Clinical trial NCT03099720: Local Analgesia to Prevent Pain in Patient Undergoing Removal of the Uterus Through Vaginal Route
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 48
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: pain score
timeFrame: At 2 hours post--operatively.
Secondary outcomes:
measure: Time in hours to get out of bed after operation
timeFrame: at 12 hours post--operatively
measure: Hospital stay in days
timeFrame: Up to 4 weeks post-operatively
measure: Total Narcotic dose (Nalbuphine)
timeFrame: Up to 24 hours post--operatively
measure: Total parenteral NSAID (diclofenac sodium) used in the first 24 hours after surgery
timeFrame: at 24 hours post-operatively
measure: Proportion of patients with nausea and vomiting in the first 24 hours
timeFrame: At 24 hours post--operatively
measure: Time spent in the post-anesthesia care unit
timeFrame: Up to 24 hours post--operatively
Other outcomes:
measure: Pain score
timeFrame: At half hour post-operatively
measure: Pain score
timeFrame: At one hour post-operatively
measure: Pain score
timeFrame: At 4 hours post-operatively
measure: Pain score
timeFrame: At 8 hours post-operatively
measure: Pain score
timeFrame: At 12 hours post-operatively
measure: Pain score
timeFrame: At 24 hours post-operatively
Locations:
city: Banha
country: Egypt
facility: Banha University
state: Qalubia
Study officials:
affiliation: Cairo University
name: Eman Omran, M.D.
role: PRINCIPAL_INVESTIGATOR
References: