Pain Relief Results After Anterior Cruciate Ligament (ACL) Reconstruction

NCT00022854 | Completed Phase 4 DMC

• 2 other identifiers: K23AR047631NIAMS-066
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anterior Cruciate Ligament Rupture

Keywords

ACL; Nerve block; Knee; Outcome survey; Anesthesia; Analgesia; Pain

Outcome Measures

Primary Outcomes (1)

• Pain scores during the first week after surgery

  one week

Secondary Outcomes (7)

• Side effects during the first week after surgery (nausea, vomiting, quality of sleep)

  first week after surgery

• Determine the "rebound pain score" after a nerve block wears off

  first week after surgery

• Skin reactions to the nerve block catehter dressing

  first week after surgery

• Risk of falling

  first week after surgery

• Validation of an 8-item outcome survey in comparison to a 40-item "gold standard" outcome survey

  first week after surgery

Study Arms (3)

1

PLACEBO COMPARATOR

Procedure: Saline (control) injection into femoral nerve envelope

2

EXPERIMENTAL

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

Procedure: Single-injection femoral nerve block

3

EXPERIMENTAL

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

Procedure: Femoral nerve block 60-hour continuous injection

Interventions

Single-injection femoral nerve block PROCEDURE

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

2

Femoral nerve block 60-hour continuous injection PROCEDURE

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

3

Saline (control) injection into femoral nerve envelope PROCEDURE

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

1

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

University of Pittsburgh Medical Center, Center for Sports Medicine

Pittsburgh, Pennsylvania, 15203, United States

Location

Related Publications (11)

• Williams BA, Kentor ML, Williams JP, Figallo CM, Sigl JC, Anders JW, Bear TC, Tullock WC, Bennett CH, Harner CD, Fu FH. Process analysis in outpatient knee surgery: effects of regional and general anesthesia on anesthesia-controlled time. Anesthesiology. 2000 Aug;93(2):529-38. doi: 10.1097/00000542-200008000-00033.

  PMID: 10910504 BACKGROUND

• Williams BA, Kentor ML, Williams JP, Vogt MT, DaPos SV, Harner CD, Fu FH. PACU bypass after outpatient knee surgery is associated with fewer unplanned hospital admissions but more phase II nursing interventions. Anesthesiology. 2002 Oct;97(4):981-8. doi: 10.1097/00000542-200210000-00034.

  PMID: 12357168 BACKGROUND

• Williams BA, Kentor ML, Vogt MT, Williams JP, Chelly JE, Valalik S, Harner CD, Fu FH. Femoral-sciatic nerve blocks for complex outpatient knee surgery are associated with less postoperative pain before same-day discharge: a review of 1,200 consecutive cases from the period 1996-1999. Anesthesiology. 2003 May;98(5):1206-13. doi: 10.1097/00000542-200305000-00024.

  PMID: 12717143 BACKGROUND

• Williams BA, Kentor ML, Vogt MT, Vogt WB, Coley KC, Williams JP, Roberts MS, Chelly JE, Harner CD, Fu FH. Economics of nerve block pain management after anterior cruciate ligament reconstruction: potential hospital cost savings via associated postanesthesia care unit bypass and same-day discharge. Anesthesiology. 2004 Mar;100(3):697-706. doi: 10.1097/00000542-200403000-00034.

  PMID: 15108988 BACKGROUND

• Williams BA, Kentor ML, Vogt MT, Irrgang JJ, Bottegal MT, West RV, Harner CD, Fu FH, Williams JP. Reduction of verbal pain scores after anterior cruciate ligament reconstruction with 2-day continuous femoral nerve block: a randomized clinical trial. Anesthesiology. 2006 Feb;104(2):315-27. doi: 10.1097/00000542-200602000-00018.

  PMID: 16436852 RESULT

• Williams BA, Kentor ML, Irrgang JJ, Bottegal MT, Williams JP. Nausea, vomiting, sleep, and restfulness upon discharge home after outpatient anterior cruciate ligament reconstruction with regional anesthesia and multimodal analgesia/antiemesis. Reg Anesth Pain Med. 2007 May-Jun;32(3):193-202. doi: 10.1016/j.rapm.2006.12.002.

  PMID: 17543813 RESULT

• Williams BA, Bottegal MT, Kentor ML, Irrgang JJ, Williams JP. Rebound pain scores as a function of femoral nerve block duration after anterior cruciate ligament reconstruction: retrospective analysis of a prospective, randomized clinical trial. Reg Anesth Pain Med. 2007 May-Jun;32(3):186-92. doi: 10.1016/j.rapm.2006.10.011.

  PMID: 17543812 RESULT

• Bost JE, Williams BA, Bottegal MT, Dang Q, Rubio DM. The 8-item Short-Form Health Survey and the physical comfort composite score of the quality of recovery 40-item scale provide the most responsive assessments of pain, physical function, and mental function during the first 4 days after ambulatory knee surgery with regional anesthesia. Anesth Analg. 2007 Dec;105(6):1693-700, table of contents. doi: 10.1213/01.ane.0000287659.14893.65.

  PMID: 18042869 RESULT

• Williams BA, Kentor ML, Bottegal MT. The incidence of falls at home in patients with perineural femoral catheters: a retrospective summary of a randomized clinical trial. Anesth Analg. 2007 Apr;104(4):1002. doi: 10.1213/01.ane.0000256006.46703.7f. No abstract available.

  PMID: 17377133 RESULT

• Williams BA, Bolland MA, Orebaugh SL, Bottegal MT, Kentor ML. Skin reactions at the femoral perineural catheter insertion site: retrospective summary of a randomized clinical trial. Anesth Analg. 2007 May;104(5):1309-10. doi: 10.1213/01.ane.0000260353.11142.d4. No abstract available.

  PMID: 17456710 RESULT

• Williams BA, Bottegal MT, Francis KA, Irrgang JJ, Vogt MT. A post hoc analysis of research study staffing: budgetary effects of the Health Insurance Portability and Accountability Act on research staff work hours during a prospective, randomized clinical trial. Anesthesiology. 2007 Nov;107(5):860-1. doi: 10.1097/01.anes.0000287212.90397.6b. No abstract available.

  PMID: 18073577 RESULT

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Agnosia; Pain

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Brian A. Williams, MD, MBA

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2001
• First Posted: August 16, 2001
• Study Start: May 1, 2001
• Study Completion: January 1, 2005
• Last Updated: May 3, 2013

Record last verified: 2013-05

Locations

US (1)