Continuous Distal Adductor Canal Block With Periarticular Local Anesthetic Infiltration Versus Continuous Distal Adductor Canal Block Alone for Analgesia After Total Knee Arthroplasty

• Sponsor: Yonsei University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05427019
• Collaborator: (none)
• Enrollment: 66
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 21.5
• Patients Per Site Per Month: 3.1

Study Details

Study Description

Brief Summary

Continuous administration of local anesthetics to the distal adductor canal could spread into the popliteal fossa and contribute to analgesic effects on posterior knee pain. Periarticular local anesthetic infiltration is a component of multimodal joint pathways and the posterior knee capsule was among the tissues routinely infiltrated. It is expected that there will be overlapping effects of distal adductor canal block and periarticular injection. Therefore, we aim to compare the postoperative pain in the group that received only continuous distal adductor canal block and the group that received both continuous distal adductor canal block and periarticular injection. Sixty-six patients scheduled for total knee arthroplasty will be randomly divided into the two groups. In group 1, the adductor canal catheter is inserted 2cm above the adductor hiatus. In group 2, the adductor canal catheter is inserted where the nerve block performed in group 1 and periarticular injection are performed intraoperatively.

Condition or Disease	Intervention/Treatment	Phase
Degenerative Osteoarthritis	Procedure: Distal adductor canal block; Procedure: Distal adductor canal block and Periarticular block	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Continuous Distal Adductor Canal Block With Periarticular Local Anesthetic Infiltration Versus Continuous Distal Adductor Canal Block Alone for Analgesia After Total Knee Arthroplasty
• Actual Study Start Date: Jul 17, 2022
• Anticipated Primary Completion Date: May 1, 2024
• Anticipated Study Completion Date: May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Distal adductor canal block Participants receiving continuous distal adductor canal block	Procedure: Distal adductor canal block; All catheters were inserted under a full aseptic technique using a real-time ultrasound-guided in-plane approach by an experienced anesthesiologist. The adductor canal catheter is inserted 2cm above the adductor hiatus.
Active Comparator: Distal adductor canal block and Periarticular block Participants receiving continuous distal adductor canal block and periarticular block	Procedure: Distal adductor canal block and Periarticular block; All catheters were inserted under a full aseptic technique using a real-time ultrasound-guided in-plane approach by an experienced anesthesiologist. The adductor canal catheter is inserted 2cm above the adductor hiatus.The periarticular injection solution contained 20mL of 7.5 mg/mL ropivacaine, 30mg of ketorolac, and 0.3mL of 1.0 mg/mL epinephrine. These agents were mixed with normal saline to a combined volume of 50mL. The surgeon injected this mixture into the tensor fascia lata, subcutaneous tissues, abductors, short external rotators muscles, and structures in the capsule.

Outcome Measures

Primary Outcome Measures

1. Numeric rating scale pain score [at 24 hours postoperatively]

   Pain intensity at rest evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain) at 24 hours postoperatively

Secondary Outcome Measures

1. pain score at the other time points and Quadriceps muscle strength [Pain score measured at 36 hours postoperatively and 48h postoperatively Quadriceps muscle strength measured at 24 hours postoperatively]

   Pain intensity at rest evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain) at 36 hours postoperatively and 48h postoperatively Quadriceps muscle strength will be measured by the dynamometer at 24h postoperatively

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients aged 19 years old or older, with American Society of Anesthesiologists Physical Status 1-3, and scheduled for elective unilateral total knee arthroplasty

Exclusion Criteria:

1. Allergy or intolerance to any of the drugs used in the study 2. Hepatic or renal insufficiency 3. Opioid dependency 4. Coagulopathy 5. Pre-existing neurologic or anatomic deficits in the lower extremities 6. Severe psychiatric illness

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yonsei University Health System, Severance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Yonsei University

Investigators

• Principal Investigator: Yong Seon Choi, Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT05427019
• Other Study ID Numbers: 4-2022-0508
• First Posted: Jun 22, 2022
• Last Update Posted: Aug 10, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Osteoarthritis

Study Results

No Results Posted as of Aug 10, 2022