NCT02606448

Brief Summary

This is a randomized, single blinded, standard of care controlled clinical trial. All adult patients over sixteen desiring anterior cruciate ligament reconstruction will be eligible. The study compares pain control and opioid consumption in patients undergoing ACL reconstruction between patients receiving liposomal bupivacaine and those who underwent a preoperative femoral nerve block.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for phase_4 pain

Timeline
Completed

Started Aug 2014

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 5, 2015

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 17, 2015

Completed
Last Updated

December 8, 2023

Status Verified

December 1, 2023

Enrollment Period

1.1 years

First QC Date

October 5, 2015

Last Update Submit

December 1, 2023

Conditions

Pain

Keywords

pain controlpatient satisfactionliposomal bupivacaineAnterior cruciate ligament reconstruction

Outcome Measures

Primary Outcomes (1)

  • Pain levels

    Patients recorded pain lvls every four hours using VAS scales for four days post operatively

    4 days postoperatively

Secondary Outcomes (1)

  • Morphine equivalents

    4 days postoperatively

Study Arms (2)

Femoral Nerve Block

ACTIVE COMPARATOR

Patients in this group received preoperative ultrasound guided femoral nerve blocks by senior anesthesiologist using ropivicaine.

Procedure: Femoral nerve blockDrug: Ropivacaine

Liposomal Bupivacaine

EXPERIMENTAL

Patients in this group received local infiltration of Liposomal bupivacaine before the end of surgery.

Drug: Liposomal bupivacaine

Interventions

Liposomal bupivacaineDRUG

Local infiltration of liposomal bupivacaine

Also known as: Exparel
Liposomal Bupivacaine
Femoral nerve blockPROCEDURE

Pre-operative femoral nerve block

Femoral Nerve Block
RopivacaineDRUG

Ropivicaine was used in all femoral nerve blocks

Femoral Nerve Block

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PainAgnosiaPatient Satisfaction

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sub Investigator

Study Record Dates

First Submitted

October 5, 2015

First Posted

November 17, 2015

Study Start

August 1, 2014

Primary Completion

September 1, 2015

Study Completion

November 1, 2015

Last Updated

December 8, 2023

Record last verified: 2023-12