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Erector spinae plane block for perioperative analgesia after percutaneous nephrolithotomy

Erector spinae plane block for perioperative analgesia after percutaneous nephrolithotomy

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000044123
Enrollment
75
Registered
2019-01-14
Start date
2019-01-22
Completion date
2020-04-28
Last updated
2020-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Erector spinae plane block (ESPB) was recently introduced as an alternative for postoperative analgesia in many surgeries including thoracotomies, cholecystectomies or mastectomies. It lowers the opioid consumption and thus decrease the rate of their side effects. In ESPB, local anesthetic is reported to be administered into the interfascial plane between the transverse process of the vertebra and the erector spinae muscles, spreading to multiple paravertebral spaces. Case reports have reported that ESPB effects both the ventral and dorsal rami and leading to blockage of both visceral and somatic pain. There are no clinical trials regarding ESPB in PCNL. The aim of our study was to test the efficacy and safety of ESPB after percutaneous nephrolithotripsy.

Interventions

Anesthesia: Standard monitoring procedures include pulse oximetry, electrocardiography, and noninvasive arterial pressure performed prior to anesthesia. Baseline heart rates, systolic and diastolic blood pressures and mean arterial pressures are recorded before anesthesia. All patients will be given antibiotic prophylaxis, according to the hospital's protocol. Induction will be performed using bolus of propofol 2mg/kg intravenously , bolus of fentanyl 100 µg intravenously and bolus of rocuronium

Anesthesia: Standard monitoring procedures include pulse oximetry, electrocardiography, and noninvasive arterial pressure performed prior to anesthesia. Baseline heart rates, systolic and diastolic blood pressures and mean arterial pressures are recorded before anesthesia. All patients will be given antibiotic prophylaxis, according to the hospital's protocol. Induction will be performed using bolus of propofol 2mg/kg intravenously , bolus of fentanyl 100 µg intravenously and bolus of rocuronium bromide 0,6 -0,8 mg/kg intravenously 0,8 -1,2 MAC sevoflurane via endotracheal tube. and 0,08 µg/kg/min remifentanil intravenously infusion will be used for anesthesia maintenance. Remifentanil dosage will be adjusted according to hemodynamic parameters, up to 2 µg/kg/min. After completion of surgery, patients are extubated when adequate muscle strength is established, and they are transferred to the recovery room. Local anesthesia will not be applied to wounds. Each patient will receive patient controlled analgesia (PCA) pump (nalbuphine) and 1 g of paracetamolum intravenously every 6 hours as standard postoperative pain treatment. If VAS scale exceeds 4 in any measure, in addition, dexketoprofen 50 mg intravenously every 8 hours will be given. All medications exept nalbuphine are administered by anesthesiologist nurse. ESPB: All blocks will be performed under sedoanalgesia and before general anesthesia induction. Following routine monitoring and premedication the patients will be placed in the sitting position. ESPB is performed under ultrasonographic guidance. The linear ultrasound transducer is placed in a longitudinal parasagittal orientation 3 cm lateral to the T7 spinous process. The erector spinae muscles are identified superficial to the tip of the T7 transverse process. The patient's skin is anesthetized with 3mL of 2% lidocaine subcutaneously. The tip of the 22G needle is placed into the fascial plane on the deep (anterior) aspect of erector spinae muscle. The location of the needle tip is confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging of the transverse process on ultrasonographic imaging. A total of 20mL of 0.5% bupivacaine will be injected to this site. In addition dexamethasone 0,1 mg/kg intravenously is administered. This block is performed by anaethesiologist. PCNL: All patients qualified for PCNL had contrast-enhanced computed tomography performed before surgery. Briefly, we operate patients in prone position with utilization of Amplatz dilators and sheaths. Patients are operated in general anesthesia. Perioperatively 1,5 g cephalosporin 2nd (Cefuroxime) generation intravenously is used as antibiotic prophylaxis . Puncture and tract formation is done by urologist under fluoroscopic guidance. We use 26 Fr nephroscope with ultrasound as well as pneumatic lithotripter to disintegrate the stone. At the end of PCNL re-entry Malecot (16Fr) nephrostomy is inserted and maintained for 4 days. PCNL is performed by urologist. The procedure lasts for approximately 90-120 minutes. Intervention: Patients will be divided into two groups. First group (n=35) will comprise patients where only PCA + paracetamolum is used for postoperative analgesia while patients in the second group (n=35) will receive ESPB and PCA + paracetamolum. Rescue analgesia with dexketoprofen 50 mg every 8 hours will be administered when VAS > 4 in any measurement in any group.

Sponsors

Piotr Bryniarski
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

a. Patients who gave informed consent for participation in the study b. Age 18-70 years c. ASA I-III d. Patients with BMI < 35 e. Patients with kidney stone over 2 cm in diameter or patients with kidney stones 1 - 2 cm who wished to have PCNL instead of retrograde intrarenal surgery or shockwave lithotripsy (SWL) or patients with kidney stones 1 - 2 cm with contraindications for SWL f. Single access PCNL

Exclusion criteria

a. Residual stones after surgery and need for a second look b. Bleeding diathesis c. Solitary kidney d. Dermal infection in injection site e. Contrast and drug allergy f. Routine antidepressants, corticosteroids, pain medications, anticonvulsants use g. Massive bleeding during operation which requires clamping the nephrostomy or open surgery h. Need to apply other pain medications or neuroleptics postoperatively

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026