NCT05796804

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 4, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

April 13, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2024

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

11 months

First QC Date

March 21, 2023

Last Update Submit

July 27, 2024

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • morphine consumption

    milligrams of morphine by patient controlled analgesia intravenously

    24 hours

Secondary Outcomes (4)

  • postoperative pain

    48 hours

  • neuropathic pain

    48 hours

  • postoperative complications

    48 hours

  • chronic postoperative pain

    3 months

Study Arms (2)

ERECTOR SPINAE PLANE BLOCK

ACTIVE COMPARATOR

ultrasound guided block at L4

Procedure: ERECTOR SPINAE PLANE BLOCKProcedure: spinal anesthesia

PERICAPSULARE NERVE GROUP AND LATERAL FEMORAL CUTANEOUS NERVE BLOCK

ACTIVE COMPARATOR

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 blockProcedure: spinal anesthesia

Interventions

ERECTOR SPINAE PLANE BLOCKPROCEDURE

ULTRASOUND GUIDED - ROPIVACAINE 30 ml 0.5%

ERECTOR SPINAE PLANE BLOCK
Peng block + lateral femoral cutaneous nerve blockPROCEDURE

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

PERICAPSULARE NERVE GROUP AND LATERAL FEMORAL CUTANEOUS NERVE BLOCK
spinal anesthesiaPROCEDURE

bupivacaine 0.5% 2.2 ml

ERECTOR SPINAE PLANE BLOCKPERICAPSULARE NERVE GROUP AND LATERAL FEMORAL CUTANEOUS NERVE BLOCK

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary total hip replacement
  • informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aast Papa Giovanni Xxiii

Bergamo, 24127, Italy

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 21, 2023

First Posted

April 4, 2023

Study Start

April 13, 2023

Primary Completion

February 23, 2024

Study Completion

May 23, 2024

Last Updated

July 30, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)