Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This randomized, double-blinded, placebo-controlled trial seeks to evaluate the efficacy of the pericapsular nerve group block on postoperative rehabilitation.
The pericapsular nerve group, or PENG block, has been recently described and shows promise in providing analgesia to the hip joint. However, the effect of this block on postoperative rehabilitation is uncertain. This study compares a preoperative PENG block to a placebo before total hip arthroplasty under spinal anesthesia. The primary outcome measure is verticalization, walking distance, ability to go out of bed, active lifting of the limb, range of motion in the hip joint, bending range of motion, and abduction range of motion. The secondary measure is postoperative pain assessment during rehabilitation.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PENG with 20mL 0,5% Ropivacaine | Experimental | Patients will receive a preoperative ultrasound-guided pericapsular nerve group block with 20 mL of 0.5% ropivacaine. Using appropriate sterile precautions and procedural sedation with up to 2 mg IV midazolam, an ultrasound (Mindrey TE9) equipped with either a linear 15-6 megahertz (MHz) or a curvilinear 5-2 MHz transducer (habitus-dependent) used to identify the anterior inferior iliac spine, iliopubic eminence, and psoas muscle. After spinal anesthesia, a 22g 80 mm echogenic block needle (Stimuplex Ultra 360) is advanced lateral to medial, in the plane with the ultrasound beam, beneath the psoas tendon to the iliopubic eminence. 20 mL 0.5% ropivacaine is injected beneath the psoas tendon and above the iliopubic eminence in 5 mL increments with a periodic aspiration to prevent intravascular injection. The needle is withdrawn, and the needle entry site is wiped clean. |
|
| PENG block with 20mL 0,9% normal saline | Experimental | Patients will receive a preoperative ultrasound-guided pericapsular nerve group block with 20 mL of 0.9% normal saline. Using appropriate sterile precautions and procedural sedation with up to 2 mg IV midazolam, an ultrasound (Mindrey TE9) equipped with either a linear 15-6 megahertz (MHz) or a curvilinear 5-2 MHz transducer (habitus-dependent) used to identify the anterior inferior iliac spine, iliopubic eminence, and psoas muscle. After spinal anesthesia, a 22g 80 mm echogenic block needle (Stimuplex Ultra 360) is advanced lateral to medial, in the plane with the ultrasound beam, beneath the psoas tendon to the iliopubic eminence. 20 mL 0.9% normal saline is injected beneath the psoas tendon and above the iliopubic eminence in 5 mL increments with a periodic aspiration to prevent intravascular injection. The needle is withdrawn, and the needle entry site is wiped clean. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine 0.5% Injectable Solution | Drug | 20 mL 0.5% ropivacaine will be injected for the PENG block |
|
| Measure | Description | Time Frame |
|---|---|---|
| postoperative Numeric Pain Rating Scale in motion | Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable") | Day 2 |
| postoperative Numeric Pain Rating Scale in motion | Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable") | Day 3 |
| postoperative Numeric Pain Rating Scale in motion | Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable") | Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| total opioid consumption | milligrams of intravenous morphine equivalents | 96 hours postoperatively |
| Time to first opioid | Hours to first administration of an intravenous opioid drug |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Małgorzata Domagalska, PhD | Department of Palliative Medicine, University of Medical Sciences, Poznań, Poland | Principal Investigator |
| Zbigniew Żaba, PhD | Department of Emergency Medicine Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Poznan Univesity of Medical Sciences | Poznan | Wielkopolska | 61-701 | Poland |
The data presented in this study are available on request from the corresponding author.
December 2024
The data presented in this study are available on request from the corresponding author.
Not provided
Not provided
| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
Not provided
Not provided
randomized, double-blind, placebo-controlled
Not provided
Not provided
Not provided
| 0,9% normal saline | Drug | 20 mL 0.9% normal saline will be injected for the PENG block |
|
|
| 96 hours postoperatively |
| postoperative Numeric Pain Rating Scale et rest | representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable") | Day 1 |
| postoperative Numeric Pain Rating Scale et rest | representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable") | Day 2 |
| postoperative Numeric Pain Rating Scale et rest | representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable") | Day 3 |
| postoperative Numeric Pain Rating Scale et rest | representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable") | Day 4 |
| Functional assessment: getting out of bed without help | Binary assessment of motor function evaluated at the first day after surgical procedure | First day after surgery |
| Functional assessment: active elevation of the operated limb | Binary assessment of motor function evaluated at the first day after surgical procedure | First day after surgery |
| Functional assessment: independent verticalization- by the balcony | Binary assessment of motor function evaluated at the first day after surgical procedure | First day after surgery |
| Functional assessment: walking by the balcony | Binary assessment of motor function evaluated at the first day after surgical procedure | First day after surgery |
| D012216 |
| Rheumatic Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |