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Fascia Iliaca Compartment Block in Acute and Chronic Pain Management in Hip Fracture Patients

Primary Purpose

Chronic Hip Pain

Status

Completed

Phase

Not Applicable

Locations

Greece

Study Type

Interventional

Intervention

Fascia iliaca compartment block

Ropivacaine

ultrasound

Placebo

About this trial

This is an interventional prevention trial for Chronic Hip Pain

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

ASA I-III (American Society of Anesthesiologists classification)
intertrochanteric fractures
fractures of femoral neck

Exclusion Criteria:

existing pain in hip Joint to be operated
cognitive or mental disorder
administration of analgesic drugs prior surgery
contraindications of spinal anesthesia
refusal to participate in the study

Sites / Locations

Asklepieion General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Fascia iliaca compartment block (FICB)

Placebo (not FICB)

Arm Description

Under ultrasound guidance performing fascia iliaca compartment block, in which 40 ml ropivacaine 0,5% are injected under the fascia iliaca.

Half of the patients will not receive FICB

Outcomes

Primary Outcome Measures

Acute postsurgical pain after hip fracture surgery

Acute pain will be evaluated using the Numeric Rating Scale- NRS (0=no pain, 10= Extremely strong pain) at rest and in motion.

Chronic postsurgical pain after hip fracture surgery

3 and 6 months after surgery the patient or patient's relative will be asked on telephone to complete Von Korff Graded Chronic scale modified for hip pain

Secondary Outcome Measures

Full Information

NCT ID

NCT02479828

First Posted

June 10, 2015

Last Updated

March 11, 2019

Sponsor

Asklepieion Voulas General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02479828

Brief Title

Fascia Iliaca Compartment Block in Acute and Chronic Pain Management in Hip Fracture Patients

Official Title

The Effect of Fascia Iliaca Compartment Block in Acute and Chronic Pain Management in Hip Fracture Patients

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

June 2015 (Actual)

Primary Completion Date

January 2018 (Actual)

Study Completion Date

January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Asklepieion Voulas General Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study evaluates the effect of fascia iliaca compartment block (FICB) in the management of acute post -surgical pain in hip fracture patients and in the appearance of chronic post -surgical hip pain, by means of von Korff Graded Chronic Pain Scale -modified for hip pain in Greek. Half of the patients will not receive fascia iliaca compartment block.

6. Conditions and Keywords

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

Chronic Hip Pain

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

198 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fascia iliaca compartment block (FICB)

Arm Type

Active Comparator

Arm Description

Under ultrasound guidance performing fascia iliaca compartment block, in which 40 ml ropivacaine 0,5% are injected under the fascia iliaca.

Arm Title

Placebo (not FICB)

Arm Type

Placebo Comparator

Arm Description

Half of the patients will not receive FICB

Intervention Type

Drug

Intervention Name(s)

Fascia iliaca compartment block

Intervention Description

40 ml ropivacaine 0,5% injected under fascia iliaca using ultrasound

Intervention Type

Drug

Intervention Name(s)

Ropivacaine

Intervention Type

Device

Intervention Name(s)

ultrasound

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Acute postsurgical pain after hip fracture surgery

Description

Acute pain will be evaluated using the Numeric Rating Scale- NRS (0=no pain, 10= Extremely strong pain) at rest and in motion.

Time Frame

48 hours

Title

Chronic postsurgical pain after hip fracture surgery

Description

3 and 6 months after surgery the patient or patient's relative will be asked on telephone to complete Von Korff Graded Chronic scale modified for hip pain

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ASA I-III (American Society of Anesthesiologists classification) intertrochanteric fractures fractures of femoral neck Exclusion Criteria: existing pain in hip Joint to be operated cognitive or mental disorder administration of analgesic drugs prior surgery contraindications of spinal anesthesia refusal to participate in the study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

MARIA DIAKOMI

Organizational Affiliation

Asklepieion General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Asklepieion General Hospital

City

Athens

State/Province

Voula

ZIP/Postal Code

16673

Country

Greece

12. IPD Sharing Statement

Citations:

PubMed Identifier

33238043

Citation

Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.

Results Reference

derived

Learn more about this trial

Fascia Iliaca Compartment Block in Acute and Chronic Pain Management in Hip Fracture Patients

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