Zullo 2004.
Methods | Single centre study Allocation by envelopes containing computer‐generated random numbers Patients and care providers were blinded Power calculation: performed 4 (6.7%) patients (2 in each arm ) did not receive the assigned intervention because of concomitant disease (endometriosis) Withdrawals were excluded from the analysis | |
Participants | Setting: university hospital in Naples, Italy Inclusion criteria: symptomatic fibroids Exclusion criteria: liver disease, angina or ischaemic heart disease, chronic obstructive pulmonary disease, dyslipidaemia, diabetes, acute or recent vascular thrombosis, malignancy, intramural largest myoma less than 3 cm, or more than 5 cm, more than 2 myomas, calcification or hypoechoic leiomyoma, submucosal fibroids, cytologic evidence of endometrial atypia, abnormal Pap smear, or positive urine pregnancy test n = 60 Mean age: 28.2 years (SD 3.1) for treatment arm and 27.1 years (SD 2.9) for control arm Ethnicity: not described Number of myomas: mean 1.3 (SD 0.4) in treatment arm and 1.2 (SD 0.3) in control arm | |
Interventions | Treatment arm (n = 30): 50 ml of bupivacaine cloridrate 0.25% + 0.5 ml of epinephrine infiltrated into the serosa or myometrium overlying and just around the myoma before incision Control (n = 30): infiltration of normal saline Type of operation: laparoscopy | |
Outcomes | Perioperative blood loss, and operation time Blood loss was estimated from the balance between the aspirated and the irrigated liquid | |
Notes | Indications for myomectomy: history of infertility for more than 3 years, recurrent abortions during first trimester, increased vaginal bleeding, pelvic pressure and pain, urinary frequency, and constipation Author not contacted |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Allocation by envelopes containing computer‐generated random numbers |
Allocation concealment (selection bias) | Low risk | Adequate |
Incomplete outcome data (attrition bias) All outcomes | High risk | 4 (6.7%) patients (2 in each arm ) did not receive the assigned intervention because of concomitant disease (endometriosis) |
Selective reporting (reporting bias) | Unclear risk | We do not have access to the study protocol |
Other bias | Low risk | No other sources of bias identified |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Patients and care providers were blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors were blinded |