Pain, Lithiasis
Conditions
Brief summary
This study is designed to compare analgesic effect of both the ultrasound (US)-guided QLB and ESPB blocks during ESWL and their effect on stone fragmentation.
Detailed description
Urinary tract calculi, one of the most common benign urological diseases, is seen in 12% of patients and has a recurrence rate of approximately 50%. Management of renal calculi is known to be affected by many factors, specially tolerance of pain during ESWL and how it is controlled. Pain experienced during ESWL is thought to occur when shock waves from the lithotripter reach superficial structures such as skin and also deeper structures such as the ribs, nerves and the kidney capsule. There are three main factors that contribute to the propagation of pain at these structures: shock wave (SW) pressure, distribution, and focal area size . Conventionally, pain during ESWL is managed by basic analgesics such as NSAIDs, which can also aid in stone clearance. Other methods of analgesia also have been studied and tested. Quadratus lumborum block (QLB) was first described by Blanco in 2007, it blocks T7-L1 nerve fibres in most of the cases. Studies have reported its use in the management of postoperative pain after hip surgeries. Erector Spinae Plane Block (ESPB) is another such block, that is increasingly tried for the management of postoperative pain for breast surgery, thoracic surgery, and also upper abdominal surgeries. ESPB when given at the lumbar region gives blockade from C7-T2 to L2-L3.
Interventions
PROCEDUREQuadratus lumborum block type III
Patients will be placed in lateral decubitus position with the side of the target stone facing up. After sterilization and draping of the skin, using US probe the block will be applied targeting the fascial plane between the quadratus lumborum and psoas major muscles (anterior aspect of the quadratus lumborum). After 20 min, sensory blockade will be evaluated with pinprick test, if loss of sensation is achieved at the T7-L1 dermatome site, the block is considered successful and patients will be transferred to ESWL Room.
PROCEDUREErector spinae plane block
Patients will be placed in the lateral decubitus position according to the selected site. After sterilization and draping of the skin, using US probe, the block will be applied in the plane deep to the erector spinae muscles and superficial to the transverse process. After 20 min, sensory blockade will be assessed with pinprick test, if loss of sensation is achieved at the T7-L1 dermatome site, the block is considered successful and patients is transferred to ESWL Room.
Sponsors
South Valley University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
controlled, randomized, assessor blinded clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Informed written consent obtained * Age 18-60 * Both sex * American Society of Anesthesiologists(ASA) physical status: I, II * Stone pelvis less than 2.5 cm * Indicated for ESWL
Exclusion criteria
* refusal of participation by parents or caregivers. * ASA physical status: \> II * Stone pelvis \>2.5 cm * Chronic pain * On chronic NSAID or opioid * Substance addict * Known local anesthetic drug sensitivity. * Preexisting infection at block site * Coagulopathy or anticoagulation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic Effect: cumulative opioid dose | At 30 minutes | Comparing analgesic Effect of both QLB and ESPB by calculating the total opioid consumption over the total duration of session (approximately 30 minutes) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stone fragmentation: shockwave energy | at 30 minutes | the level of energy will increase gradually, with shock waves between 3,500 and 5,000 in the 2-4 kilovolt (kV) energy range. Fluoroscopy will be used to check the stone and confirm fragmentation. Then maximum and mean energy of shock that is used will be calculated at the end of session approximately 30 min |
| Block failure rate | Immediately After 20 minutes of intervention | the block will be considered a failed block if the sensory block level of T7-L1 is not achieved after assessment with pinprick test. |
| The regional block time | procedure (At the end of intervention) | defined as the time taken from the start of the ultrasound scan to the completion of the local anesthetic injection. |
| Stone fragmentation: clearance rate | one week after ESWL session | Determining if stone fragmentation considered satisfactory or not, by Follow up kidney, ureter and bladder x-ray (KUB) and Ultrasound. |
| Adverse effects | immediately after 20 minutes of intervention | The incidence of adverse effects local (anesthetic toxic reactions, bleeding, or hematoma at the puncture position; failure of block). |
| Patient satisfaction | At 30 minutes | patient satisfaction will be recorded after the procedure using a five-point scale, where 1 is unsatisfied and 5 completely satisfied. At the end of session approximately 30 minutes |
| Feasibility of visualisation | procedure (At the end of intervention) | The ultrasound images will be evaluated with a 4-point method(10) : 0 points, unable to display; 1 point, the anatomical structure and injection target position are not clear, and the puncture needle is partially developed; 2 points, the anatomical structure, and injection target position are clear, but the puncture needle tip is poorly developed, and local anesthetic diffusion is limited; 3 points, typical anatomical structure, and injection target position, the puncture needle tip can be accurately identified, and local anesthetic diffusion is complete. Images with ≥2 points meant that local anesthetics could be injected. |
Countries
Egypt
Outcome results
None listed