NCT01447277

Brief Summary

The investigators propose that a preoperative femoral and sciatic blocks vs a femoral block only, prior to ambulatory anterior cruciate ligament (ACL) reconstruction will lead to a decrease in opiate consumption, pain scores, and post-anesthesia care unit (PACU) length of stay. The investigators are prospectively randomizing patients to either a femoral or a fem/sciatic block and monitor outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2011

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

September 30, 2011

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 6, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

February 21, 2020

Status Verified

February 1, 2020

Enrollment Period

1.6 years

First QC Date

September 30, 2011

Last Update Submit

February 20, 2020

Conditions

Anterior Cruciate Ligament Tear

Keywords

ACL reconstructionFemoral BlockSciatic Block

Outcome Measures

Primary Outcomes (1)

  • Pain Scores

    PACU and POD1, 2 and 3.

Secondary Outcomes (3)

  • Length of stay

    Duration of stay in the recovery room

  • Opiate consumption

    During surgery, recovery room and for 3 days after discharge

  • PONV

    During the recovery room stay and after discharge from surgery center for up to 3 days.

Study Arms (2)

Femoral and Sciatic Block

EXPERIMENTAL

Administration of preoperative femoral and sciatic nerve blocks

Procedure: Sciatic Block

Femoral Block Only

OTHER

Administration of a femoral nerve block prior to surgery

Procedure: Femoral Block only

Interventions

Sciatic BlockPROCEDURE

Performing a sciatic block in addition to a femoral block preoperatively

Femoral and Sciatic Block
Femoral Block onlyPROCEDURE

Performing a preoperative sciatic nerve block only

Femoral Block Only

Eligibility Criteria

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

You may qualify if:

  • Age 18 and over
  • ASA status I-II
  • Scheduled for ambulatory Arthroscopic ACL Surgery

You may not qualify if:

  • Allergy to Local anesthetics or opiates used in the study
  • Contraindications for regional anesthesia
  • coagulopathy, anticoagulation, Thrombocytopenia
  • infection at site of injection
  • Chronic pain and high preoperative opiate requirements
  • High risk for PONV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF Orthopedic Institute

San Francisco, California, 94158, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2011

First Posted

October 6, 2011

Study Start

October 1, 2011

Primary Completion

May 1, 2013

Study Completion

June 1, 2013

Last Updated

February 21, 2020

Record last verified: 2020-02

Locations

US(1)