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Clinical Trial Summary

Following a hysterectomy, women tend to experience high levels of pain, and many require strong pain killers after the procedure. Ropivacaine is a local anaesthetic drug (injectable numbing medication) which works by blocking pain signals. The aim of this study is to find out whether injections of ropivacaine during surgery can help provide effective pain relief after surgery.Women aged between 45 and 70 who are having a vaginal hysterectomy can participate in the trial. Participants are randomly allocated to one of two groups. Those in the first group are given injections of ropivacaine at the site of the wound and in the peritoneum (space in the body that holds the organs in the abdomen) and those in the second group are given injections of a saline fluid in the same places that offers no pain relief before the end of their surgery. Participants in both groups are then regularly asked to rate their pain levels up to 24 hours after surgery. In addition, the pain killers they receive and length of hospital stay are recorded. There is a chance that the participants who receive the ropivacaine will benefit from lower pain levels after surgery. There are no notable risks of participating.


Clinical Trial Description

At end of the vaginal hysterectomy operation, the gynecologist will inject the uterosacral, cardinal ligaments, adnexal areas and the vaginal edge with 15 ml of either the ropivacaine solution or the placebo fluid in each side, then 20 ml will be instilled inside the peritoneum. Analgesia will be given on request after operation. Visual analogue score of 0 to 100 mm will be used to assess the degree of pain, with 0 indicating no pain and 100 indicating worst pain. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03099720
Study type Interventional
Source Cairo University
Contact
Status Completed
Phase Phase 4
Start date April 4, 2017
Completion date September 25, 2017

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