Hip Arthroplasty Replacement, Post Operative Analgesia, Post Operative Pain, Acute
Conditions
Keywords
nerve block, postoperative pain, hip arthroplasty replacement
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, sciatic, lateral femoral cutaneous 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, sciatic, lateral femoral cutaneous) 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, sciatic, lateral femoral cutaneous 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.
Interventions
DRUGPericapsular nerve group (PENG) block with 0.75% ropivacaine guided by ultrasound
Participants in the PENG group will first receive a sham sciatic injection; the needle will be inserted into the subcutaneous tissue and 3 ml of 0.9% NaCl will be injected. They will then receive a PENG nerve block in the supine position. A low-frequency (2-5 MHz) curvilinear ultrasound probe (BK Ultrasound) will be used to identify the anterior inferior iliac spine, the pubic eminence, and the psoas tendon with its fascial plane. A 22-gauge, 50 mm needle (SonoPlex® Pajunk) will be inserted into the fascial plane to inject 20 ml of 0.75% ropivacaine (Fresenius Kabi).
DRUGFemoral, sciatic and lateral femoral cutaneous nerve block with 0.375% ropivacaine
Participants in the combined group will first receive a sciatic nerve block performed with the patient in a semi-prone position, the lower limb flexed at 90° (hip and knee), elevated with a cushion placed between the legs. A straight line will be drawn between the greater trochanter and the ischial tuberosity. The sciatic nerve is located approximately at the midpoint of this line. Under ultrasound guidance, the ischial tuberosity will be identified medially, the greater trochanter laterally, the gluteus maximus muscle superficially beneath the adipose tissue, and the quadratus femoris muscle in depth. A 22-gauge, 50 mm needle will then be inserted into the fascial plane to inject 20 ml of 0.375% ropivacaine. The patient is then placed supine for femoral and lateral femoral cutaneous nerve blocks. 15 ml of local anaesthetics will be injected around the femoral nerve and 5 around the lateral femoral cutaneous nerve.
Sponsors
Centre Hospitalier Universitaire Vaudois
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
This is a single-center, prospective, superiority, randomized, double-blind, parallel-group study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative postoperative morphine consumption at day 1 | Time Frame: 24 hours postoperatively | Description: total consumption in mg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Morphine consumption in the recovery room | from admission till discharge from the recovery room, up to 2 hours | consumption in mg |
| 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) |
| Incidence of urinary retention requiring bladder catheterisation | from surgery till day 2 postoperatively | Urinary retention requiring catheterisation |
Contacts
Primary ContactEric Albrecht, Prof
Backup ContactMelissa Wüst
Outcome results
None listed