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Erector Spinae Block Versus PENG Block for Hip Replacement (PENGESP)

Primary Purpose

Pain, Postoperative

Status

Recruiting

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

ERECTOR SPINAE PLANE BLOCK

Peng block + lateral femoral cutaneous nerve block

spinal anesthesia

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

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

Inclusion Criteria: primary total hip replacement informed consent Exclusion Criteria: allergies to study drugs spinal anesthesia contraindicated kidney failure epilepsy, psychiatric disease, neurologic deficits revision surgery neuropathies in the lumbar area no informed consent pregnancy alcohol/opioid abuse emergency surgery/intensive care

Sites / Locations

Aast Papa Giovanni XxiiiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

ERECTOR SPINAE PLANE BLOCK

PERICAPSULARE NERVE GROUP AND LATERAL FEMORAL CUTANEOUS NERVE BLOCK

Arm Description

ultrasound guided block at L4

ultrasound guided block below the ileo-psoas muscle tendon, above the ilio-pectineous eminence and ultrasound guided block of lateral femoral cutaneous nerve

Outcomes

Primary Outcome Measures

morphine consumption

milligrams of morphine by patient controlled analgesia intravenously

Secondary Outcome Measures

postoperative pain

numeric rating scale - NRS 11 point scale from 0 = "no pain" to 10 = "worst imaginable pain"

neuropathic pain

DN4 questionnaire - 4 items questionnaire to investigate the occurrence of neuropathic component

postoperative complications

nausea, vomiting, vertigo, blurred vision, syncope, bleeding, falls

chronic postoperative pain

numeric rating scale 11 point scale from 0 = "no pain" to 10 = "worst imaginable pain"

Full Information

NCT ID

NCT05796804

First Posted

March 21, 2023

Last Updated

April 13, 2023

Sponsor

Papa Giovanni XXIII Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05796804

Brief Title

Erector Spinae Block Versus PENG Block for Hip Replacement

Acronym

PENGESP

Official Title

Erector Spinae Block Versus PENG Block for Postoperative Analgesia After Total Hip Replacement

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 13, 2023 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Papa Giovanni XXIII Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

THR (Total Hip Replacement) can be very painful and regional anesthesia is very effective in reducing postoperative pain. Erector Spinae Plane Block (ESPB) and PENG (pericapsular nerve group block) are alternative approaches to the hip sensitive nerve branches that resulted to be very promising for hip surgeries. However, no studies investigated the analgesic superiority of either PENG or ESPB. In our study the investigators compare PENG (with a lateral femoral cutaneous nerve block) and ESPB in terms of pain relief expressed as morphine consumption in the first 24 hours after primary THR.

6. Conditions and Keywords

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

Pain, Postoperative

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ERECTOR SPINAE PLANE BLOCK

Arm Type

Active Comparator

Arm Description

ultrasound guided block at L4

Arm Title

PERICAPSULARE NERVE GROUP AND LATERAL FEMORAL CUTANEOUS NERVE BLOCK

Arm Type

Active Comparator

Arm Description

ultrasound guided block below the ileo-psoas muscle tendon, above the ilio-pectineous eminence and ultrasound guided block of lateral femoral cutaneous nerve

Intervention Type

Procedure

Intervention Name(s)

ERECTOR SPINAE PLANE BLOCK

Intervention Description

ULTRASOUND GUIDED - ROPIVACAINE 30 ml 0.5%

Intervention Type

Procedure

Intervention Name(s)

Peng block + lateral femoral cutaneous nerve block

Intervention Description

ULTRASOUND GUIDED - ROPIVACAINE 20 ml 0.5% + 10 ml 0.5%

Intervention Type

Procedure

Intervention Name(s)

spinal anesthesia

Intervention Description

bupivacaine 0.5% 2.2 ml

Primary Outcome Measure Information:

Title

morphine consumption

Description

milligrams of morphine by patient controlled analgesia intravenously

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

postoperative pain

Description

numeric rating scale - NRS 11 point scale from 0 = "no pain" to 10 = "worst imaginable pain"

Time Frame

48 hours

Title

neuropathic pain

Description

DN4 questionnaire - 4 items questionnaire to investigate the occurrence of neuropathic component

Time Frame

48 hours

Title

postoperative complications

Description

nausea, vomiting, vertigo, blurred vision, syncope, bleeding, falls

Time Frame

48 hours

Title

chronic postoperative pain

Description

numeric rating scale 11 point scale from 0 = "no pain" to 10 = "worst imaginable pain"

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dario Bugada

Phone

+393405230454

dariobugada@gmail.com

Facility Information:

Facility Name

Aast Papa Giovanni Xxiii

City

Bergamo

ZIP/Postal Code

24127

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

DARIO BUGADA, MD

Phone

00390352675113

dariobugada@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Erector Spinae Block Versus PENG Block for Hip Replacement

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