Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Local Analgesia to Prevent Pain in Patient Undergoing Removal of the Uterus Through Vaginal Route

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03099720
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Eman Omran, Cairo University

Tracking Information
First Submitted Date  ICMJE March 20, 2017
First Posted Date  ICMJE April 4, 2017
Last Update Posted Date January 25, 2018
Actual Study Start Date  ICMJE April 4, 2017
Actual Primary Completion Date July 25, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2017)
pain score [ Time Frame: At 2 hours post--operatively. ]
Pain is measured by the patient using the visual analogue score
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2017)
  • Time in hours to get out of bed after operation [ Time Frame: at 12 hours post--operatively ]
    Time in hours to get out of bed after operation is measured by a nurse responsible for the patient
  • Hospital stay in days [ Time Frame: Up to 4 weeks post-operatively ]
    Hospital stay in days is measured by a nurse
  • Total Narcotic dose (Nalbuphine) [ Time Frame: Up to 24 hours post--operatively ]
    Total Narcotic dose (Nalbuphine) is measured by a nurse
  • Total parenteral NSAID (diclofenac sodium) used in the first 24 hours after surgery [ Time Frame: at 24 hours post-operatively ]
    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 [ Time Frame: At 24 hours post--operatively ]
    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 Frame: Up to 24 hours post--operatively ]
    Time spent in the post-anesthesia care unit is measured by a nurse
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 28, 2017)
  • Pain score [ Time Frame: At half hour post-operatively ]
    Pain is measured by the patient using the visual analogue score
  • Pain score [ Time Frame: At one hour post-operatively ]
    Pain is measured by the patient using the visual analogue score
  • Pain score [ Time Frame: At 4 hours post-operatively ]
    Pain is measured by the patient using the visual analogue score
  • Pain score [ Time Frame: At 8 hours post-operatively ]
    Pain is measured by the patient using the visual analogue score
  • Pain score [ Time Frame: At 12 hours post-operatively ]
    Pain is measured by the patient using the visual analogue score
  • Pain score [ Time Frame: At 24 hours post-operatively ]
    Pain is measured by the patient using the visual analogue score
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Local Analgesia to Prevent Pain in Patient Undergoing Removal of the Uterus Through Vaginal Route
Official Title  ICMJE Role of Ropivacaine Postincisional Infiltration With Intraperitoneal Instillation Analgesia in Postoperative Pain Relief in Patients Undergoing Non Descent Vaginal Hysterectomy: Randomized Controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Pain, Postoperative
Intervention  ICMJE
  • Drug: Ropivacaine
    local anesthetic will be given locally at the site of operation to decrease the level of pain after operation
  • Drug: Placebo
    placebo fluid will be given at the site of operation locally
Study Arms  ICMJE
  • Experimental: intervention group
    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.
    Intervention: Drug: Ropivacaine
  • Placebo Comparator: control group
    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: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 28, 2017)
48
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 25, 2017
Actual Primary Completion Date July 25, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Female
  2. 45 to 70 years old
  3. Scheduled for NDVH (non descent vaginal hysterectomy) 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 anesthetic
  3. Dementia or mental retardation to a degree which would interfere with data collection
  4. Contraindication to non descent vaginal hysterectomy
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 45 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03099720
Other Study ID Numbers  ICMJE 3777
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Eman Omran, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eman Omran, M.D. Cairo University
PRS Account Cairo University
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP