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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05727137
• Other study ID #: H-2209-136-1362
• Status: Completed
• Phase: N/A
• Start date: February 21, 2023
• Est. completion date: March 8, 2024

Study information

• Verified date: April 2024
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 8, 2024
• Est. primary completion date: October 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Single shot adductor canal block
Single shot adductor canal block on the the first and second postoperative day.
• Continuous adductor canal block
A catheter will be placed in the adductor canal and connected to a continuous patient-controlled analgesia pump.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Seoul National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	NRS pain score at rest at +8h from end of surgery		+8h from end of surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	NRS pain score at rest at 2PM on postoperative day 1		2PM on postoperative day 1
Secondary	NRS pain score during movement at 2PM on postoperative day 1		2PM on postoperative day 1
Secondary	NRS pain score at rest at 10PM on postoperative day 1		10PM on postoperative day 1
Secondary	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
Secondary	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
Secondary	NRS pain score during movement at 6AM on postoperative day 2		6AM on postoperative day 2
Secondary	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
Secondary	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
Secondary	Posteoperative opioid administration in morphine equivalents		from end of surgery to 48h after surgery
Secondary	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
Secondary	Incidence of extravasation from catheter insertion site		at 2PM on postoperative day 1 and 2
Secondary	Incidence of sleep disturbance due to pain		from end of surgery to postoperative day 2
Secondary	Incidence of numbness of anterior thigh area		at 2PM on postoperative day 1 and 2
Secondary	Strengh of quadratus femoris muscle (unit: kgf)		at 2PM on postoperative day 1 and 2
Secondary	Incidence of falls during hospital stay		from end of surgery to 48h after surgery
Secondary	Postoperative range of motion of knee joint		at 2PM on postoperative day 1 and 2