ACL Repair and Multimodal Analgesia

NCT ID: NCT01868425

Last Updated: 2020-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2017-12-31

Brief Summary

This study will evaluate the effectiveness of an aggressive multimodal regimen versus standard multimodal for Anterior Cruciate Ligament (ACL) repair using hamstring graft for patients having surgery in our outpatient surgicenter.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

multimodal:acetaminophen, gabapentin, ketamine, bupivacaine

aggressive multimodal plus standard care, which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane

Group Type: EXPERIMENTAL

multimodal:acetaminophen, gabapentin, ketamine, bupivacaine

Intervention Type: DRUG

acetaminophen, gabapentin, ketamine, bupivacaine and standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane

placebo pills and injectables

standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane

Group Type: PLACEBO_COMPARATOR

placebo pills and injectables

Intervention Type: DRUG

receives standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane plus placebos of intervention arm meds

Interventions

multimodal:acetaminophen, gabapentin, ketamine, bupivacaine

acetaminophen, gabapentin, ketamine, bupivacaine and standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane

Intervention Type: DRUG

placebo pills and injectables

receives standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane plus placebos of intervention arm meds

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• American Society of Anesthesiologists (ASA) physical status 1-3
• BMI of < 40 kg/m2
• Consents to general anesthesia and pre-operative femoral nerve block for case

Exclusion Criteria

• Any contraindication to a femoral nerve block
• Allergy to local anesthetics, nonsteroidal anti-inflammatory medications, ketamine, acetaminophen, hydromorphone, oxycodone
• Peripheral or central nervous system disease
• Renal or hepatic impairment
• History of opioid dependence or current regular narcotic use
• Significant psychiatric disease
• Pregnancy or lactation (by verbal report)
• Seizure Disorder
• History of post-operative nausea and vomiting
• Latex allergy
• Clinically significant cardiac or pulmonary disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John A Shepler

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin

Madison, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2017-0712

Identifier Type: OTHER

Identifier Source: secondary_id

A530900

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/ANESTHESIOLOGY

Identifier Type: OTHER

Identifier Source: secondary_id

2012-0538

Identifier Type: -

Identifier Source: org_study_id