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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PENG group | Experimental | Pericapsular nerve group block |
|
| Combined nerve block | Active Comparator | Combined femoral, sciatic, lateral femoral cutaneous nerve block |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pericapsular nerve group (PENG) block with 0.75% ropivacaine guided by ultrasound | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative postoperative morphine consumption at day 1 | Description: total consumption in mg | Time Frame: 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Morphine consumption in the recovery room | consumption in mg | from admission till discharge from the recovery room, up to 2 hours |
| PCA administered morphine consumption at day 2 | consumption in mg administered by PCA |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eric Albrecht, Prof | Contact | +41795566341 | eric.albrecht@chuv.ch | |
| Melissa Wüst | Contact | +41795569991 | melissa.wust@chuv.ch |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38584259 | Background | She C, Liu H. The efficacy of pericapsular nerve group block for reducing pain and opioid consumption after total hip arthroplasty: a systematic review and meta-analysis. J Orthop Surg Res. 2024 Apr 8;19(1):229. doi: 10.1186/s13018-024-04707-x. | |
| 27514736 | Background | Newman JT, Briggs KK, McNamara SC, Philippon MJ. Outcomes After Revision Hip Arthroscopic Surgery in Adolescent Patients Compared With a Matched Cohort Undergoing Primary Arthroscopic Surgery. Am J Sports Med. 2016 Dec;44(12):3063-3069. doi: 10.1177/0363546516659656. Epub 2016 Aug 11. |
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This is a single-center, prospective, superiority, randomized, double-blind, parallel-group study.
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|
| Femoral, sciatic and lateral femoral cutaneous nerve block with 0.375% ropivacaine | Drug | 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. |
|
| at day 2 postoperatively |
| Rest and dynamic pain scores | Visual Analogue Scale(VAS), 0-10 | At 2 hours, day 1 and day 2 postoperatively |
| Incidence of postoperative nausea and vomiting | Presence of nausea or vomiting in the postoperative period | at 2 hours, day 1 and day 2 postoperatively |
| Incidence of pruritus | Presence of pruritus in the postoperative period | at 2 hours, day 1 and day 2 postoperatively |
| Incidence of urinary retention requiring bladder catheterisation | Urinary retention requiring catheterisation | from surgery till day 2 postoperatively |
| Duration of analgesia | Time between study procedure and the first dose of iv morphine | from the time the study procedure is performed up to 36 hours after surgery |
| Operated limb quadriceps strength | Medical Research Council Manual Muscle Testing scale, 0-5 | At day 1 and day 2 postoperatively |
| Walking test | Maximum distance travelled (meters) | At day 1 and 2 postoperatively |
| 26507527 | Background | Bohl DD, Samuel AM, Basques BA, Della Valle CJ, Levine BR, Grauer JN. How Much Do Adverse Event Rates Differ Between Primary and Revision Total Joint Arthroplasty? J Arthroplasty. 2016 Mar;31(3):596-602. doi: 10.1016/j.arth.2015.09.033. Epub 2015 Sep 28. |
| 12533568 | Background | Mahomed NN, Barrett JA, Katz JN, Phillips CB, Losina E, Lew RA, Guadagnoli E, Harris WH, Poss R, Baron JA. Rates and outcomes of primary and revision total hip replacement in the United States medicare population. J Bone Joint Surg Am. 2003 Jan;85(1):27-32. doi: 10.2106/00004623-200301000-00005. |
| 17403800 | Background | Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222. |
| 32151524 | Background | Schwartz AM, Farley KX, Guild GN, Bradbury TL Jr. Projections and Epidemiology of Revision Hip and Knee Arthroplasty in the United States to 2030. J Arthroplasty. 2020 Jun;35(6S):S79-S85. doi: 10.1016/j.arth.2020.02.030. Epub 2020 Feb 19. |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D003766 | Dental Occlusion |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D003813 | Dentistry |
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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