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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

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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Ropivacaine Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : April 4, 2017
Actual Primary Completion Date : July 25, 2017
Actual Study Completion Date : September 25, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Ropivacaine
local anesthetic will be given locally at the site of operation to decrease the level of pain after operation

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
Drug: Placebo
placebo fluid will be given at the site of operation locally




Primary Outcome Measures :
  1. pain score [ Time Frame: At 2 hours post--operatively. ]
    Pain is measured by the patient using the visual analogue score


Secondary Outcome Measures :
  1. 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

  2. Hospital stay in days [ Time Frame: Up to 4 weeks post-operatively ]
    Hospital stay in days is measured by a nurse

  3. Total Narcotic dose (Nalbuphine) [ Time Frame: Up to 24 hours post--operatively ]
    Total Narcotic dose (Nalbuphine) is measured by a nurse

  4. 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

  5. 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

  6. 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


Other Outcome Measures:
  1. Pain score [ Time Frame: At half hour post-operatively ]
    Pain is measured by the patient using the visual analogue score

  2. Pain score [ Time Frame: At one hour post-operatively ]
    Pain is measured by the patient using the visual analogue score

  3. Pain score [ Time Frame: At 4 hours post-operatively ]
    Pain is measured by the patient using the visual analogue score

  4. Pain score [ Time Frame: At 8 hours post-operatively ]
    Pain is measured by the patient using the visual analogue score

  5. Pain score [ Time Frame: At 12 hours post-operatively ]
    Pain is measured by the patient using the visual analogue score

  6. Pain score [ Time Frame: At 24 hours post-operatively ]
    Pain is measured by the patient using the visual analogue score



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099720


Locations
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Egypt
Banha University
Banha, Qalubia, Egypt, 13518
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Eman Omran, M.D. Cairo University
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Responsible Party: Eman Omran, Principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03099720    
Other Study ID Numbers: 3777
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents