Overview

This trial is active, not recruiting.

Condition postoperative pain
Treatment vaginal wound local analgesia after laparoscopic hysterectomy
Sponsor Helsinki University Central Hospital
Start date November 2014
End date October 2016
Trial size 81 participants
Trial identifier NCT02767544, 98/13/03/03/2014/2

Summary

In cases of laparoscopic hysterectomy , women were randomized to two groups: ropivacaine ( vaginal wound infiltration analgesia) vs. control group. Results regarding postoperative pain and need of oxycodone.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Vaginal wound local analgesia by 10ml ropivacaine 7.5mg/ml injection after laparoscopic hysterectomy
vaginal wound local analgesia after laparoscopic hysterectomy
(No Intervention)
Vaginal wound no local analgesia by 10 ml ropivacaine 7.5mg/ml injection after laparoscopic hysterectomy

Primary Outcomes

Measure
Postoperative pain scores
time frame: Change in 24 hours after surgery

Secondary Outcomes

Measure
Complication
time frame: Up to one week
Nausea
time frame: Change in 24 hours after surgery.
Length of hospitalisation
time frame: Up to one week
The use of analgesics for postoperative pain
time frame: Change in 24 hours after surgery
Vomiting
time frame: Change in 24 hours after surgery.

Eligibility Criteria

Male or female participants from 30 years up to 80 years old.

Inclusion Criteria: The criteria for inclusion were scheduled laparoscopic hysterectomy Exclusion Criteria: The exclusion Criteria were contraindications to any of the forms of medication used in the study (oxycodone, ketoprofen, paracetamol), language difficulties ( inability to understand and speak Finnish or Swedish)

Additional Information

Official title Vaginal Wound Infiltration Analgesia for Postoperative Pain After Laparoscopic Hysterectomy: a Randomized Trial
Principal investigator Päivi I Pakarinen, MD PhD
Description Women assigned to laparoscopic hysterectomy were randomly divided into two groups as regard surgery: a ropivacaine group (RG) (n=41) and a control group (CG) (n=40). General anesthesia and use of local anesthetics were standardized. Visual analog scale (VAS) scores for pain and side effects (nausea/vomiting) and the amount of postoperative analgesic used were recorded for 24 hours.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Helsinki University Central Hospital.