Lee 2013.
| Methods | Single‐blinded (outcome assessor) clinical RCT Sequence generation using random numbers table Follow‐up: 3 months |
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| Participants | Participants: 51 adults in a university setting in Cork, Ireland Operation: breast surgery (mastectomy or breast tumour resection) with axillary node clearance 2 groups, size: 26/25 Age, years (± SD), group 1, 2 : 57.8 (± 14.5), 54.3 (± 11.5) Men/women: all women Comorbidities: wide local excision/mastectomy/mastectomy and reconstruction, n (group 1, 2): 16/9/1, 13/11/1. Chemotherapy, n (group 1, 2): 13, 18. Further surgery, n: None/wide local excision/mastectomy/wide local excision and mastectomy (group 1, 2): 18/4/1/3, 18/3/2/2. Remarks: exclusion criteria included pre‐existing pain conditions other than those due to breast lump biopsy |
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| Interventions |
Group 1 (Group C, control): as needed morphine IV intro. Post‐op morphine 2 mg IV as needed in PACU until morphine PCA x 48 h post‐op (2 mg bolus, 5 min lockout, no background, max dose 30 mg 4 h), diclofenac 50 mg oral/PR every 8 h as needed, paracetamol 1 g oral/PR/IV every 6 h as needed Group 2 (Group P, paracetamol and paravertebral): paravertebral catheter inserted prior to induction, 10 mL bupivacaine 0.25% injected with repeat aspiration tests then catheter inserted. 10 mL bupivacaine 0.25% 4 h post‐op then every 12 h x 48 h Both groups: GA induction with propofol 2‐2.5 mg/kg, maintenance with sevoflurane in O2/N2O mixture, vecuronium with 75 mg IV diclofenac sodium and 1 g IV paracetamol intraoperatively. All participants received 100 mg tramadol oral as rescue if required. Adjuvants: pregabalin Immediate post‐op pain control: not significantly improved, but with significantly decreased analgesic consumption |
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| Outcomes | Dichotomous: pain/no pain at 3 months Continuous: Short‐form McGill Pain questionnaire at 3 months Secondary: Hospital Anxiety and Depression score, Spielberger Tate‐Trait Anxiety Inventory at 3 months, allodynia/hyperalgesia |
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| Notes | Funding sources: "PL received a research grant from the South of Ireland Association of Anaesthetists." Conflicts of interest: "nothing to declare" |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "using a random numbers table, patients were randomly allocated to one of two groups" |
| Allocation concealment (selection bias) | Low risk | Upon contacting study author: quote: "these pieces of paper were then placed in opaque sealed numbered envelopes" |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Upon contacting study author: quote: "the envelopes were not opened until all study information was gathered and data analysis had begun" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "patients were interviewed three months postoperatively...by an investigator blinded to their group assignment" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No participants were lost to follow‐up. ITT analysis performed |
| Selective reporting (reporting bias) | Low risk | All expected outcomes were reported on. |
| Null bias | High risk | Quote: "patients in the two groups were similar in terms of reported pain intensity in the early postoperative period," |