Postoperative Pain
Conditions
Keywords
Elective Hip Surgery, PENG Block
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREPENG Block with local anesthetic
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.
PROCEDUREPENG Block with 0,9% saline
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.
Sponsors
Centre Hospitalier Universitaire de Tivoli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Injected solutions will be prepared by an anesthetist not involved in the study protocol.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Elective total hip arthroplasty * General anesthesia * Enhanced Recovery Program
Exclusion criteria
* American Society of Anesthesiologists (ASA) Score \> 2 * Drug allergy * Significant psychiatric disturbances * Preoperative opioid use * Contraindication to acetaminophen, celecoxib, methylprednisolone or tranexamic acid * Body Mass Index \> 40 kg/m²
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score on first Mobilization | Postoperative time until midnight day 0 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score at Rest 6h Postop | 6 hours after surgery | 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 |
| Pain Score on mobilization Day 2 PM | Day 2 in the afternoon after surgery | 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 |
| First Mobilization Success | Postoperative time until midnight day 0 | Success rate of patients mobilized the day of surgery |
| Mean remifentanil Infusion Rate | Intraoperatively | Total infused remifentanil dose per kg body weight per minute of total operative time |
| Quadriceps weakness | Through postoperative time during Post Anesthesia Care Unit stay at day 0 | 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. |
| Maximum Pain Score in Post-Anaesthesia Care Unit | Through postoperative time during Post Anesthesia Care Unit stay at day 0 | 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 \[100-mm scale\]) |
| Morphine Consumption at Day 0 | Postoperative time until midnight day 0 | Total of Piritramid, Oxycodone and Oxycodone Extended Released expressed as equivalent of morphine at day 0 |
| Piritramid Consumption | Through the end of surgery until Post Anesthesia Care Unit discharge to the ward at day 0 | Total of Piritramid use from the end of surgery until Post Anesthesia Care Unit discharge to the ward |
| Morphine Consumption at Day 1 | Postoperative time during Post Anesthesia Care Unit stay at day 0 | Total of Oxycodone and Oxycodone Extended Released expressed as equivalent of morphine at day 1 |
| Morphine Consumption at Day 2 | Postoperative time until midnight day 2 | Total of Oxycodone and Oxycodone Extended Released expressed as equivalent of morphine at day 2 |
| Pain Score at Rest 2h Postop | 2 hours after surgery | 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 |
| Pain Score on mobilization 2h Postop | 2 hours after surgery | 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 |
| Pain Score at Rest 4h Postop | 4 hours after surgery | 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 |
| Pain Score on mobilization 4h Postop | 4 hours after surgery | 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 |
| Pain Score on mobilization 6h Postop | 6 hours after surgery | 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 |
| Pain Score at Rest Day 1 AM | Day 1 in the morning after surgery | 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 |
| Pain Score on mobilization Day 1 AM | Day 1 in the morning after surgery | 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 |
| Pain Score at Rest Day 1 PM | Day 1 in the afternoon after surgery | 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 |
| Pain Score on mobilization Day 1 PM | Day 1 in the afternoon after surgery | 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 |
| Pain Score at Rest Day 2 AM | Day 2 in the morning after surgery | 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 |
| Pain Score on mobilization Day 2 AM | Day 2 in the morning after surgery | 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 |
| Pain Score at Rest Day 2 PM | Day 2 in the afternoon after surgery | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| PACU stay | Postoperative time during Post Anesthesia Care Unit stay at day 0 | Time from the arrival in Post Anesthesia Care Unit until discharge to the ward |
| Postoperative Nausea and Vomiting | PACU, at 2, 6, 24, and 48 hours | 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. |
| Length of hospital stay | During hospital stay, up to 1 week | Calculated as the number of days between the hospital admission and discharge dates. |
| Patient satisfaction after 24h | 24 hours after surgery | Patient satisfaction for the first 24h after surgery recorded with a scale from 0 (unsatisfied) to 10 (extremely satisfied). |
Countries
Belgium
Contacts
Primary ContactNicolas Van Rompaey, MD
Outcome results
None listed