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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Ropivacaine; Drug: Placebo

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: Interventional
• Enrollment (Actual): 48
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Qalubia
    • Banha, Qalubia, Egypt, 13518
      • Banha University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain score	Pain is measured by the patient using the visual analogue score	At 2 hours post--operatively.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at 12 hours post--operatively
Hospital stay in days	Hospital stay in days is measured by a nurse	Up to 4 weeks post-operatively
Total Narcotic dose (Nalbuphine)	Total Narcotic dose (Nalbuphine) is measured by a nurse	Up to 24 hours post--operatively
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	at 24 hours post-operatively
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	At 24 hours post--operatively
Time spent in the post-anesthesia care unit	Time spent in the post-anesthesia care unit is measured by a nurse	Up to 24 hours post--operatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	Pain is measured by the patient using the visual analogue score	At half hour post-operatively
Pain score	Pain is measured by the patient using the visual analogue score	At one hour post-operatively
Pain score	Pain is measured by the patient using the visual analogue score	At 4 hours post-operatively
Pain score	Pain is measured by the patient using the visual analogue score	At 8 hours post-operatively
Pain score	Pain is measured by the patient using the visual analogue score	At 12 hours post-operatively
Pain score	Pain is measured by the patient using the visual analogue score	At 24 hours post-operatively

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Eman Omran, M.D., Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2017
• Primary Completion (Actual): July 25, 2017
• Study Completion (Actual): September 25, 2017

Study Registration Dates

• First Submitted: March 20, 2017
• First Submitted That Met QC Criteria: March 28, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): January 25, 2018
• Last Update Submitted That Met QC Criteria: January 23, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 3777

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No