Comparing Ropivacaine Adductor Canal Blockade by Surgeon Versus Anesthesiologist

Pain, Postoperative Clinical Trial

Official title:

A Randomized Controlled Trial Comparing Intraoperative Surgeon-Performed Versus Anesthesiologist-Performed Adductor Canal Blockade After Primary Total Knee Arthroplasty

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03864588
• Other study ID #: 2018LonnerSS
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: October 1, 2018
• Est. completion date: September 2019

Study information

• Verified date: March 2019
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of two methods of administering an adductor canal block (ACB) following total knee arthroplasty (TKA); intraoperative surgeon performed intra-articular adductor canal block (IACB) and anesthesiologist ultrasound guided ADC in the post-anesthesia recovery unit (PACU).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 164
• Est. completion date: September 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients undergoing unilateral primary TKA with underlying diagnosis of osteoarthritis

• ASA I - III

• Spinal anesthesia

• All patients will have cemented total knee utilizing a medial parapatellar approach with posterior stabilized or cruciate retaining implants. A tourniquet will be used in all cases.

• Patients must be between 18 and 80 years of age.

• Active and valid email address for the participant.

Exclusion Criteria:

• Allergy to anesthetics or study analgesic medications.

• Contraindication to regional anesthesia

• Non-english speaking

• ASA IV or greater

• Renal insufficiency with Cr > 2.0 or hepatic failure

• General or epidural anesthesia

• Sensory/motor disorder involving the operative limb

• Patients who consume preoperative opioids for pain control.

• Pregnant women

• Mentally disabled patients and patients with psychiatric disorders that would prevent them from properly understanding and evaluating an informed consent process.

• Prisoners

Related Conditions & MeSH terms

• Pain, Postoperative
• Satisfaction

Intervention

Drug:
• Ropivacaine
For primary TKA, Ropivacaine is used in both arms, either performed intra-operatively by surgeon or post-operatively (ultrasound guided) by anesthesiologist.

Locations

Country	Name	City	State
United States	Rothman Institute	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics	Sharpe-Strumia Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in visual analog scale pain score	The primary end point is the patients' reported visual analogue pain score (VAS). 0-100mm scale	Up to 6 weeks post-surgery
Secondary	Change in range of motion	Range of motion	up to 6 weeks post-surgery
Secondary	Change in timed up and go	Timed up and go	up to 6 weeks post-surgery
Secondary	Change in daily opioid consumption	daily opioid consumption	up to 6 weeks post-surgery