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Completed

NCT Number: NCT03099720

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

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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

45 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Banha University

Banhā, Qalyubia Governorate, 13518, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine

Drug

local anesthetic will be given locally at the site of operation to decrease the level of pain after operation

Placebo

Drug

placebo fluid will be given at the site of operation locally

Primary outcomes

  1. pain score

    Time frame: At 2 hours post--operatively.

    Pain is measured by the patient using the visual analogue score

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Role of Ropivacaine Postincisional Infiltration With Intraperitoneal Instillation Analgesia in Postoperative Pain Relief in Patients Undergoing Non Descent Vaginal Hysterectomy: Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 4, 2017
Registry last updated
Jan 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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