PENGESP: Erector Spinae Block Versus PENG Block for Hip Replacement

Sponsor

Papa Giovanni XXIII Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05796804

Collaborator

(none)

Enrollment

Location

Arms

12.1

Anticipated Duration (Months)

5.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	Procedure: ERECTOR SPINAE PLANE BLOCK Procedure: Peng block + lateral femoral cutaneous nerve block Procedure: spinal anesthesia	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 30, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Mar 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ERECTOR SPINAE PLANE BLOCK ultrasound guided block at L4	Procedure: ERECTOR SPINAE PLANE BLOCK ULTRASOUND GUIDED - ROPIVACAINE 30 ml 0.5% Procedure: spinal anesthesia bupivacaine 0.5% 2.2 ml
Active Comparator: PERICAPSULARE NERVE GROUP AND LATERAL FEMORAL CUTANEOUS NERVE BLOCK ultrasound guided block below the ileo-psoas muscle tendon, above the ilio-pectineous eminence and ultrasound guided block of lateral femoral cutaneous nerve	Procedure: Peng block + lateral femoral cutaneous nerve block ULTRASOUND GUIDED - ROPIVACAINE 20 ml 0.5% + 10 ml 0.5% Procedure: spinal anesthesia bupivacaine 0.5% 2.2 ml

Arm

Intervention/Treatment

Active Comparator: ERECTOR SPINAE PLANE BLOCK

ultrasound guided block at L4

Procedure: ERECTOR SPINAE PLANE BLOCK

ULTRASOUND GUIDED - ROPIVACAINE 30 ml 0.5%

Procedure: spinal anesthesia

bupivacaine 0.5% 2.2 ml

Active Comparator: PERICAPSULARE NERVE GROUP AND LATERAL FEMORAL CUTANEOUS NERVE BLOCK

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

Procedure: Peng block + lateral femoral cutaneous nerve block

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

Procedure: spinal anesthesia

bupivacaine 0.5% 2.2 ml

Outcome Measures

Primary Outcome Measures

morphine consumption [24 hours]
milligrams of morphine by patient controlled analgesia intravenously

Secondary Outcome Measures

postoperative pain [48 hours]
numeric rating scale - NRS 11 point scale from 0 = "no pain" to 10 = "worst imaginable pain"
neuropathic pain [48 hours]
DN4 questionnaire - 4 items questionnaire to investigate the occurrence of neuropathic component
postoperative complications [48 hours]
nausea, vomiting, vertigo, blurred vision, syncope, bleeding, falls
chronic postoperative pain [3 months]
numeric rating scale 11 point scale from 0 = "no pain" to 10 = "worst imaginable pain"

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aast Papa Giovanni Xxiii	Bergamo		Italy	24127

Sponsors and Collaborators

Papa Giovanni XXIII Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dario Bugada, MD, Papa Giovanni XXIII Hospital

ClinicalTrials.gov Identifier:

NCT05796804

Other Study ID Numbers:

030/23

First Posted:

Apr 4, 2023

Last Update Posted:

Apr 6, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Anesthetics

Study Results

No Results Posted as of Apr 6, 2023