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

Phase 4

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: Placebo; Drug: Ropivacaine

• Registration Number: NCT03099720
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-03-20
• Study First Submitted QC: 2017-03-28
• Study Start: 2017-04-04
• Study First Posted: 2017-04-04
• Primary Completion: 2017-07-25
• Study Completion: 2017-09-25
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-23
• Last Update Posted: 2018-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Placebo	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 group	Ropivacaine	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.

Primary Outcome Measures

Name	Time	Method
pain score	At 2 hours post--operatively.	Pain is measured by the patient using the visual analogue score

Secondary Outcome Measures

Name	Time	Method
Time in hours to get out of bed after operation	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	Up to 4 weeks post-operatively	Hospital stay in days is measured by a nurse
Total Narcotic dose (Nalbuphine)	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	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	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	Up to 24 hours post--operatively	Time spent in the post-anesthesia care unit is measured by a nurse

Trial Locations

Locations (1)

Banha University; 🇪🇬 Banha, Qalubia, Egypt