Pain Clinical Trial
Official title:
Pericapsular Nerve Group (PENG) Block Combined to Wound Infiltration vs. Wound Infiltration Alone for Postoperative Analgesia After Total Hip Replacement: a Prospective Controlled Trial
Verified date | April 2021 |
Source | Campus Bio-Medico University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study analyze the effect of Pericapsular Nerve Group (PENG) Block combined to wound infiltration for analgesia after elective hip replacement. Half of participants will receive a PENG Block combined with wound infiltration, while the other half will receive wound infiltration alone.
Status | Completed |
Enrollment | 60 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 24, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Elective hip replacement surgery - ASA physical status score < 4 Exclusion Criteria: - Contraindications to regional anesthesia - ASA physical status score = 4 - Patient's refusal or inability to sing the informed consent - Pre-operatively therapy with opioids - Allergies to any drug provided by the study protocol |
Country | Name | City | State |
---|---|---|---|
Italy | Università Campus Biomedico | Roma |
Lead Sponsor | Collaborator |
---|---|
Campus Bio-Medico University |
Italy,
Girón-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. — View Citation
Short AJ, Barnett JJG, Gofeld M, Baig E, Lam K, Agur AMR, Peng PWH. Anatomic Study of Innervation of the Anterior Hip Capsule: Implication for Image-Guided Intervention. Reg Anesth Pain Med. 2018 Feb;43(2):186-192. doi: 10.1097/AAP.0000000000000701. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum Pain Score | 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 during 48 h after surgery | 24 hours | |
Primary | Total opioids consumption | Total of Sublingual Sufentanil tablets released | 48 hours | |
Secondary | Time to first opioid | Time (hours) from the end of surgery to the first opioid administration | 48 hours | |
Secondary | Range of hip motion | Degrees of hip flexion | 24 hours | |
Secondary | Time to ambulation | Time until the patient is able to stand up and walk with or without assistive devices | 48 hours | |
Secondary | Quadriceps weakness | Presence of weakness of the quadriceps using a scale where 0= no effect; 1 = knee flexion possible but not hip flexion; 2 = absence of knee and hip flexion | 48 hours | |
Secondary | Incidence of block complications | Any complications or side effects of the blocks, such as local infection, intravascular injection of local anesthetics and immediate systemic toxicity. | 48 hours | |
Secondary | Opioids side effects | The presence or absence of opioids side effects such as drowsiness, desaturation, nausea and vomiting | 48 hours |
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