NCT03691337

Brief Summary

The development of minimal-incision techniques for total hip arthroplasty (THA) with preservation of soft tissue is generally associated with reduction of postoperative pain and increased patient comfort. Although this technique requires a smaller incision than other approaches used for hip surgery, adequate postoperative pain management remains crucial for enhanced recovery and early rehabilitation. The fascia iliaca block (FIB) is commonly used to enhance analgesia after hip replacement surgery, however the effect of FIB volume on analgesia quality and sensory-motor blockade have not been adequately studied. In this study, total postsurgical opioid consumption (morphine equivalents IV in hospital and oral at home) through the first postoperative week will be compared and extent and duration of sensory motor block through the 2-day inpatient stay will be evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2018

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

Study Start

First participant enrolled

May 15, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 1, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2019

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2019

Completed
Last Updated

September 10, 2020

Status Verified

September 1, 2020

Enrollment Period

1.5 years

First QC Date

August 1, 2018

Last Update Submit

September 9, 2020

Conditions

THA

Outcome Measures

Primary Outcomes (15)

  • Current pain assessed by numeric rating scale (NRS)

    Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with movement

    Day 0

  • Current pain assessed by numeric rating scale (NRS)

    Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with

    PACU arrival

  • Current pain assessed by numeric rating scale (NRS)

    Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with

    PACU discharge

  • Current pain assessed by numeric rating scale (NRS)

    Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with

    6 hours

  • Current pain assessed by numeric rating scale (NRS)

    Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with

    12 hours

  • Current pain assessed by numeric rating scale (NRS)

    Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with

    24 hours

  • Current pain assessed by numeric rating scale (NRS)

    Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with

    36 hours

  • Current pain assessed by numeric rating scale (NRS)

    Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with

    48 hours

  • Current pain assessed by numeric rating scale (NRS)

    Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with

    Day 2 evening

  • Current pain assessed by numeric rating scale (NRS)

    Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with

    Day 3 morning

  • Current pain assessed by numeric rating scale (NRS)

    Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with

    Day 3 evening

  • Current pain assessed by numeric rating scale (NRS)

    Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with

    Day 4

  • Current pain assessed by numeric rating scale (NRS)

    Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with

    Day 5

  • Current pain assessed by numeric rating scale (NRS)

    Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with

    Day 6

  • Current pain assessed by numeric rating scale (NRS)

    Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with

    Day 7

Secondary Outcomes (22)

  • Total opioid consumption

    PACU arrival

  • Total opioid consumption

    PACU discharge

  • Total opioid consumption

    6 hours

  • Total opioid consumption

    12 hours

  • Total opioid consumption

    24 hours

  • +17 more secondary outcomes

Study Arms (3)

Low dosis bupivacaine

ACTIVE COMPARATOR

Preoperative fascia iliaca block with Marcaine 0.25% (0.11 mL x subject height)

Drug: Marcaine 0.25 % Injectable Solution

High dosis bupivacaine

ACTIVE COMPARATOR

Preoperative fascia iliaca block with Marcaine 0.25% (0.22 mL x subject height)

Drug: Marcaine 0.25 % Injectable Solution

Placebo

PLACEBO COMPARATOR

Preoperative fascia iliaca block with Sodium Chloride 0.9% (0.11 mL x subject height)

Drug: Sodium chloride

Interventions

Marcaine 0.25 % Injectable SolutionDRUG

Fascia iliaca block with volume 0.11 mL x subject height

Low dosis bupivacaine
Sodium chlorideDRUG

Fascia iliaca block with volume 0.11 mL x subject height

Placebo

Eligibility Criteria

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

You may qualify if:

  • Male or female, at least 18 years of age at screening
  • Scheduled for unilateral DAA THA
  • American Society of Anesthesiologists (ASA) physical status 1, 2 or 3
  • Able to demonstrate sensory function by exhibiting sensitivity to light touch, pinprick and cold
  • Able to ambulate
  • Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments

You may not qualify if:

  • Previous open hip surgery
  • History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics
  • Contraindication to bupivacaine or morphine
  • Concurrent physical condition that may require analgesic treatment (such as NSAID or opioid) in the postsurgical period for pain that is not strictly related to the hip surgery and which may confound the postsurgical assessments
  • Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®)
  • Body weight \<40 kg (88 pounds) or a body mass index \>44 kg/m2
  • Uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, Limburg, B-3600, Belgium

Location

MeSH Terms

Interventions

BupivacaineSodium Chloride

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

August 1, 2018

First Posted

October 1, 2018

Study Start

May 15, 2018

Primary Completion

November 12, 2019

Study Completion

December 4, 2019

Last Updated

September 10, 2020

Record last verified: 2020-09

Locations

BE(1)