Comparison of Pericapsular Nerve Group (PENG) Block With a Combined Femoral and Sciatic Nerve Block for Postoperative Analgesia in Secondary Total Hip Arthroplasty; (REVPET)
- Conditions
- Hip Arthroplasty ReplacementPost Operative AnalgesiaPost Operative Pain, Acute
- Interventions
- Drug: Pericapsular nerve group (PENG) block with 0.75% ropivacaine guided by ultrasoundDrug: Femoral nerve block with 0.375% ropivacaine guided by ultrasound
- Registration Number
- NCT07109388
- Lead Sponsor
- Centre Hospitalier Universitaire Vaudois
- Brief Summary
The aim of this clinical trial is to compare the analgesic effect of a pericapsular nerve group (PENG) block with a combined femoral and sciatic nerve block for postoperative analgesia in patients scheduled for secondary total hip arthroplasty. The primary objective of this study is to compare postoperative pain management between the PENG block and the combined block (femoral and sciatic) by measuring postoperative morphine consumption in each of the two groups.
Participants will be randomized into two groups. Patients assigned to the PENG group will receive a PENG block with ropivacaine, followed by a sham (sciatic) block, and spinal anesthesia with isobaric bupivacaine. Patients assigned to the combined block group will receive femoral and sciatic nerve blocks with ropivacaine, followed by spinal anesthesia with isobaric bupivacaine.
- Detailed Description
This is a single-center, prospective, superiority, randomized, double-blind, parallel-group study.
Patients will be randomized into two groups of 25 patients each, for a total enrollment plan of 50 patients. After written informed consent, patients will be allocated to one of the two groups according to a computer-generated randomization list.
The nerve blocks will be performed using ultrasound guidance.
During the surgery, 0.15 mg/kg of dexamethasone IV, 1 g paracetamol IV, 30 mg ketorolac IV, and 40 mg/kg magnesium IV will be given for postoperative analgesia.
In the PACU, pain management will be provided as needed with 2 mg of IV morphine at ten-minute intervals for pain scores \>4. Once spinal motor block has resolved, the patients will be transferred to the surgical ward with a morphine patient-controlled analgesia (PCA) pump. The pump parameters will allow 2 mg boluses of morphine with a 10-minute lockout and a maximum dose of 40 mg in 4 hours.
Basal analgesia will be provided with paracetamol (1 g/6 h) and ibuprofen (400 mg/8 h). Ondansetron (4 mg IV) will be administered in case of nausea or vomiting.
A research assistant will conduct postoperative visits at 2 hours, 1 day, and 2 days postoperatively to record research data. Functional testing will be done on days 1 and 2 by physiotherapy personnel.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
- Male and female patients
- ASA (American Society of Anaesthesiologists) I-III
- 18 years of age or older
- Patients scheduled for elective secundary hip arthroplasty
- Able to give written conformed consent autonomously
- Refusal or inability to give consent
- Allergy to any of: ropivacaine, paracetamol, ibuprofen, ketorolac, morphine, ondansetron or dexamethasone
- Bleeding diathesis
- Neurological deficit of the operative side
- Existing preoperative opioid use
- Renal insufficiency (GFR<30ml/min according to the Cockroft-Gault formula)
- Hepatic insufficiency
- Morbid Obésity III
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PENG group Pericapsular nerve group (PENG) block with 0.75% ropivacaine guided by ultrasound Pericapsular nerve group block Combined nerve block Femoral nerve block with 0.375% ropivacaine guided by ultrasound Combined femoral and sciatic nerve block
- Primary Outcome Measures
Name Time Method Cumulative postoperative morphine consumption at day 1 Time Frame: 24 hours postoperatively Description: total consumption in mg
- Secondary Outcome Measures
Name Time Method Morphine consumption in the recovery room from admission till discharge from the recovery room, up to 2 hours consumption in mg
PCA administered morphine consumption at day 2 at day 2 postoperatively consumption in mg administered by PCA
Rest and dynamic pain scores At 2 hours, day 1 and day 2 postoperatively Visual Analogue Scale(VAS), 0-10
Incidence of postoperative nausea and vomiting at 2 hours, day 1 and day 2 postoperatively Presence of nausea or vomiting in the postoperative period
Incidence of pruritus at 2 hours, day 1 and day 2 postoperatively Presence of pruritus in the postoperative period
Incidence of urinary retention requiring bladder catheterisation from surgery till day 2 postoperatively Urinary retention requiring catheterisation
Duration of analgesia from the time the study procedure is performed up to 36 hours after surgery Time between study procedure and the first dose of iv morphine
Operated limb quadriceps strength At day 1 and day 2 postoperatively Medical Research Council Manual Muscle Testing scale, 0-5
Walking test At day 1 and 2 postoperatively Maximum distance travelled (meters)