Clinical trial NCT02783586: TAPB vs QLBII for Kidney Transplantation Procedure
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2016-05-26
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Kidney transplantation procedure with anatomical urinary outlet
2. Written informed consent

Exclusion Criteria:

1. Patients' refusal
2. Known allergies to study medication
3. Inability to comprehend or participate in pain scoring scale
4. Inability to use intravenous patient controlled analgesia system
5. Anatomic, posttraumatic and postoperative deformations could possibly affect the spread of local anesthetic in transversus abdominalis plane or quadratus lumborum muscle plane.
6. Transversus abdominalis plane or quadratus lumborum muscle plane not seen in ultrasound examination.

Primary outcomes:
measure: Total postoperative fentanyl usage
timeFrame: 24 hours
Secondary outcomes:
measure: Time to first analgesic (TTFA)
timeFrame: 24 hours
measure: Postoperative pain severity in Numerical Rating Scale (NRS) in the first 24 hours after surgery
timeFrame: 24 hours
measure: Nausea or vomiting
timeFrame: 24 hours
measure: Sedation Level
timeFrame: 24 hours
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: I Department of Anaesthesiology and Intensive Care, Medical University of Warsaw
Study officials:
affiliation: Medical University of Warsaw
name: Marcin Kolacz, MD,PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Medical Sciences, University of Warmia and Mazury in Olsztyn, Poland
name: Marcin Mieszkowski, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.