Postoperative Pain
Conditions
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.
Interventions
PROCEDUREQuadratus Lumborum Block type II
Local anaesthetic injection on the posterior border of the quadratus lumborum muscle
PROCEDURETransversus Abdominalis Plane Block
Local anaesthetic injection between internal oblique and transversus abdominis muscle
DRUGBupivacaine
20 ml of bupivacaine with adrenaline
DEVICEUltraplex
A non-stimulating echogenic single-shot needle designed for regional analgesia under ultrasound guidance.
Sponsors
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total postoperative fentanyl usage | 24 hours | Total cumulative fentanyl dose used in the first 24 hours after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to first analgesic (TTFA) | 24 hours | Time from the end of surgery to the first postoperative intravenous fentanyl administered from intravenous patient controlled analgesia ( IVPCA) device. |
| Postoperative pain severity in Numerical Rating Scale (NRS) in the first 24 hours after surgery | 24 hours | NRS range from 0 for no pain to 10 for worst pain imaginable. |
| Nausea or vomiting | 24 hours | 0- no nausea; 1- mild nausea; 2- moderate nausea; 3- severe nausea or vomiting |
| Sedation Level | 24 hours | 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. |
Countries
Poland
Outcome results
None listed