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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Procedure: Vaginal wound local analgesia after laparoscopic hysterectomy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years


Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ropivacaine group<br>Vaginal wound local analgesia by 10ml ropivacaine 7.5mg/ml injection after laparoscopic hysterectomy | Procedure: Vaginal wound local analgesia after laparoscopic hysterectomy<br> <br> |
| No Intervention: Control group<br>Vaginal wound no local analgesia by 10 ml ropivacaine 7.5mg/ml injection after laparoscopic hysterectomy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain scores | 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). | Change in 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication | Frequency of complications. Values are given as n (%) and eventual complications are specified. | Up to one week | 
| Nausea | 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). | Change in 24 hours after surgery. | 
| Length of hospitalisation | Length of hospital stay measured from the end of the operation until discharge | Up to one week | 
| The use of analgesics for postoperative pain | Postoperative pain defined by the total amount of analgesics used. Amount of used Oxycodone (mg). | Change in 24 hours after surgery | 
| Vomiting | 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). | Change in 24 hours after surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopic hysterectomy, postoperative pain, local analgesia, vaginal wound