Plain English Summary
Background and study aims
A hysterectomy is a surgical procedure to remove the womb (uterus). This can be done in a number of ways, including through a cut in the top of the vagina (vaginal hysterectomy), through a cut in the lower tummy (abdominal hysterectomy) or through several small cuts in the tummy (laparoscopic hysterectomy). There are many reasons for undergoing a hysterectomy, including cancer and non-cancerous conditions of the female reproductive system. 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.
Who can participate?
Women aged between 45 and 70 who are having a vaginal hysterectomy.
What does the study involve?
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 infections of a fluid in the same places that offers no pain relief (salt water) 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 is recorded.
What are the possible benefits and risks of participating?
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.
Where is the study run from?
Benha University Hospital (Egypt)
When is the study starting and how long is it expected to run for?
November 2013 to April 2016
Who is funding the study?
Benha University (Egypt)
Who is the main contact?
Dr Eman Omran
eman.omran@kasralaini.edu.eg
Trial website
Contact information
Type
Scientific
Primary contact
Dr Eman Omran
ORCID ID
Contact details
Department of Obstetrics and Gynecology
Faculty of Medicine
Al-Saray Street
Cairo
11956
Egypt
+20 22 3682030
eman.omran@kasralaini.edu.eg
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
563476
Study information
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
Acronym
Study hypothesis
The aim of this study is to establish whether ropivacaine postincisional infiltration with intraperitoneal instillation analgesia is effective in providing postoperative pain relief in patients undergoing non-descent vaginal hysterectomy.
Ethics approval
Internal Ethical Committee of Department of Obstetrics and Gynecology, 10/12/2013, ref: 344561
Study design
Double-blind randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
No participant information sheet available
Condition
Non descent vaginal hysterectomy
Intervention
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.
Intervention type
Drug
Phase
Not Applicable
Drug names
Ropivacaine
Primary outcome measures
Pain is measured using the visual analogue score at 0.5, 1, 2, 4, 8, 12 and 24 hours post-operatively.
Secondary outcome measures
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
Overall trial start date
01/11/2013
Overall trial end date
15/04/2016
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Minimum of 42
Participant 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
Recruitment start date
20/01/2014
Recruitment end date
10/01/2016
Locations
Countries of recruitment
Egypt
Trial participating centre
Benha University Hospital
Fareed Nada Street
Benha
13511
Egypt
Funders
Funder type
University/education
Funder name
Benha University
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
31/12/2017
Participant level data
To be made available at a later date
Results - basic reporting
Publication summary