Pain Relief Results After Anterior Cruciate Ligament (ACL) Reconstruction

University of Pittsburgh

Status and phase: Completed; Phase 4

Conditions: Anterior Cruciate Ligament Rupture

Treatments: Procedure: Femoral nerve block 60-hour continuous injection; Procedure: Saline (control) injection into femoral nerve envelope; Procedure: Single-injection femoral nerve block

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00022854

NIAMS-066

K23AR047631 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Anterior cruciate ligament (ACL) reconstruction is surgery that is done to repair a damaged ligament in the knee. In this study we will look at whether the femoral nerve block, a commonly used method for pain relief after ACL reconstruction, affects the way patients feel after surgery. We will study recovery during the first week after surgery and also 3-12 weeks after surgery. We will give all patients spinal anesthesia. Some patients will also receive a continuous femoral nerve block for 2 days, or by a single injection. We predict that patients who received the nerve block will have significantly improved pain results, compared to patients who did not receive the nerve block.

Full description

In this project, we will measure outcomes of anesthesia and pain management for common orthopedic procedures. The influence of nerve block pain management on outcomes after outpatient anterior cruciate ligament (ACL) reconstruction has not been studied, especially the patient's potential to return to societal productivity during the first week after surgery. Therefore, we have designed a randomized clinical trial to study the role of nerve block pain management techniques on patient outcomes during the first week after surgery and on recovery 3-12 weeks after surgery. Our hypothesis is that patients undergoing nerve block analgesia will manifest better self-reported recovery outcomes, physical function outcomes, and objective measures of neuromuscular function.

We will give consenting patients (n=270) undergoing ACL reconstruction conventional spinal anesthesia and will randomize them to receive femoral nerve block analgesia with either a single injection, a continuous infusion for 2 days, or saline placebo. We will use goniometry to test postoperative range of motion in extension to determine whether the quadriceps femoris torque output is impaired. We will compare patient-reported recovery outcomes across treatment groups using three validated health status measures suitable for daily assessment (Verbal Pain Score, SF-8, and the Quality of Recovery [from anesthesia, QoR-40] Score).

We aim to determine the quality of immediate recovery from anesthesia and the extent of reported pain. We will compare the effects of single injection and continuous infusion on femoral nerve analgesia to determine the better dosing strategy for these patients.

Enrollment: 270 patients

Sex: All

Ages: 14 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 14-65
• Undergoing ACL reconstruction at the University of Pittsburgh
• Agrees to spinal anesthesia and consents to one of the three nerve block interventions.
• Agrees to visit the University of Pittsburgh Center for Rehabilitation Services for postoperative physical therapy and rehabilitation (for standardized rehabilitation protocols)

Exclusion criteria

• Morbid obesity
• Chronic pain syndromes
• Opioid dependence
• Corticosteroid prescriptions
• Tricyclic antidepressant prescriptions
• Tramadol prescriptions
• Preexisting neuropathies
• Poorly controlled diabetes mellitus
• Poorly controlled anxiety disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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270 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Procedure: Saline (control) injection into femoral nerve envelope

2

Experimental group

Description:

Nerve block bolus with 30 mL levobupivacaine 0.25%, followed by continuous saline infusion

Treatment:

Procedure: Single-injection femoral nerve block

3

Experimental group

Description:

Nerve block bolus with 30 mL levobupivacaine 0.25%, followed by continuous levobupivacaine infusion of 5 mL/hr for 50 hr

Treatment:

Procedure: Femoral nerve block 60-hour continuous injection