Tecirli 2014.
Methods | Double‐blinded (participant/outcome assessor), randomized clinical trial Sequence generation not described Follow‐up: 3 months |
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Participants | Participants: 60 women in university hospital in Ankara, Turkey Operation: radical mastectomy (with axillary lymph node dissection) Groups, size: 30/30 Age: not listed All female participants Comorbidities: not listed |
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Interventions |
Group 1 (bupivacaine): intra‐op: intercostobrachial nerve was blocked with 10 cc 0.5% bupivacaine before being sectioned Group 2 (control): intra‐op: intercostobrachial nerve sectioned without blockage Adjuvants: none Immediate post‐op pain control: no difference |
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Outcomes | Continuous: VAS at 3 months Dichotomus: pain questionnaire at 3 months Other reported: analgesic consumption Adverse events: reported as none |
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Notes | Pain score ≥ 4 was accepted as pain Funding sources: no explanation of financial support Conflicts of interest: no conflict of interest statement given |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Sequence generation not explained |
Allocation concealment (selection bias) | Unclear risk | Concealment of allocation not explained |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Blinding of medical personnel not explained |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Knowledge of outcome assessors not indicated |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants completed the follow‐up evaluation |
Selective reporting (reporting bias) | Low risk | No subgroup analysis or selective reporting was noted |
Null bias | Low risk | Quote: "this study shows that intercostobrachial nerve block is an effective method to reduce the chronic neuropathic pain development after a breast cancer surgery." |