ACL Repair and Multimodal Analgesia

Pain Clinical Trial

Official title:

ACL Repair and Multimodal Analgesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01868425
• Other study ID #: 2012-0538
• Secondary ID: 2017-0712A530900
• Status: Completed
• Phase: Phase 4
• Start date: April 2013
• Est. completion date: December 2017

Study information

• Verified date: March 2020
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• multimodal:acetaminophen, gabapentin, ketamine, bupivacaine
acetaminophen, gabapentin, ketamine, bupivacaine and standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane
• placebo pills and injectables
receives standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane plus placebos of intervention arm meds

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain Scores During Recovery	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.	up to 24 hours postoperatively
Secondary	Number of Participants Who Received Medication for Nausea	Number of participant who received medication for nausea prior to discharge and after discharge, up to 24 hours post-op.	Up to 24 hours following surgery
Secondary	Post-Operative Incidence of Nausea	Incidence of nausea as recorded in the electronic medical record (EMR) in the recovery room through the first 24-hrs post-op.	Up to 24 hours following surgery
Secondary	Post-Operative Nausea Scores	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).	Up to 24 hours following surgery
Secondary	Incidence of Post-Operative Pruritus	Pruritus in recovery and through the first 24 hours post-op.	Up to 24 hours following surgery
Secondary	Post-Operative Pruritis Score	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.	Up to 24 hours following surgery
Secondary	Sedation Scale	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.	Up to 24 hours following surgery
Secondary	Impact of Block Characteristics on Pain Control		Up to 24 hours following surgery
Secondary	Intraoperative Medication Use: Ketorolac and Lidocaine	All participants received standard induction medications.	From induction until arrival in post anesthesia care unit.
Secondary	Intraoperative Medication Use: Fentanyl	All participants received standard induction medications.	From induction until arrival in post anesthesia care unit.
Secondary	Number of Participants With Complications From the Procedure		Up to 24 hours following surgery
Secondary	Time to Discharge	Time to discharge from the recovery room (Phase I recovery) and the outpatient surgery center (Phase II recovery).	Up to 24 hours following surgery