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PENG Block Combined to Wound Infiltration for Hip Replacement

Primary Purpose

Postoperative Pain, Analgesia, Hip Arthropathy

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

PENG block

Wound Infiltration

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring regional anesthesia, hip surgery, PENG

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Università Campus Biomedico

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PENG BLOCK AND WOUND INFILTRATION

WOUND INFILTRATION

Arm Description

Participants receiving PENG block combined to wound infiltration

Participants receiving wound infiltration alone

Outcomes

Primary Outcome Measures

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

Total opioids consumption

Total of Sublingual Sufentanil tablets released

Secondary Outcome Measures

Time to first opioid

Time (hours) from the end of surgery to the first opioid administration

Range of hip motion

Degrees of hip flexion

Time to ambulation

Time until the patient is able to stand up and walk with or without assistive devices

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

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.

Opioids side effects

The presence or absence of opioids side effects such as drowsiness, desaturation, nausea and vomiting

Full Information

NCT ID

NCT04306133

First Posted

March 8, 2020

Last Updated

April 5, 2021

Sponsor

Campus Bio-Medico University

1. Study Identification

Unique Protocol Identification Number

NCT04306133

Brief Title

PENG Block Combined to Wound Infiltration for Hip Replacement

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

March 9, 2020 (Actual)

Primary Completion Date

December 24, 2020 (Actual)

Study Completion Date

December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Campus Bio-Medico University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain, Analgesia, Hip Arthropathy, Acute Pain, Pain, Postoperative Complications

Keywords

regional anesthesia, hip surgery, PENG

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PENG BLOCK AND WOUND INFILTRATION

Arm Type

Experimental

Arm Description

Participants receiving PENG block combined to wound infiltration

Arm Title

WOUND INFILTRATION

Arm Type

Active Comparator

Arm Description

Participants receiving wound infiltration alone

Intervention Type

Procedure

Intervention Name(s)

PENG block

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Wound Infiltration

Intervention Description

At the end of operation, the surgeon will perform wound infiltration with 20 mL of 0.375 % Ropivacaine.

Primary Outcome Measure Information:

Title

Maximum Pain Score

Description

Time Frame

24 hours

Title

Total opioids consumption

Description

Total of Sublingual Sufentanil tablets released

Time Frame

48 hours

Secondary Outcome Measure Information:

Title

Time to first opioid

Description

Time (hours) from the end of surgery to the first opioid administration

Time Frame

48 hours

Title

Range of hip motion

Description

Degrees of hip flexion

Time Frame

24 hours

Title

Time to ambulation

Description

Time until the patient is able to stand up and walk with or without assistive devices

Time Frame

48 hours

Title

Quadriceps weakness

Description

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

Time Frame

48 hours

Title

Incidence of block complications

Description

Any complications or side effects of the blocks, such as local infection, intravascular injection of local anesthetics and immediate systemic toxicity.

Time Frame

48 hours

Title

Opioids side effects

Description

The presence or absence of opioids side effects such as drowsiness, desaturation, nausea and vomiting

Time Frame

48 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Giuseppe Pascarella, MD

Organizational Affiliation

University Hospital Campus Biomedico of Rome

Official's Role

Principal Investigator

Facility Information:

Facility Name

Università Campus Biomedico

City

Roma

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29140962

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.

Results Reference

background

PubMed Identifier

30063657

Citation

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.

Results Reference

result

PubMed Identifier

34196965

Citation

Pascarella G, Costa F, Del Buono R, Pulitano R, Strumia A, Piliego C, De Quattro E, Cataldo R, Agro FE, Carassiti M; collaborators. Impact of the pericapsular nerve group (PENG) block on postoperative analgesia and functional recovery following total hip arthroplasty: a randomised, observer-masked, controlled trial. Anaesthesia. 2021 Nov;76(11):1492-1498. doi: 10.1111/anae.15536. Epub 2021 Jul 1.

Results Reference

derived

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PENG Block Combined to Wound Infiltration for Hip Replacement

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