| Methods |
Randomized controlled trial. Randomization by permuted block technique in sets of four, with blocks randomly ordered by use of a random number table. Ordered opaque sealed envelopes used. Allocation verification done. Double‐blind regarding solution injected, but not regarding injection technique.
Per power analys 18 patients per group required and a total of 72.
Planned Parenthood of the Rochester Syracuse Region, NY, USA. Study length: October 1997 to January 1999. |
| Participants |
82 pregnant women. Age: 18 years and older. Gestational age: 7‐12 weeks by LMP and phyisical exam, with sonogram if needed. Exclusion criteria: significant medical condition increasing risk for complication from procedure in clinic setting |
| Interventions |
Group 1: paracervical block at 3‐5‐7‐9 o'clock with 5‐2‐2‐5ml of 1% chloroprocaine.
Group 2: paracervical block at 3‐5‐7‐9 o'clock with 5‐2‐2‐5ml of bacteriostatic (0.9% benzyl alcohol) saline.
Group 3: paracervical block at 4‐8o'clock with 7‐7ml of 1% chloroprocaine.
Group 4: paracervical block at 4‐8o'clock with 7‐7ml of bacteriostatic (0.9% benzyl alcohol) saline.
All participants: Laminaria insertion the day prior to the procedure. Iboprofen 600mg po 1hr prior to the procedure. No po or IV sedation.
Procedure started 3 minutes after paracervical block administration.
Mechanical vauum aspiration followed by sharp curettage and a final pass with suction. |
| Outcomes |
Patient reported pain on a 10 point box scale (0 = no pain, 10 = worst imaginable pain) with: laminaria insertion, paracervical block administration (measured immediately after administration), aspiration (measured immediately after procedure), recovery room recollection of pain associated with the abortion procedure.
Dysmenorrhea prior to conception, anxiety regarding the procedure measured on a 10 point box scale and associated with painful laminaria insertion. |
| Notes |
Analysis included 79 patients, since 2 changed their mind just after randomization and before receiving the PCB. Another patient turned out to have a gestational age of 15wks after the PCB was administered.
Dysmenorrhea was also associated with and more painful paracervical block administration and aspiration. No anesthetic complication. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
