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

July 27, 2024 updated by: Dario Bugada, Papa Giovanni XXIII Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bergamo, Italy, 24127
        • Aast Papa Giovanni Xxiii

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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: spinal anesthesia
bupivacaine 0.5% 2.2 ml
Procedure: Peng block + lateral femoral cutaneous nerve block
ULTRASOUND GUIDED - ROPIVACAINE 20 ml 0.5% + 10 ml 0.5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
morphine consumption
Time Frame: 24 hours
milligrams of morphine by patient controlled analgesia intravenously
24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Papa Giovanni XXIII Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2023

Primary Completion (Actual)

February 23, 2024

Study Completion (Actual)

May 23, 2024

Study Registration Dates

First Submitted

March 21, 2023

First Submitted That Met QC Criteria

March 21, 2023

First Posted (Actual)

April 4, 2023

Study Record Updates

Last Update Posted (Actual)

July 30, 2024

Last Update Submitted That Met QC Criteria

July 27, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 030/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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