TAPB vs QLBII for Kidney Transplantation Procedure

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02783586
• Other study ID #: TAPB/QLB-WAW/OLS
• Status: Completed
• Phase: Phase 4
• Start date: April 8, 2016
• Est. completion date: May 30, 2017

Study information

• Verified date: May 2018
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: May 30, 2017
• Est. primary completion date: May 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Quadratus Lumborum Block type II
Local anaesthetic injection on the posterior border of the quadratus lumborum muscle
• Transversus Abdominalis Plane Block
Local anaesthetic injection between internal oblique and transversus abdominis muscle

Drug:
• Bupivacaine
20 ml of bupivacaine with adrenaline

Device:
• Ultraplex
A non-stimulating echogenic single-shot needle designed for regional analgesia under ultrasound guidance.

Locations

Country	Name	City	State
Poland	I Department of Anaesthesiology and Intensive Care, Medical University of Warsaw	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total postoperative fentanyl usage	Total cumulative fentanyl dose used in the first 24 hours after surgery	24 hours
Secondary	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.	24 hours
Secondary	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.	24 hours
Secondary	Nausea or vomiting	0- no nausea; 1- mild nausea; 2- moderate nausea; 3- severe nausea or vomiting	24 hours
Secondary	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.	24 hours