Vaginal Wound Infiltration Analgesia for Postoperative Pain After Laparoscopic Hysterectomy: a Randomized Trial
- Conditions
- Postoperative Pain
- Registration Number
- NCT02767544
- Lead Sponsor
- Helsinki University Central Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Not specified
- Target Recruitment
- 81
The criteria for inclusion were scheduled laparoscopic hysterectomy
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Postoperative pain scores 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 Outcome Measures
Name Time Method The use of analgesics for postoperative pain Change in 24 hours after surgery Postoperative pain defined by the total amount of analgesics used. Amount of used Oxycodone (mg).
Vomiting Change in 24 hours after surgery. Vomiting after the procedure: Visual Analog Score (VAS) for vomiting. Physicians Global Assessment to measure quality of vomiting. 10-point VAS score for vomiting (0-10), 0 indicating no vomiting and 10 indicating unbearable vomiting at 1,3,6,12 and 24 h (hour) after surgery. ( Unit on scale; 0-10).
Complication Up to one week Frequency of complications. Values are given as n (%) and eventual complications are specified.
Nausea Change in 24 hours after surgery. Nausea after the procedure: Visual Analog Score (VAS) for nausea. Physicians Global Assessment to measure quality of nausea. 10-point VAS score for nausea (0-10), 0 indicating no nausea and 10 indicating unbearable nausea at 1,3,6,12 and 24 h (hour) after surgery. ( Unit on scale; 0-10).
Length of hospitalisation Up to one week Length of hospital stay measured from the end of the operation until discharge
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