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

NCT05427019 | Unknown DMC

• 1 other identifier: 4-2022-0508
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Degenerative Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Numeric rating scale pain score

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

  postoperative 1 day morning (08:00-09:00 AM)

Secondary Outcomes (1)

• Numeric rating scale pain score

  postoperative 6 hours, postoperative 1 day afternoon (4:00-5:00 PM), postoperative 2 day morning (08:00-09:00 AM)

Study Arms (2)

Distal adductor canal block

ACTIVE COMPARATOR

Participants receiving continuous distal adductor canal block

Procedure: Distal adductor canal block

Distal adductor canal block and Periarticular block

ACTIVE COMPARATOR

Participants receiving continuous distal adductor canal block and periarticular block

Procedure: Distal adductor canal block and Periarticular block

Interventions

Distal adductor canal block PROCEDURE

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.

Distal adductor canal block

Distal adductor canal block and Periarticular block PROCEDURE

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.

Distal adductor canal block and Periarticular block

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Joint Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Study Officials

• Yong Seon Choi

  Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong Seon Choi

CONTACT

82-2-2224-3919; yschoi@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 22, 2022
• Study Start: July 17, 2022
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)