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

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03099720
• Other study ID #: 3777
• Status: Completed
• Phase: Phase 4
• First received: March 20, 2017
• Last updated: January 23, 2018
• Start date: April 4, 2017
• Est. completion date: September 25, 2017

Study information

• Verified date: January 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 25, 2017
• Est. primary completion date: July 25, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Ropivacaine
local anesthetic will be given locally at the site of operation to decrease the level of pain after operation
• Placebo
placebo fluid will be given at the site of operation locally

Locations

Country	Name	City	State
Egypt	Banha University	Banha	Qalubia

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain score	Pain is measured by the patient using the visual analogue score	At half hour post-operatively
Other	Pain score	Pain is measured by the patient using the visual analogue score	At one hour post-operatively
Other	Pain score	Pain is measured by the patient using the visual analogue score	At 4 hours post-operatively
Other	Pain score	Pain is measured by the patient using the visual analogue score	At 8 hours post-operatively
Other	Pain score	Pain is measured by the patient using the visual analogue score	At 12 hours post-operatively
Other	Pain score	Pain is measured by the patient using the visual analogue score	At 24 hours post-operatively
Primary	pain score	Pain is measured by the patient using the visual analogue score	At 2 hours post--operatively.
Secondary	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
Secondary	Hospital stay in days	Hospital stay in days is measured by a nurse	Up to 4 weeks post-operatively
Secondary	Total Narcotic dose (Nalbuphine)	Total Narcotic dose (Nalbuphine) is measured by a nurse	Up to 24 hours post--operatively
Secondary	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
Secondary	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
Secondary	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