Effectiveness of Continuous Femoral Nerve Block Versus Single Shot Femoral Nerve Block for Pain Control

NCT01916590 | Terminated Results

• 1 other identifier: 11-0847
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Both single shot femoral nerve block and continuous femoral nerve block with catheter have been shown to be effective for pain control after anterior cruciate ligament reconstruction (ACLR). Continuous femoral nerve block may be the more effective of the two in reducing pain scores and opioid consumption for the first 48 hours postoperatively.

Conditions

Post-operative Pain

Keywords

Post-operative pain; Anterior Cruciate Ligament repair

Outcome Measures

Primary Outcomes (1)

• Pain Scores Will be Collected for 48 Hours After ACL Reconstruction

  Pain scores will be collected for 48 hours after ACL reconstruction with a patellar tendon graft or allograft and used to measure the effectiveness of the femoral catheter vs. single shot femoral nerve block

  48 hours after surgery

Study Arms (2)

Bupivacaine

ACTIVE COMPARATOR

All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine)through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter.

Drug: Bupivicaine

Placebo

PLACEBO COMPARATOR

All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine) through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with saline solution, and the infusion will be started at 6 ml/hr. gh the catheter.

Drug: placebo

Interventions

Bupivicaine DRUG

After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter.

Bupivacaine

placebo DRUG

Placebo

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists score between 1-3
• Scheduled to undergo Anterior Cruciate Ligament reconstruction with patellar tendon graft or allograft under general anesthesia

You may not qualify if:

• Localized infection of the groin or generalized sepsis.
• Hypersensitivity or known allergy to local anesthetics.
• Preexisting nerve damage in surgical limb.
• History of chronic pain with either (a) daily opioid requirement exceeding the equivalent of 50 mg morphine or (b) daily prescription of tricyclic antidepressants, gabapentin, pregabalin, or tramadol for pain.
• Patients who elect to have knee surgery under spinal anesthesia or who cannot undergo general anesthetic.
• Patients who decline to have a femoral nerve block with catheter.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Limitations and Caveats

Serious and Other (Not Including Serious) Adverse Events were not monitored/collected for the 7 enrolled participants.

Results Point of Contact

• Title: Colleen Dingmann R.N. Ph.D.
• Organization: UColorado

colleen.dingmann@ucdenver.edu

303-724-7494

Study Officials

• Matthew Fiegel, M.D.

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2013
• First Posted: August 5, 2013
• Study Start: July 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: August 1, 2016
• Results First Posted: August 1, 2016

Record last verified: 2016-06

Locations

US (1)