Clinical trial NCT03486548: Analgesic Efficacy of Adding SCB With Low Concentration Bupivacaine Combined With Dexamethasone on Pain After TKA
Official title: Analgesic Efficacy of Adding SCB With Low Concentration Bupivacaine Combined With Dexamethasone to ACB and Periarticular Injection on Postoperative Pain After TKA: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Total Knee Arthroplasty
Adductor Canal Block
Sciatic Nerve Block
Keywords: popliteal sciatic nerve block
total knee artgroplasty
adductor canal block
dexamethasone
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2018-04-03
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluate the efficacy of adding popliteal sciatic nerve block with low concentration bupivacaine and dexamethasone to abductor canal block for total knee arthroplasty in patient with NSAIDs prescribing precaution. Half of participants will receive popliteal sciatic nerve block, abductor canal block and periarticular injection, while the other half will receive a sham block, abductor canal block and periarticular injection.

Detailed description: After informed and consent, all patients will be devided into two groups, Sciatic group (group S) and Controlled group (group C). All patients will receive adductor canal block, then patients in group S will receive Sciatic nerve block with low concentration bupivacaine and dexamethasone while partients in group C will receive sham block. All patient will receive spinal anesthesia and intraoperative periarticular injection.

Postoperative pain score, muscle strength, total morphine consumption and adverse events will be record in case record form.

Eligibility criteria: Inclusion Criteria:

* patient scheduled for single total knee arthroplasty
* patient with NSAIDs prescribing precautions such as history of NSAIDs allergy, Chronic kidney disease (GFR\< 50 ml/min), history of ischemic heart disease or cerebrovascular disease

Exclusion Criteria:

* patient refusal
* body weight less than 45 kg
* history of allergy to bupivacaine or dexamethasone
* uncontrolled diabetes mellitus
* contraindicated for spinal block, adductor canal block or sciatic nerve block
* inability to assess pain score (cognitive or psychiatric history)
* patient scheduled for revision TKA
* preexisting neuropathy or neurological deficit in lower extremity
* preexisting chronic pain (prolonged use of oral morphine 20 mg/day or equivalent)

Primary outcomes:
measure: postoperative pain score at rest
timeFrame: postoperative 24 hours
Secondary outcomes:
measure: postoperative pain score at anterior and posterior site of knee
timeFrame: postoperative 24 hours
measure: postoperative pain score on 45 degree knee flexion and physical therapy
timeFrame: postoperative 24 hours
measure: level of tibialis anterior muscle weakness
timeFrame: postoperative 24 hours
measure: adverse events
timeFrame: postoperative 24 hours
measure: total morphine consumption in postoperative 24 hours
timeFrame: postoperative 24 hours
measure: patient satisfaction
timeFrame: postoperative 24 hours
measure: length of hospital stay
timeFrame: 7 days
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Siriraj Hospital, Mahidol University
state: Bangkok
Study officials:
affiliation: Department of Anesthesia, Siriraj hospital, Mahidol university
name: Busara Sirivanasandha, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sirivanasandha B, Sutthivaiyakit K, Kerdchan T, Poolsuppasit S, Tangwiwat S, Halilamien P. Adding a low-concentration sciatic nerve block to total knee arthroplasty in patients susceptible to the adverse effects of non-steroidal anti-inflammatory drugs (NSAIDs): a randomized controlled trial. BMC Anesthesiol. 2021 Nov 13;21(1):282. doi: 10.1186/s12871-021-01491-7.