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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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230724009
Enrollment
56
Registered
2023-07-24
Start date
2023-07-26
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Using 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

Interventions

ISB protocol The standard monitoring, such as electrocardiogram (EKG), non-invasive blood pressure (NIBP) and pulse oximeter will be attached to the patient and monitored during the ISB procedure. An
Active Comparator Procedure/Surgery,Experimental Procedure/Surgery
Interscalene block (ISB),Local injection analgesia (LIA)

Sponsors

Research Affairs, Faculty of Medicine, Khon Kaen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Posoperative pain at rest At 24 hours postoperatively VAS pain score

Secondary

MeasureTime frame
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

Countries

Thailand

Contacts

Public ContactThawathit Thangtamniyom

Faculty of Medicine, Khon Kaen University

thawath@kku.ac.th0909792704

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026