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Completed

NCT Number: NCT01868425

ACL Repair and Multimodal Analgesia

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.

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Wisconsin

Madison, Wisconsin, 53705, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of orthopedic surgeons on the study team scheduled for ACL repair using hamstring graft from the same leg will be considered for inclusion in this study. Other inclusion criteria are as follows:
  • 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

Treatment and study plan

multimodal:acetaminophen, gabapentin, ketamine, bupivacaine

Drug

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

placebo pills and injectables

Drug

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

Primary outcomes

  1. Opioid Consumption in the Immediate Postoperative Period

    Time frame: Up to 10 hours

    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.

Secondary outcomes

  1. Pain Scores During Recovery

    Time frame: up to 24 hours postoperatively

    Pain scores during recovery period through the first 24 hours of recovery, recorded upon arrival to recovery room, 1-hr post-op, 24-hrs post-op. This outcome reports lowest and highest pain score since discharge to 24 hour phone call. Pain scores are collected verbally on a scale of 0-10 where 10 is the most severe pain.

  2. Number of Participants Who Received Medication for Nausea

    Time frame: Up to 24 hours following surgery

    Number of participant who received medication for nausea prior to discharge and after discharge, up to 24 hours post-op.

  3. Post-Operative Incidence of Nausea

    Time frame: Up to 24 hours following surgery

    Incidence of nausea as recorded in the electronic medical record (EMR) in the recovery room through the first 24-hrs post-op.

  4. Post-Operative Nausea Scores

    Time frame: Up to 24 hours following surgery

    Nausea scores will be collected in post-operative recovery and 24 hours later (via phone). The participant will be asked to rate their nausea on a scale of 0 (no nausea) - 10 (worst possible).

  5. Incidence of Post-Operative Pruritus

    Time frame: Up to 24 hours following surgery

    Pruritus in recovery and through the first 24 hours post-op.

  6. Post-Operative Pruritis Score

    Time frame: Up to 24 hours following surgery

    Participants will be asked to rate their pruritis on a scale of 0 (no itching) - 10 (worst itchiness) while in post-op recovery room and then at 24 hours post-op via phone call.

  7. Sedation Scale

    Time frame: Up to 24 hours following surgery

    Sedation scale measured in recovery room, 1-hr post op, and 24 hrs op. The Sedation Scale is scored from 0-10 where 0 = normal, no sleepier than average, 10 = sleepy, hard to stay awake.

  8. Impact of Block Characteristics on Pain Control

    Time frame: Up to 24 hours following surgery

  9. Intraoperative Medication Use: Ketorolac and Lidocaine

    Time frame: From induction until arrival in post anesthesia care unit.

    All participants received standard induction medications.

  10. Intraoperative Medication Use: Fentanyl

    Time frame: From induction until arrival in post anesthesia care unit.

    All participants received standard induction medications.

  11. Number of Participants With Complications From the Procedure

    Time frame: Up to 24 hours following surgery

  12. Time to Discharge

    Time frame: Up to 24 hours following surgery

    Time to discharge from the recovery room (Phase I recovery) and the outpatient surgery center (Phase II recovery).

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jun 4, 2013
Registry last updated
Mar 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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