before the surgery starts. All the blocks will be performed in the supine patients position, under ultrasound guidance for both techniques. The correct spread of injectate will be confirmed with ultrasound.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadratus Lumborum Block type II | Experimental | Procedure: Quadratus Lumborum Block type II, Drug: Bupivacaine, Device: UltraplexUnilateral ultrasound guidance QLB on the operated side after induction of general anaesthesia - 20 ml of 0,25%bupivacaine with adrenaline injected with ultraplex needle |
| Transversus Abdominalis Plane Block | Active comparator | Procedure: Transversus Abdominalis Plane Block, Drug: Bupivacaine, Device: UltraplexUnilateral ultrasound guidance TAPB on the operated side after induction of general anaesthesia - 20 ml of 0,25% bupivacaine with adrenaline injected with ultraplex needle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Kidney transplantation procedure with anatomical urinary outlet
- Written informed consent
Key exclusion criteria (6 listed)
- Patients' refusal
- Known allergies to study medication
- Inability to comprehend or participate in pain scoring scale
- Inability to use intravenous patient controlled analgesia system
- Anatomic, posttraumatic and postoperative deformations could possibly affect the spread of local anesthetic in transversus abdominalis plane or quadratus lumborum muscle plane.
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 type IILocal anaesthetic injection on the posterior border of the quadratus lumborum muscle | Procedure or surgery | Quadratus Lumborum Block type II |
| Transversus Abdominalis Plane BlockLocal anaesthetic injection between internal oblique and transversus abdominis muscle | Procedure or surgery | Transversus Abdominalis Plane Block |
| BupivacaineAlso: Marcaine20 ml of bupivacaine with adrenaline | Drug | Quadratus Lumborum Block type II, Transversus Abdominalis Plane Block |
| UltraplexA non-stimulating echogenic single-shot needle designed for regional analgesia under ultrasound guidance. | Device | Quadratus Lumborum Block type II, Transversus Abdominalis Plane Block |
Primary outcome
Total postoperative fentanyl usage
Time frame: 24 hours
Total cumulative fentanyl dose used in the first 24 hours after surgery
4 secondary outcomes
Time to first analgesic (TTFA)
Time frame: 24 hours
Postoperative pain severity in Numerical Rating Scale (NRS) in the first 24 hours after surgery
Time frame: 24 hours
Nausea or vomiting
Time frame: 24 hours
Sedation Level
Time frame: 24 hours
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 22 May 2018.
- Derived from this study: PubMed 32175985Kolacz M, Mieszkowski M, Janiak M, Zagorski K, Byszewska B, Weryk-Dysko M, Onichimowski D, Trzebicki J. Transversus abdominis plane block versus quadratus lumborum block type 2 for analgesia in renal transplantation: A randomised trial. Eur J Anaesthesiol. 2020 Sep;37(9):773-789. doi: 10.1097/EJA.0000000000001193.
- 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.
Marcin Kolacz, MD,PhD study director
Medical University of Warsaw
Marcin Mieszkowski, MD principal investigator
Faculty of Medical Sciences, University of Warmia and Mazury in Olsztyn, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Quadratus Lumborum Block type II, Transversus Abdominalis Plane Block and Bupivacaine in people with Postoperative Pain, run by Medical University of Warsaw at 1 site in Poland.
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 2 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 22 May 2018. 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 Poland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 postoperative fentanyl usage (time frame: 24 hours). 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 NCT02783586, 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 22 May 2018.