PENG Block Combined to Wound Infiltration for Hip Replacement

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04306133
• Other study ID #: 29/20 PAR ComEt CBM
• Status: Completed
• Phase: N/A
• Start date: March 9, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2021
• Source: Campus Bio-Medico University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Acute Pain
• Analgesia
• Hip Arthropathy
• Joint Diseases
• Pain
• Postoperative Complications
• Postoperative Pain

Intervention

Procedure:
• PENG block
After performing spinal anesthesia, PENG block with 20 mL of 0.375 % Ropivacaine will be executed as described by Giron-Arongo et al with a low frequency curvilinear probe. A 22G 80 mm needle (Stimuplex Ultra 360, Braun ) will be used.
• Wound Infiltration
At the end of operation, the surgeon will perform wound infiltration with 20 mL of 0.375 % Ropivacaine.

Locations

Country	Name	City	State
Italy	Università Campus Biomedico	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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

Outcome

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