Local Analgesia to Prevent Pain in Patient Undergoing Removal of the Uterus Through Vaginal Route
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Ropivacaine
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Pain, Postoperative
Eligibility Criteria
Inclusion Criteria:
- Female
- 45 to 70 years old
- Scheduled for NDVH (non descent vaginal hysterectomy) for benign indications without need for oophorectomy or vaginal reconstructive surgery
Exclusion Criteria:
- Patient weight less than 50 kg
- Allergy to amide local anesthetic
- Dementia or mental retardation to a degree which would interfere with data collection
- Contraindication to non descent vaginal hysterectomy
Sites / Locations
- Banha University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
intervention group
control group
Arm Description
Participants are given ropivacaine (0.5%) at a total dose of 50 ml, 30 ml of which is injected locally and 20 ml into the peritoneum once before the end of operation as pre-emptive analgesia.
Participants are given a placebo in the form of fluid injection of saline (0.9%) at total of 50 ml, 30 ml of which is injected locally and 20 ml into the peritoneum once before the end of operation
Outcomes
Primary Outcome Measures
pain score
Pain is measured by the patient using the visual analogue score
Secondary Outcome Measures
Time in hours to get out of bed after operation
Time in hours to get out of bed after operation is measured by a nurse responsible for the patient
Hospital stay in days
Hospital stay in days is measured by a nurse
Total Narcotic dose (Nalbuphine)
Total Narcotic dose (Nalbuphine) is measured by a nurse
Total parenteral NSAID (diclofenac sodium) used in the first 24 hours after surgery
Total parenteral NSAID (diclofenac sodium) used in the first 24 hours after surgery is measured by a nurse
Proportion of patients with nausea and vomiting in the first 24 hours
Proportion of patients with nausea and vomiting in the first 24 hours is measured by a nurse
Time spent in the post-anesthesia care unit
Time spent in the post-anesthesia care unit is measured by a nurse
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03099720
Brief Title
Local Analgesia to Prevent Pain in Patient Undergoing Removal of the Uterus Through Vaginal Route
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
April 4, 2017 (Actual)
Primary Completion Date
July 25, 2017 (Actual)
Study Completion Date
September 25, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Experimental
Arm Description
Participants are given ropivacaine (0.5%) at a total dose of 50 ml, 30 ml of which is injected locally and 20 ml into the peritoneum once before the end of operation as pre-emptive analgesia.
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
Participants are given a placebo in the form of fluid injection of saline (0.9%) at total of 50 ml, 30 ml of which is injected locally and 20 ml into the peritoneum once before the end of operation
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
local anesthetic will be given locally at the site of operation to decrease the level of pain after operation
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo fluid will be given at the site of operation locally
Primary Outcome Measure Information:
Title
pain score
Description
Pain is measured by the patient using the visual analogue score
Time Frame
At 2 hours post--operatively.
Secondary Outcome Measure Information:
Title
Time in hours to get out of bed after operation
Description
Time in hours to get out of bed after operation is measured by a nurse responsible for the patient
Time Frame
at 12 hours post--operatively
Title
Hospital stay in days
Description
Hospital stay in days is measured by a nurse
Time Frame
Up to 4 weeks post-operatively
Title
Total Narcotic dose (Nalbuphine)
Description
Total Narcotic dose (Nalbuphine) is measured by a nurse
Time Frame
Up to 24 hours post--operatively
Title
Total parenteral NSAID (diclofenac sodium) used in the first 24 hours after surgery
Description
Total parenteral NSAID (diclofenac sodium) used in the first 24 hours after surgery is measured by a nurse
Time Frame
at 24 hours post-operatively
Title
Proportion of patients with nausea and vomiting in the first 24 hours
Description
Proportion of patients with nausea and vomiting in the first 24 hours is measured by a nurse
Time Frame
At 24 hours post--operatively
Title
Time spent in the post-anesthesia care unit
Description
Time spent in the post-anesthesia care unit is measured by a nurse
Time Frame
Up to 24 hours post--operatively
Other Pre-specified Outcome Measures:
Title
Pain score
Description
Pain is measured by the patient using the visual analogue score
Time Frame
At half hour post-operatively
Title
Pain score
Description
Pain is measured by the patient using the visual analogue score
Time Frame
At one hour post-operatively
Title
Pain score
Description
Pain is measured by the patient using the visual analogue score
Time Frame
At 4 hours post-operatively
Title
Pain score
Description
Pain is measured by the patient using the visual analogue score
Time Frame
At 8 hours post-operatively
Title
Pain score
Description
Pain is measured by the patient using the visual analogue score
Time Frame
At 12 hours post-operatively
Title
Pain score
Description
Pain is measured by the patient using the visual analogue score
Time Frame
At 24 hours post-operatively
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female
45 to 70 years old
Scheduled for NDVH (non descent vaginal hysterectomy) for benign indications without need for oophorectomy or vaginal reconstructive surgery
Exclusion Criteria:
Patient weight less than 50 kg
Allergy to amide local anesthetic
Dementia or mental retardation to a degree which would interfere with data collection
Contraindication to non descent vaginal hysterectomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eman Omran, M.D.
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banha University
City
Banha
State/Province
Qalubia
ZIP/Postal Code
13518
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Local Analgesia to Prevent Pain in Patient Undergoing Removal of the Uterus Through Vaginal Route
We'll reach out to this number within 24 hrs