NCT04574154

Brief Summary

THR (Total Hip Replacement) can be very painful and regional anesthesia is very effective in reducing postoperative pain. Fascia Iliaca Block (FIB) and Erector Spinae Plane Block (ESPB) are indirect approaches to the lumbar plexus that resulted to be very promising for THR. However, no studies investigated the analgesic superiority of either FIB or ESPB. In our study the investigators compare FIB 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 P25-P50 for not_applicable postoperative-pain

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable postoperative-pain

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

January 8, 2020

Completed
12 days until next milestone

Study Start

First participant enrolled

January 20, 2020

Completed
9 months until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2021

Completed
Last Updated

December 9, 2021

Status Verified

November 1, 2021

Enrollment Period

1.3 years

First QC Date

January 8, 2020

Last Update Submit

November 28, 2021

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • morphine

    milligrams of morphine consumed in the first postoperative day

    24 hours

Secondary Outcomes (3)

  • perceived postoperative pain: Numeric Rating Scale (NRS)

    24 hs

  • perceived postoperative pain: Numeric Rating Scale (NRS)

    48 hours

  • side effects

    48 hours

Study Arms (2)

FIB

EXPERIMENTAL

ultrasound guided Fascia Iliaca Block

Procedure: FIBProcedure: spinal anesthesia

ESPB

EXPERIMENTAL

ultrasound guided Erector Spinae Plane Block

Procedure: ESPBProcedure: spinal anesthesia

Interventions

FIBPROCEDURE

FIB with ultrasound: Ropivacaine 0.5% 40 ml

FIB
ESPBPROCEDURE

ESPB (L4) with ultrasound: Ropivacaine 0.5% 40 ml

ESPB
spinal anesthesiaPROCEDURE

bupivacaine 0,5% 2.2 ml

ESPBFIB

Eligibility Criteria

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

You may qualify if:

  • primary THR
  • 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
Model Details: randomized trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD, principal investigator, attending anesthesiologist

Study Record Dates

First Submitted

January 8, 2020

First Posted

October 5, 2020

Study Start

January 20, 2020

Primary Completion

May 15, 2021

Study Completion

August 21, 2021

Last Updated

December 9, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)