| Methods |
Allocation concealment: adequate.
Randomisation: centralised randomisation process, with sealed, opaque, sequentially numbered, identical envelopes.
Blinding: single; randomised participants were blinded.
Power Calculation: none stated.
Duration of trial: 6 months post‐operative; however follow‐up continued for a minimum of 42 months. |
| Participants |
Number of women randomised: 8; also 18 women not randomised but followed up.
Number of women analysed: 26.
Drop‐outs/withdrawals: none.
Inclusion criteria: women with moderate to severe dysmenorrhoea scheduled to undergo laparotomy for conservative resection of endometriosis.
Diagnosis: initial detailed history of pain and anatomical diagram for localisation of dysmenorrhoea, endometriosis confirmed at laparotomy.
Age: mean 30 yrs.
Location: USA. |
| Interventions |
Treatment: presacral neurectomy and resection of endometriosis.
Control: resection of endometriosis only. |
| Outcomes |
Relief of pain was reported as the number of women with pain relief in 3 locations.
Adverse effects. |
| Notes |
Data analysed pooled, and split into protocol (randomised) and non‐protocol (non‐randomised) groups. Study stopped by monitoring committee after 26 participants, as it was considered unethical not to provide those with midline dysmenorrhoea the pain relief that PSN exhibited. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
