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

Not Applicable

Completed

• Conditions: Postoperative Pain

• Registration Number: NCT05727137
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-01-25
• Study First Submitted QC: 2023-02-03
• Study First Posted: 2023-02-14
• Study Start: 2023-02-21
• Primary Completion: 2023-10-27
• Study Completion: 2024-03-08
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Average NRS pain score at rest	first 48h after end of surgery	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)

Secondary Outcome Measures

Name	Time	Method
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
Incidence of falls during hospital stay	from end of surgery to 48h after 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 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 during movement at 2PM on postoperative day 2	2PM on postoperative day 2
Postoperative range of motion of knee joint	at 2PM on postoperative day 1 and 2
NRS pain score during movement at 2PM on postoperative day 1	2PM 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
Posteoperative opioid administration in morphine equivalents	from end of surgery to 48h after surgery
Incidence of catheter tip dislocation	at 2PM on postoperative day 1 and 2	The catheter tip is considered to be dislocated if the catheter tip is located outside the adductor canal
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of