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Efficacy of local infiltration anesthesia versus interscalene brachial plexus block for postoperative pain controlled after arthroscopic rotator cuff surgery: A non-inferiority trial

Phase 2
Conditions
sing local injection analgesia (LIA) might be non-inferior to interscalene block (ISB) for postoperative pain control in our arthroscopic rotator cuff surgery.
Local infiltration analgesia, interscalene block, arthroscopic rotator cuff surgery, pain, opioid
Registration Number
TCTR20230724009
Lead Sponsor
Research Affairs, Faculty of Medicine, Khon Kaen University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending (Not yet recruiting)
Sex
All
Target Recruitment
56
Inclusion Criteria

1. The patients who are required for arthroscopic rotator cuff surgery; which are including arthroscopic examination, rotator interval release, subacromial decompression, limited acromioplasty, arthroscopic rotator repair or debridement for routine and consider performing biceps tenotomy or tenodesis if the patients have biceps tendon lesion
2. Aged over 18 years old
3. American Society of Anesthesiologists (ASA) physical state I-III

Exclusion Criteria

1. Taking opioids for more than 1 month before surgery (chronic opioid used)
2. Pre-existing neuropathy at the affected limb
3. History of previous surgery of ipsilateral shoulder
4. Allergy to study drugs; bupivacaine, adrenaline, ketorolac, TXA, opioids, NSAIDs or paracetamol
5. Contraindication to ISB; COPD, skin disease, contralateral lung pathology
6. Infection at the site of application
7. Bleeding diathesis; coagulopathy, thrombocytopenia
8. Inability to understand how to report pain scores
9. Inability to understand how to use intravenous PCA

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Posoperative pain at rest At 24 hours postoperatively VAS pain score
Secondary Outcome Measures
NameTimeMethod
Morphine consumption At 1, 6, 12, 24 and 48 hours postoperatively and before discharge Recorded from IV PCA,Satisfication At discharge date Satisfication score,Posoperative pain at rest At 1, 6, 12 and 48 hours postoperatively and before discharge VAS pain score,Posoperative pain at motion (neutral rotation and shoulder elevation in scapular plane; not exceed 90 degrees) At 24 and 48 hours postoperatively and before discharge VAS pain score,Opioids related complications From immediate postoperative time until discharge date Sedation score, PONV score, Itching, Respiratory rate ,ISB and LIA related complications From immediate postoperative time until discharge date LAST, PNI ,Operative complications From immediate postoperative time until discharge date Any events related to the operation
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