ACL Repair and Multimodal Analgesia

NCT01868425 | Completed Phase 4 Results DMC FDA Drug

• 4 other identifiers: 2012-05382017-0712A530900SMPH/ANESTHESIOLOGY
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Opioid Consumption in the Immediate Postoperative Period

  This data will be entered into the participants electronic medical record and collected from their chart once the participant has been discharged. The "immediate postoperative period" covers the participant's entire time in the outpatient surgery center after they have entered the recovery room postoperatively. The amount of time they remain in the outpatient surgery center postoperatively varies from a minimum of 1 hour to a maximum of 10 hours and an average of 4 hours.

  Up to 10 hours

Secondary Outcomes (12)

• Pain Scores During Recovery

  up to 24 hours postoperatively

• Number of Participants Who Received Medication for Nausea

  Up to 24 hours following surgery

• Post-Operative Incidence of Nausea

  Up to 24 hours following surgery

• Post-Operative Nausea Scores

  Up to 24 hours following surgery

• Incidence of Post-Operative Pruritus

  Up to 24 hours following surgery

Study Arms (2)

multimodal:acetaminophen, gabapentin, ketamine, bupivacaine

EXPERIMENTAL

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

Drug: multimodal:acetaminophen, gabapentin, ketamine, bupivacaine

placebo pills and injectables

PLACEBO COMPARATOR

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

Drug: placebo pills and injectables

Interventions

multimodal:acetaminophen, gabapentin, ketamine, bupivacaine DRUG

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

multimodal:acetaminophen, gabapentin, ketamine, bupivacaine

placebo pills and injectables DRUG

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

placebo pills and injectables

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Gabapentin; Ketamine; Bupivacaine; Injections

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Anilides; Amides; Aniline Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: John Shepler
• Organization: University of Wisconsin - Madison

jashepler@wisc.edu

608-263-8100

Study Officials

• John A Shepler

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: May 13, 2013
• First Posted: June 4, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 30, 2020
• Results First Posted: March 16, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)