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Pain Relief Results After Anterior Cruciate Ligament (ACL) Reconstruction

Primary Purpose

Anterior Cruciate Ligament Rupture

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Single-injection femoral nerve block
Femoral nerve block 60-hour continuous injection
Saline (control) injection into femoral nerve envelope
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Rupture focused on measuring ACL, Nerve block, Knee, Outcome survey, Anesthesia, Analgesia, Pain

Eligibility Criteria

14 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Pittsburgh Medical Center, Center for Sports Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

1

2

3

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pain scores during the first week after surgery

Secondary Outcome Measures

Side effects during the first week after surgery (nausea, vomiting, quality of sleep)
Determine the "rebound pain score" after a nerve block wears off
Skin reactions to the nerve block catehter dressing
Risk of falling
Validation of an 8-item outcome survey in comparison to a 40-item "gold standard" outcome survey
Study staffing costs before and after the implementation of HIPAA
Patient-reported general health status, and patient-reported knee function, during the first 12 weeks after surgery

Full Information

First Posted
August 14, 2001
Last Updated
May 2, 2013
Sponsor
University of Pittsburgh
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT00022854
Brief Title
Pain Relief Results After Anterior Cruciate Ligament (ACL) Reconstruction
Official Title
Outcomes After ACL Reconstruction: The Effect of Femoral Nerve Block Analgesia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
May 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Rupture
Keywords
ACL, Nerve block, Knee, Outcome survey, Anesthesia, Analgesia, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Title
2
Arm Type
Experimental
Arm Description
Nerve block bolus with 30 mL levobupivacaine 0.25%, followed by continuous saline infusion
Arm Title
3
Arm Type
Experimental
Arm Description
Nerve block bolus with 30 mL levobupivacaine 0.25%, followed by continuous levobupivacaine infusion of 5 mL/hr for 50 hr
Intervention Type
Procedure
Intervention Name(s)
Single-injection femoral nerve block
Intervention Description
Nerve block bolus with 30 mL levobupivacaine 0.25%, followed by continuous saline infusion
Intervention Type
Procedure
Intervention Name(s)
Femoral nerve block 60-hour continuous injection
Intervention Description
Nerve block bolus with 30 mL levobupivacaine 0.25%, followed by continuous infusion (5 mL/hr for 50 hours) of 0.25% levobupivacaine
Intervention Type
Procedure
Intervention Name(s)
Saline (control) injection into femoral nerve envelope
Intervention Description
Nerve block bolus with 30 mL saline, followed by continuous saline infusion
Primary Outcome Measure Information:
Title
Pain scores during the first week after surgery
Time Frame
one week
Secondary Outcome Measure Information:
Title
Side effects during the first week after surgery (nausea, vomiting, quality of sleep)
Time Frame
first week after surgery
Title
Determine the "rebound pain score" after a nerve block wears off
Time Frame
first week after surgery
Title
Skin reactions to the nerve block catehter dressing
Time Frame
first week after surgery
Title
Risk of falling
Time Frame
first week after surgery
Title
Validation of an 8-item outcome survey in comparison to a 40-item "gold standard" outcome survey
Time Frame
first week after surgery
Title
Study staffing costs before and after the implementation of HIPAA
Time Frame
the 40 months of study recruitment
Title
Patient-reported general health status, and patient-reported knee function, during the first 12 weeks after surgery
Time Frame
up to 12 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian A. Williams, MD, MBA
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center, Center for Sports Medicine
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15203
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
10910504
Citation
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.
Results Reference
background
PubMed Identifier
12357168
Citation
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.
Results Reference
background
PubMed Identifier
12717143
Citation
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.
Results Reference
background
PubMed Identifier
15108988
Citation
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.
Results Reference
background
PubMed Identifier
16436852
Citation
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.
Results Reference
result
PubMed Identifier
17543813
Citation
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.
Results Reference
result
PubMed Identifier
17543812
Citation
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.
Results Reference
result
PubMed Identifier
18042869
Citation
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.
Results Reference
result
PubMed Identifier
17377133
Citation
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.
Results Reference
result
PubMed Identifier
17456710
Citation
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.
Results Reference
result
PubMed Identifier
18073577
Citation
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.
Results Reference
result

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Pain Relief Results After Anterior Cruciate Ligament (ACL) Reconstruction

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