Wodlin 2011.
| Methods | Single‐blinded (outcome assessor), clinical RCT Sequence generation using computer‐generated block randomization table Follow‐up: 6 months |
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| Participants | Participants: 162 women aged 18‐60 from five hospitals in Sweden Operation: abdominal subtotal or total hysterectomy (for benign gynaecological disorders) 2 groups, size: 80/82 Age (range), groups 1, 2: 45 (33‐58), 46 (35‐58) All female participants Exclusion criteria: former or concomitant bilateral oophorectomy, postmenopausal without hormone therapy, gynaecological malignancy (cervical dysplasia not included) Comorbidities: indication of hysterectomy, group 1, 2: bleeding disturbances: 46, 46, mechanical symptoms: 27, 29, cervical dysplasia or endometrial hyperplasia: 4, 5, endometriosis or dysmenorrhoea: 3, 2. Total abdominal hysterectomy, group 1, 2: 55/51. Subtotal abdominal hysterectomy, group 1, 2: 25, 31. Mode of skin incision, group 1, 2: midline: 6, 7, low transverse 74, 75 |
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| Interventions |
Group 1 (GA): GA with propofol, fentanyl, rocuronium. 5 mg IV morphine administered 20 min before surgery complete Group 2 (SA): at L3/4 or L2/3 intervertebral space, 20 mg hyperbaric bupivacaine (5 mg/mL) and 0.2 mg morphine (0.4 mg/mL) administered. 15 min later, confirmed neural blockade with cold test. Sedation throughout operation with continuous IV propofol Both groups, 2 g oral paracetamol 1 h preoperatively. Surgeon injected 40 mL bupivacaine (2.5 mg/mL) SC and pre‐fascially in abdominal wall before end of surgery. Postoperatively, oral paracetamol and diclofenac scheduled 3 x day during hospitalization. Oral or IV opioids given if necessary. Rescue antiemetic with droperidol, then 5‐HT3 receptor antagonist if still necessary. Pruritus treated with clementine and if necessary, naloxone Adjuvants: none Immediate post‐op pain control: significantly reduced analgesic consumption |
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| Outcomes | Dichotomous: none Continuous: SF‐36 at 6 months Other reported: list of major and minor complications |
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| Notes | Funding sources: "the Medical Research Council of South East Sweden, Linköping University and the County Council of Östergötland supported the trial financially." Conflicts of interest: "the authors have stated explicitly that there are no conflicts of interest in connection with this article." |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "a computer generated the randomisation sequences into blocks of ten, with an equal number of the two modes of anaesthesia for each of the five participating centres" |
| Allocation concealment (selection bias) | Low risk | Quote: "the allocated mode of anaesthesia, written on a label, was sealed in opaque consecutively numbered envelopes. At each centre the envelopes were opened in consecutive number order of patient inclusion in the study" |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "blinding and/or placebo control was not possible in this study. The temporary paralysis of the lower extremities after SA would, for obvious reasons, be observed immediately by the patient, as well as by the staff. The lack of blinding may pose a risk of bias. In order to reduce such potential bias the women were informed and monitored in a standardised fashion, and the mode of incision and type of abdominal hysterectomy were decided prior to randomisation" |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported on whether outcome assessor was blinded or not |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "in the SF‐36, a missing cell was substituted by the truncated mean value of the other items in the specific subscale for the individual. If all cells in a subscale were missing, the cells were substituted by the truncated mean value of each cell in the group. If a questionnaire was missing completely on one occasion, each cell was substituted by the truncated mean value of the cell for the group on that occasion. Missing cells for the SF‐36 on all three occasions made up 0.44%, and a complete SF‐36 was missing in 2.26% (11 of 486 cases). " |
| Selective reporting (reporting bias) | Low risk | Primary outcomes fully reported |
| Null bias | Low risk | Quote: "spinal anaesthesia was associated with a significantly lower use of opioids" compared to general anaesthesia |