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Clinical Trials/NCT02767544
NCT02767544
Unknown
Not Applicable

Vaginal Wound Infiltration Analgesia for Postoperative Pain After Laparoscopic Hysterectomy: a Randomized Trial

Helsinki University Central Hospital0 sites81 target enrollmentNovember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Pain
Sponsor
Helsinki University Central Hospital
Enrollment
81
Primary Endpoint
Postoperative pain scores
Last Updated
9 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
November 2014
End Date
October 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Päivi Päkarinen

MD PhD

Helsinki University Central Hospital

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Postoperative pain scores

Time Frame: Change in 24 hours after surgery

Visual Analog Score (VAS) for pain. Physicians Global Assessment to measure quality of pain. 10-point VAS score for pain (0-10), 0 indicating no pain and 10 indicating unbearable pain at 1,3,6,12 and 24 h (hour) after surgery (Units on a Scale; 0-10).

Secondary Outcomes

  • Complication(Up to one week)
  • Nausea(Change in 24 hours after surgery.)
  • Length of hospitalisation(Up to one week)
  • The use of analgesics for postoperative pain(Change in 24 hours after surgery)
  • Vomiting(Change in 24 hours after surgery.)

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