Clinical trial NCT01868425: ACL Repair and Multimodal Analgesia
Official title: ACL Repair and Multimodal Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2013-06-04
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Opioid Consumption in the Immediate Postoperative Period
timeFrame: Up to 10 hours
Secondary outcomes:
measure: Pain Scores During Recovery
timeFrame: up to 24 hours postoperatively
measure: Number of Participants Who Received Medication for Nausea
timeFrame: Up to 24 hours following surgery
measure: Post-Operative Incidence of Nausea
timeFrame: Up to 24 hours following surgery
measure: Post-Operative Nausea Scores
timeFrame: Up to 24 hours following surgery
measure: Incidence of Post-Operative Pruritus
timeFrame: Up to 24 hours following surgery
measure: Post-Operative Pruritis Score
timeFrame: Up to 24 hours following surgery
measure: Sedation Scale
timeFrame: Up to 24 hours following surgery
measure: Impact of Block Characteristics on Pain Control
timeFrame: Up to 24 hours following surgery
measure: Intraoperative Medication Use: Ketorolac and Lidocaine
timeFrame: From induction until arrival in post anesthesia care unit.
measure: Intraoperative Medication Use: Fentanyl
timeFrame: From induction until arrival in post anesthesia care unit.
measure: Number of Participants With Complications From the Procedure
timeFrame: Up to 24 hours following surgery
measure: Time to Discharge
timeFrame: Up to 24 hours following surgery
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: John A Shepler
role: PRINCIPAL_INVESTIGATOR
References: