Ignite Creation Date:
2024-05-06 @ 9:52 AM
Last Modification Date:
2024-10-26 @ 12:21 PM
Study NCT ID:
NCT03099720
Status:
COMPLETED
Last Update Posted:
2018-01-25
First Post:
2017-03-20
Brief Title:
Local Analgesia to Prevent Pain in Patient Undergoing Removal of the Uterus Through Vaginal Route
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Role of Ropivacaine Postincisional Infiltration With Intraperitoneal Instillation Analgesia in Postoperative Pain Relief in Patients Undergoing Non Descent Vaginal Hysterectomy Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 surgeryWomen 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
Detailed 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None