Sears 1994.
Methods |
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Participants | 1. 375 ASA physical status I and II caesarean section and postpartum tubal ligation patients at 4 hospitals participated in the study Exclusion criteria: unclear Patients randomized to:
2. No patients were excluded from further analysis 3. Main characteristics of patients:
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Interventions | 1. 22 G Sprotte needle 2. 24 G Sprotte needle All patients received an infusion of at least 1000 mL of lactated Ringer's solution over 30 minutes prior to the block |
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Outcomes | Outcomes were not classified as primary or secondary 1. Complication: headache 2. PDPH 3. Severity of PDPH |
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Notes |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information to score this item as low or high risk of bias. Quote: "Patients were randomly assigned to receive" (page 43) |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to score this item as low or high risk of bias |
Blinding of participants (performance bias) | Unclear risk | Insufficient information to score this item as low or high risk of bias |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Patients were visited at least once by the anesthesiologist during the postoperative period, and nurses on the obstetrics floor were instructed to notify the anesthesiologist of any complication, including headache. In addition, patients were contacted by telephone 1 week or more after discharge by an investigator who was blinded to the type of needle used." (page 43) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No patients were lost to follow‐up |
Selective reporting (reporting bias) | High risk | Adverse events, additional to PDPH, were not reported |
Other bias | Low risk | No other biases were identified |