Clinical trial NCT05727137: Daily Single Shot Adductor Canal Block Versus Continuous Adductor Canal Block After Total Knee Arthroplasty
Official title: Analgesic Efficacy of Daily Single Shot Adductor Canal Block Versus Continuous Adductor Canal Block After Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University
First posted: 2023-02-14
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Average NRS pain score at rest
timeFrame: first 48h after end of surgery
Secondary outcomes:
measure: numerical rating scale (0: no pain, 10: worst imaginable pain) pain score at rest at +4h from end of surgery
timeFrame: +4h from end of surgery
measure: numerical rating scale (0: no pain, 10: worst imaginable pain) pain score during movement at +4h from end of surgery
timeFrame: +4h from end of surgery
measure: NRS pain score at rest at +8h from end of surgery
timeFrame: +8h from end of surgery
measure: numerical rating scale (0: no pain, 10: worst imaginable pain) pain score during movement at +8h from end of surgery
timeFrame: +8h from end of surgery
measure: numerical rating scale (0: no pain, 10: worst imaginable pain) pain score at rest at +12h from end of surgery
timeFrame: +12h from end of surgery
measure: numerical rating scale (0: no pain, 10: worst imaginable pain) pain score during movement at +12h from end of surgery
timeFrame: +12h from end of surgery
measure: numerical rating scale (0: no pain, 10: worst imaginable pain) pain score at rest at 6AM on postoperative day 1
timeFrame: 6AM on postoperative day 1
measure: numerical rating scale (0: no pain, 10: worst imaginable pain) pain score during movement at 6AM on postoperative day 1
timeFrame: 6AM on postoperative day 1
measure: NRS pain score at rest at 2PM on postoperative day 1
timeFrame: 2PM on postoperative day 1
measure: NRS pain score during movement at 2PM on postoperative day 1
timeFrame: 2PM on postoperative day 1
measure: NRS pain score at rest at 10PM on postoperative day 1
timeFrame: 10PM on postoperative day 1
measure: numerical rating scale (0: no pain, 10: worst imaginable pain) pain score during movement at 10PM on postoperative day 1
timeFrame: 10PM on postoperative day 1
measure: numerical rating scale (0: no pain, 10: worst imaginable pain) pain score at rest at 6AM on postoperative day 2
timeFrame: 6AM on postoperative day 2
measure: NRS pain score during movement at 6AM on postoperative day 2
timeFrame: 6AM on postoperative day 2
measure: numerical rating scale (0: no pain, 10: worst imaginable pain) pain score at rest at 2PM on postoperative day 2
timeFrame: 2PM on postoperative day 2
measure: numerical rating scale (0: no pain, 10: worst imaginable pain) pain score during movement at 2PM on postoperative day 2
timeFrame: 2PM on postoperative day 2
measure: Posteoperative opioid administration in morphine equivalents
timeFrame: from end of surgery to 48h after surgery
measure: Incidence of catheter tip dislocation
timeFrame: at 2PM on postoperative day 1 and 2
measure: Incidence of extravasation from catheter insertion site
timeFrame: at 2PM on postoperative day 1 and 2
measure: Incidence of sleep disturbance due to pain
timeFrame: from end of surgery to postoperative day 2
measure: Incidence of numbness of anterior thigh area
timeFrame: at 2PM on postoperative day 1 and 2
measure: Strengh of quadratus femoris muscle (unit: kgf)
timeFrame: at 2PM on postoperative day 1 and 2
measure: Incidence of falls during hospital stay
timeFrame: from end of surgery to 48h after surgery
measure: Postoperative range of motion of knee joint
timeFrame: at 2PM on postoperative day 1 and 2
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Seokha Yoo, MD
role: PRINCIPAL_INVESTIGATOR
References: