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

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

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.

Study Overview

• Status: Unknown
• Conditions: Total Knee Arthroplasty; Adductor Canal Block; Sciatic Nerve Block
• Intervention / Treatment: Device: Ultrasound; Drug: bupivacaine and lidocaine; Drug: bupivacaine and dexamethasone

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Bangkoknoi, Bangkok, Thailand, 10700
      • Siriraj Hospital, Mahidol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
SHAM_COMPARATOR: control group; adductor canal block with sham block	Device: Ultrasound; ultrasound; Drug: 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
EXPERIMENTAL: sciatic group; adductor canal block with popliteal sciatic nerve block	Device: Ultrasound; ultrasound; 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; Other Names: bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain score at rest	postoperative pain score at rest at 24 hour	postoperative 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
level of tibialis anterior muscle weakness	level of tibialis anterior muscle weakness in 24 hour	postoperative 24 hours
adverse events	perioperative adverse events such as LAST, hypotension, nausea and vomitting	postoperative 24 hours
total morphine consumption in postoperative 24 hours	total morphine consumption in postoperative 24 hours	postoperative 24 hours
patient satisfaction	patient satisfaction score	postoperative 24 hours
length of hospital stay	length of hospital stay	7 days

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Busara Sirivanasandha, MD, Department of Anesthesia, Siriraj hospital, Mahidol university

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2018
• Primary Completion (ANTICIPATED): February 1, 2019
• Study Completion (ANTICIPATED): February 1, 2019

Study Registration Dates

• First Submitted: March 15, 2018
• First Submitted That Met QC Criteria: April 2, 2018
• First Posted (ACTUAL): April 3, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 3, 2018
• Last Update Submitted That Met QC Criteria: April 2, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: dexamethasone; adductor canal block; popliteal sciatic nerve block; total knee artgroplasty
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Dexamethasone; Lidocaine; Bupivacaine
• Other Study ID Numbers: 768/2560(EC1)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes