The study is a single-center parallel group randomized controlled trial comparing the administration of a presacral nerve block using 20mL of local ropivacaine 5.0mg/ml versus 20mL of normal saline (sham block) on post-operative pain following total laparoscopic hysterectomy.
18 years of age or older
Undergoing total laparoscopic hysterectomy
Previous presacral neurectomy
Concurrent surgical procedure other than salpingectomy and/or oophorectomy
Gynecological cancer beyond stage 1 disease
BMI > 50
Parallel
Ropivacaine injection
DrugPresacral nerve block using 20mL of local ropivacaine 5.0mg/ml
Normal saline injection
DrugSham block using 20 mL of normal saline (0.9% sodium chloride)
Early post-operative pain at 3 hours following surgery
Early post-operative pain measured at 3-hours following surgery by a self-administered numeric pain rating scale (NRS) on a scale from 0 to 10, with 0 indicating no pain and 10 indicating the worst pain imaginable
Post-operative pain at other time points
Delayed post-operative pain measured by numeric pain rating scale (NRS) scores at 1 hour, 2 hour, and post-operative days 1, 2 and 7 on a scale from 0 to 10, with 0 indicating no pain and 10 indicating the worst pain imaginable
Post-operative narcotic usage
Total narcotics administered from end of surgery until post-operative days 1, 2 and 7 (calculated from the hospital medical records and pill counts from discharge medications to be elicited by phone the day after surgery)
Adverse effects/complication rates
Any negative outcome that is self-reported and elicited from a telephone survey
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