Analgesic Efficacy of Adding SCB With Low Concentration Bupivacaine Combined With Dexamethasone on Pain After TKA

Total Knee Arthroplasty Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03486548
• Other study ID #: 768/2560(EC1)
• Status: Not yet recruiting
• Phase: Phase 4
• First received: March 15, 2018
• Last updated: April 2, 2018
• Start date: April 2018
• Est. completion date: February 2019

Study information

• Verified date: March 2018
• Source: Mahidol University
• Contact: Busara Sirivanasandha, MD
• Phone: +6624197995
• Email: busarasiri[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Adductor Canal Block
• Sciatic Nerve Block
• Total Knee Arthroplasty

Intervention

Drug:
• bupivacaine and dexamethasone
adductor canal block with 0.33% bupivacaine 15 ml with ultrasound guided popliteal sciatic block with 0.125% bupivacaine 20 ml and dexamethasone 5 mg
• bupivacaine and lidocaine
adductor canal block with 0.33% bupivacaine 15 ml with ultrasound at popliteal sciatic area and subcutaneous infiltration popliteal area with 2% lidocaine 1 ml

Device:
• Ultrasound
ultrasound

Locations

Country	Name	City	State
Thailand	Siriraj Hospital, Mahidol University	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain score at rest	postoperative pain score at rest at 24 hour	postoperative 24 hours
Secondary	postoperative pain score at anterior and posterior site of knee	postoperative pain score at anterior and posterior site of knee at 24 hour	postoperative 24 hours
Secondary	postoperative pain score on 45 degree knee flexion and physical therapy	postoperative pain score on 45 degree knee flexion and physical therapy	postoperative 24 hours
Secondary	level of tibialis anterior muscle weakness	level of tibialis anterior muscle weakness in 24 hour	postoperative 24 hours
Secondary	adverse events	perioperative adverse events such as LAST, hypotension, nausea and vomitting	postoperative 24 hours
Secondary	total morphine consumption in postoperative 24 hours	total morphine consumption in postoperative 24 hours	postoperative 24 hours
Secondary	patient satisfaction	patient satisfaction score	postoperative 24 hours
Secondary	length of hospital stay	length of hospital stay	7 days