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

Post-operative Pain Clinical Trial

Official title:

Effectiveness of Continuous Femoral Nerve Block Versus Single Shot Femoral Nerve Block for Pain Control After Anterior Cruciate Ligament Reconstruction With Patellar Tendon Graft or Allograft

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01916590
• Other study ID #: 11-0847
• Status: Terminated
• Phase: N/A
• First received: July 30, 2013
• Last updated: October 5, 2015
• Start date: July 2011
• Est. completion date: May 2014

Study information

• Verified date: October 2015
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

The number of ambulatory procedures has steadily increased over the last decade. Postoperative pain is the most common cause of delayed discharge and unexpected admission after ambulatory surgery. Knee surgery was identified as one of the procedures associated with the most pain at 24 hours, with a 45% or higher incidence of moderate or severe pain. Poor pain control can counteract many of the benefits of ambulatory surgery and can lead to the development of chronic pain.

Regional techniques have been shown to be effective after ACL reconstruction, allowing faster patient recovery with fewer side-effects than intravenous administration of opioids. Different regional techniques have been applied and studied after ACLR. Femoral nerve block for ACLR either as a single bolus or as a continuous infusion markedly decreases intravenous analgesic requirements and postoperative pain. To our knowledge, no study has compared these two techniques after ACLR with patellar tendon graft or allograft.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

1. American Society of Anesthesiologists score between 1-3

2. Scheduled to undergo Anterior Cruciate Ligament reconstruction with patellar tendon graft or allograft under general anesthesia

Exclusion Criteria:

1. Localized infection of the groin or generalized sepsis.

2. Hypersensitivity or known allergy to local anesthetics.

3. Preexisting nerve damage in surgical limb.

4. 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.

5. Patients who elect to have knee surgery under spinal anesthesia or who cannot undergo general anesthetic.

6. Patients who decline to have a femoral nerve block with catheter.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-operative Pain

Intervention

Drug:
• Bupivicaine
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.
• placebo

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scores will be collected for 48 hours after ACL reconstruction	Pain scores will be collected for 48 hours after ACL reconstruction with 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	No
Secondary	Doses of pain medications taken will be collected for 48 hours after ACL reconstruction.	Dose of pain medications will be collected for 48 hours after ACL reconstruction with patellar tendon graft or allograft and used to measure the effectiveness of the femoral catheter vs. single shot femoral nerve block.	First 48 hours after surgery	No
Secondary	Patient satisfaction will be collected for 48 hours after ACL reconstruction.	Patient satisfaction will be collected for 48 hours after ACL reconstruction with patellar tendon graft or allograft and used to measure the effectiveness of the femoral catheter vs. single shot femoral nerve block.	First 48 hours after surgery	No