ACL Repair and Multimodal Analgesia

University of Wisconsin (UW)

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: placebo pills and injectables; Drug: multimodal:acetaminophen, gabapentin, ketamine, bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01868425

2012-0538

SMPH/ANESTHESIOLOGY (Other Identifier)

A530900 (Other Identifier)

2017-0712 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

---

112 participants in 2 patient groups, including a placebo group

multimodal:acetaminophen, gabapentin, ketamine, bupivacaine

Experimental group

Description:

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

Treatment:

Drug: multimodal:acetaminophen, gabapentin, ketamine, bupivacaine

placebo pills and injectables

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo pills and injectables