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

NCT ID: NCT03486548

Last Updated: 2018-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-30

Study Completion Date

2019-02-28

Brief Summary

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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

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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.

Conditions

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Total Knee Arthroplasty Adductor Canal Block Sciatic Nerve Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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control group

adductor canal block with sham block

Group Type SHAM_COMPARATOR

bupivacaine and lidocaine

Intervention Type DRUG

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

Ultrasound

Intervention Type DEVICE

ultrasound

sciatic group

adductor canal block with popliteal sciatic nerve block

Group Type EXPERIMENTAL

bupivacaine and dexamethasone

Intervention Type DRUG

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

Ultrasound

Intervention Type DEVICE

ultrasound

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Ultrasound

ultrasound

Intervention Type DEVICE

Other Intervention Names

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bupivacaine

Eligibility Criteria

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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)
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Busara Sirivanasandha, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesia, Siriraj hospital, Mahidol university

Locations

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Siriraj Hospital, Mahidol University

Bangkoknoi, Bangkok, Thailand

Site Status

Countries

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Thailand

Central Contacts

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Busara Sirivanasandha, MD

Role: CONTACT

+6624197995

Facility Contacts

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Busara Sirirvanadandha, MD

Role: primary

+66851429656

References

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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.

Reference Type DERIVED
PMID: 34773995 (View on PubMed)

Other Identifiers

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768/2560(EC1)

Identifier Type: -

Identifier Source: org_study_id

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