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

NCT03099720 | Completed Phase 4

• 1 other identifier: 3777
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• pain score

  Pain is measured by the patient using the visual analogue score

  At 2 hours post--operatively.

Secondary Outcomes (6)

• Time in hours to get out of bed after operation

  at 12 hours post--operatively

• Hospital stay in days

  Up to 4 weeks post-operatively

• Total Narcotic dose (Nalbuphine)

  Up to 24 hours post--operatively

• Total parenteral NSAID (diclofenac sodium) used in the first 24 hours after surgery

  at 24 hours post-operatively

• Proportion of patients with nausea and vomiting in the first 24 hours

  At 24 hours post--operatively

Other Outcomes (6)

• Pain score

  At half hour post-operatively

• Pain score

  At one hour post-operatively

• Pain score

  At 4 hours post-operatively

Study Arms (2)

intervention group

EXPERIMENTAL

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

control group

PLACEBO COMPARATOR

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

Interventions

Ropivacaine DRUG

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

intervention group

Placebo DRUG

placebo fluid will be given at the site of operation locally

control group

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• to 70 years old
• Scheduled for NDVH (non descent vaginal hysterectomy) for benign indications without need for oophorectomy or vaginal reconstructive surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Banha University

Banhā, Qalyubia Governorate, 13518, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Eman Omran, M.D.

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: April 4, 2017
• Study Start: April 4, 2017
• Primary Completion: July 25, 2017
• Study Completion: September 25, 2017
• Last Updated: January 25, 2018

Record last verified: 2018-01

Locations

EG (1)