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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001956-21 | EudraCT Number |
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This study examine the effect of Pericapsular Nerve Group (PENG) Block on analgesia after elective hip arthroplasty. Half of participants will receive a PENG Block with local anesthetic, while the other half will receive a PENG Block with a placebo.
Optimized analgesia is crucial for early mobilization after hip arthroplasty. Regional anesthesia, like fascia iliaca block or femoral nerve block, have limited indication because of motor blockade whereas local infiltrations analgesia have shown conflicting analgesic efficacy results in hip arthroplasty.
Pericapsular nerve group (PENG) block is a new regional anesthesia technique targeting specifically sensory nerve branches of the hip articulation. It has been originally described in hip fracture patients.
The aim of this study is to evaluate the efficacy of PENG block on analgesia after elective hip arthroplasty.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PENG group | Experimental | PENG block with 20 ml of a mixture of 1% Lidocaine with 0,5% Ropivacaine and 1/400.000 Epinephrine |
|
| Placebo group | Placebo Comparator | PENG block with 20 ml of 0,9% saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PENG Block with local anesthetic | Procedure | After induction of general anesthesia, PENG block with 20 ml of a mixture of 1% Lidocaine with 0,5% Ropivacaine and 1/400.000 Epinephrine will be performed as described by Giron-Arongo et al with a high frequency linear probe. A 22G 80 mm needle (SonoPlex, Pajunk ) will be used. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score on first Mobilization | A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain on first mobilization at day 0 after surgery | Postoperative time until midnight day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Pain Score in Post-Anaesthesia Care Unit | Maximum Pain score evaluated in Post Anesthesia Care Unit by a a visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) | Through postoperative time during Post Anesthesia Care Unit stay at day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction after 24h | Patient satisfaction for the first 24h after surgery recorded with a scale from 0 (unsatisfied) to 10 (extremely satisfied). | 24 hours after surgery |
| Length of hospital stay |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicolas Van Rompaey, MD | Contact | +3264276111 | nvrompae@chu-tivoli.be |
| Name | Affiliation | Role |
|---|---|---|
| Nicolas Van Rompaey, MD | Centre Hospitalier Universitaire de Tivoli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Tivoli | Recruiting | La Louvière | 7100 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30063657 | Background | Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000779 | Anesthetics, Local |
| ID | Term |
|---|---|
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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Injected solutions will be prepared by an anesthetist not involved in the study protocol.
|
| PENG Block with 0,9% saline | Procedure | After induction of general anesthesia, PENG block with 20 ml of 0,9% saline will be performed as described by Giron-Arongo et al with a high frequency linear probe. A 22G 80 mm needle (SonoPlex, Pajunk ) will be used. |
|
| Morphine Consumption at Day 0 |
Total of Piritramid, Oxycodone and Oxycodone Extended Released expressed as equivalent of morphine at day 0 |
| Postoperative time until midnight day 0 |
| Piritramid Consumption | Total of Piritramid use from the end of surgery until Post Anesthesia Care Unit discharge to the ward | Through the end of surgery until Post Anesthesia Care Unit discharge to the ward at day 0 |
| Morphine Consumption at Day 1 | Total of Oxycodone and Oxycodone Extended Released expressed as equivalent of morphine at day 1 | Postoperative time during Post Anesthesia Care Unit stay at day 0 |
| Morphine Consumption at Day 2 | Total of Oxycodone and Oxycodone Extended Released expressed as equivalent of morphine at day 2 | Postoperative time until midnight day 2 |
| Pain Score at Rest 2h Postop | A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain at rest 2h after surgery | 2 hours after surgery |
| Pain Score on mobilization 2h Postop | A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization 2h after surgery | 2 hours after surgery |
| Pain Score at Rest 4h Postop | A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain at rest 4h after surgery | 4 hours after surgery |
| Pain Score on mobilization 4h Postop | A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization 4h after surgery | 4 hours after surgery |
| Pain Score at Rest 6h Postop | A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain at rest 6h after surgery | 6 hours after surgery |
| Pain Score on mobilization 6h Postop | A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization 6h after surgery | 6 hours after surgery |
| Pain Score at Rest Day 1 AM | A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain at rest in the morning of day 1 | Day 1 in the morning after surgery |
| Pain Score on mobilization Day 1 AM | A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization in the morning of day 1 | Day 1 in the morning after surgery |
| Pain Score at Rest Day 1 PM | A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain at rest in the afternoon of day 1 | Day 1 in the afternoon after surgery |
| Pain Score on mobilization Day 1 PM | A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization in the afternoon of day 1 | Day 1 in the afternoon after surgery |
| Pain Score at Rest Day 2 AM | A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain at rest in the morning of day 2 | Day 2 in the morning after surgery |
| Pain Score on mobilization Day 2 AM | A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization in the morning of day 2 | Day 2 in the morning after surgery |
| Pain Score at Rest Day 2 PM | A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain at rest in the afternoon of day 2 | Day 2 in the afternoon after surgery |
| Pain Score on mobilization Day 2 PM | A visual analog pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain on mobilization in the afternoon of day 2 | Day 2 in the afternoon after surgery |
| First Mobilization Success | Success rate of patients mobilized the day of surgery | Postoperative time until midnight day 0 |
| Mean remifentanil Infusion Rate | Total infused remifentanil dose per kg body weight per minute of total operative time | Intraoperatively |
| Quadriceps weakness | Evaluation of quadriceps motricity by Neal test which consist in supporting the knee under the popliteal fossa and asking the patient to extend the knee against resistance. | Through postoperative time during Post Anesthesia Care Unit stay at day 0 |
Calculated as the number of days between the hospital admission and discharge dates.
| During hospital stay, up to 1 week |
| PACU stay | Time from the arrival in Post Anesthesia Care Unit until discharge to the ward | Postoperative time during Post Anesthesia Care Unit stay at day 0 |
| Postoperative Nausea and Vomiting | The incidence and severity of postoperative nausea (none=0, mild=1, moderate=2, severe=3), episodes of vomiting, and need for rescue antiemetics was also documented. | PACU, at 2, 6, 24, and 48 hours |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |