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CompletedNCT02783586

TAPB vs QLBII for Kidney Transplantation Procedure

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
104 (actual)
Sponsor
Medical University of Warsaw · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREQuadratus Lumborum Block type IILocal anaesthetic injection on the posterior border of the quadratus lumborum muscle
PROCEDURETransversus Abdominalis Plane BlockLocal anaesthetic injection between internal oblique and transversus abdominis muscle
DRUGBupivacaine20 ml of bupivacaine with adrenaline
DEVICEUltraplexA non-stimulating echogenic single-shot needle designed for regional analgesia under ultrasound guidance.

Timeline

Start date
2016-04-08
Primary completion
2017-05-29
Completion
2017-05-30
First posted
2016-05-26
Last updated
2018-05-22

Locations

1 site across 1 country: Poland

Source: ClinicalTrials.gov record NCT02783586. Inclusion in this directory is not an endorsement.