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. 2014 Aug 15;2014(8):CD005355. doi: 10.1002/14651858.CD005355.pub5

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
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