Daily Single Shot Adductor Canal Block Versus Continuous Adductor Canal Block After Total Knee Arthroplasty

Analgesic Efficacy of Daily Single Shot Adductor Canal Block Versus Continuous Adductor Canal Block After Total Knee Arthroplasty

This study will compare the analgesic efficacy of daily single-shot adductor canal block(ABC) versus continuous ACB after total knee arthroplasty (TKA).

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: Single shot adductor canal block; Procedure: Continuous adductor canal block

Detailed Description

Patients 19-75 years old, of ASA classification I-III scheduled for unilateral TKA, will be enrolled and randomized into two groups, single-shot ACB group and continuous ACB group. In both groups, participants will be administered a single-shot ACB immediately after the end of the operation. The single-shot ACB group will receive two separate single-shot ACBs, on the first and second postoperative day. A nerve block catheter will be placed in patients in the continuous ACB group, which will be connected to a patient-controlled analgesia pump until the second postoperative day. The primary outcome of this study is the average NRS pain score at rest from the end of surgery to 2 days after surgery.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• ASA classification I, II, III
• Patients scheduled for unilateral knee arthroplasty

Exclusion Criteria:

• Anesthesia other than spinal anesthesia
• Chronic opioid use
• Uncontrolled diabetes of HbA1c>7.5
• Neuromuscular pathology of the ipsilateral leg
• Second-look knee arthroplasty
• Inability to communicate (e.g. dementia)
• Hypersensitivity to ropivacaine
• BMI > 40
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single shot adductor canal block	Procedure: Single shot adductor canal block; Single shot adductor canal block on the the first and second postoperative day.
Active Comparator: Continuous adductor canal block	Procedure: Continuous adductor canal block; A catheter will be placed in the adductor canal and connected to a continuous patient-controlled analgesia pump.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average NRS pain score at rest	average of numerical rating scale (0: no pain, 10: worst imaginable pain) pain scores from 8 time points during 48h (+4h, +8h, +12h from end of surgery, 6AM, 2PM, 10PM of postoperative day 1, and 6AM and 2PM of postoperative day 2)	first 48h after end of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
numerical rating scale (0: no pain, 10: worst imaginable pain) pain score at rest at +4h from end of surgery		+4h from end of surgery
numerical rating scale (0: no pain, 10: worst imaginable pain) pain score during movement at +4h from end of surgery		+4h from end of surgery
NRS pain score at rest at +8h from end of surgery		+8h from end of surgery
numerical rating scale (0: no pain, 10: worst imaginable pain) pain score during movement at +8h from end of surgery		+8h from end of surgery
numerical rating scale (0: no pain, 10: worst imaginable pain) pain score at rest at +12h from end of surgery		+12h from end of surgery
numerical rating scale (0: no pain, 10: worst imaginable pain) pain score during movement at +12h from end of surgery		+12h from end of surgery
numerical rating scale (0: no pain, 10: worst imaginable pain) pain score at rest at 6AM on postoperative day 1		6AM on postoperative day 1
numerical rating scale (0: no pain, 10: worst imaginable pain) pain score during movement at 6AM on postoperative day 1		6AM on postoperative day 1
NRS pain score at rest at 2PM on postoperative day 1		2PM on postoperative day 1
NRS pain score during movement at 2PM on postoperative day 1		2PM on postoperative day 1
NRS pain score at rest at 10PM on postoperative day 1		10PM on postoperative day 1
numerical rating scale (0: no pain, 10: worst imaginable pain) pain score during movement at 10PM on postoperative day 1		10PM on postoperative day 1
numerical rating scale (0: no pain, 10: worst imaginable pain) pain score at rest at 6AM on postoperative day 2		6AM on postoperative day 2
NRS pain score during movement at 6AM on postoperative day 2		6AM on postoperative day 2
numerical rating scale (0: no pain, 10: worst imaginable pain) pain score at rest at 2PM on postoperative day 2		2PM on postoperative day 2
numerical rating scale (0: no pain, 10: worst imaginable pain) pain score during movement at 2PM on postoperative day 2		2PM on postoperative day 2
Posteoperative opioid administration in morphine equivalents		from end of surgery to 48h after surgery
Incidence of catheter tip dislocation	The catheter tip is considered to be dislocated if the catheter tip is located outside the adductor canal	at 2PM on postoperative day 1 and 2
Incidence of extravasation from catheter insertion site		at 2PM on postoperative day 1 and 2
Incidence of sleep disturbance due to pain		from end of surgery to postoperative day 2
Incidence of numbness of anterior thigh area		at 2PM on postoperative day 1 and 2
Strengh of quadratus femoris muscle (unit: kgf)		at 2PM on postoperative day 1 and 2
Incidence of falls during hospital stay		from end of surgery to 48h after surgery
Postoperative range of motion of knee joint		at 2PM on postoperative day 1 and 2

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Seoul National University
• Investigators: Principal Investigator: Seokha Yoo, MD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2023
• Primary Completion (Actual): October 27, 2023
• Study Completion (Actual): March 8, 2024

Study Registration Dates

• First Submitted: January 25, 2023
• First Submitted That Met QC Criteria: February 3, 2023
• First Posted (Actual): February 14, 2023

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: H-2209-136-1362

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No