|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ISRCTN |
|
Last refreshed on:
|
3 April 2017 |
|
Main ID: |
ISRCTN59760944 |
|
Date of registration:
|
07/03/2017 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Role of analgesia given in the peritoneum and through the site of wound before the end of operation in patients undergoing removal of undescended uterus through the vaginal route
|
|
Scientific title:
|
Role of ropivacaine postincisional infiltration with intraperitoneal instillation analgesia in postoperative pain relief in patients undergoing non descent vaginal hysterectomy: Randomized controlled trial
|
|
Date of first enrolment:
|
20/01/2014 |
|
Target sample size:
|
42 |
|
Recruitment status: |
Completed |
|
URL:
|
http://isrctn.com/ISRCTN59760944 |
|
Study type:
|
Interventional |
|
Study design:
|
Double-blind randomised controlled trial (Prevention)
|
|
Phase:
|
Not Applicable
|
|
|
Countries of recruitment
|
|
Egypt
| | | | | | | |
|
Contacts
|
|
Name:
|
Eman
Omran |
|
Address:
|
Department of Obstetrics and Gynecology
Faculty of Medicine
Al-Saray Street
11956
Cairo
Egypt |
|
Telephone:
|
+20 22 3682030 |
|
Email:
|
eman.omran@kasralaini.edu.eg |
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: 1. Female
2. 45 to 70 years old
3. Scheduled for NDVH for benign indications without need for oophorectomy or vaginal reconstructive surgery
Exclusion criteria: 1. Patient weight less than 50 kg
2. Allergy to amide local anathetic
3. Dementia or mental retardation to a degree which would interfere with data collection
4. Contraindication to non descent vaginal hysterectomy
Age minimum:
Age maximum:
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
Non descent vaginal hysterectomy
Surgery
Non descent vaginal hysterectomy
|
|
Intervention(s)
|
Participants are randomised to one of two groups in a 1:1 ratio using computer generated block randomisation.
Intervention group: Participants are given ropivacaine at a total dose of 50 ml, 30 ml of which is injected locally and 20 ml into the peritoneum before the end of operation as pre-emptive analgesia.
Control group: Participants are given a fluid injection of saline at total of 50 ml, 30 ml of which is injected locally and 20 ml into the peritoneum before the end of operation.
Participants in both groups are assessed for side-effects and pain levels 0.5, 1, 2, 4, 8, 12 and 24 hours post-operatively.
|
|
Primary Outcome(s)
|
|
Pain is measured using the visual analogue score at 0.5, 1, 2, 4, 8, 12 and 24 hours post-operatively.
|
|
Secondary Outcome(s)
|
1. Time in hours to get out of bed after operation is measured by nurse responsible for the patient at 8 and 12 hours post-operatively
2. Hospital stay in days is measured by nurse at time of discharge of the patient
3. Total Narcotic dose (Nalbuphine) is measured by nurse at 1 and 24 hours post-operatively
4. Total parentral NSAID (diclofenac sodium) used in the first 24 hours after surgery is measured by nurse at 24 hours post-operatively
5. Number and proportion of patients with nausea and vomiting in the first 24 hours is measured by nurse at 24 hours post-operatively
6. Time spent in the post-anethesia care unit is measured by nurse at time of discharge from the post-anethesia care unit
|
|
Source(s) of Monetary Support
|
|
Benha University
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|