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

Not Applicable

• Conditions: Postoperative Pain
• Interventions: Procedure: Vaginal wound local analgesia after laparoscopic hysterectomy

• 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.

Study Timeline

• Study Start: 2014-11
• Status Verified: 2016-05
• Study First Submitted: 2016-05-02
• Study First Submitted QC: 2016-05-09
• Last Update Submitted: 2016-05-09
• Study First Posted: 2016-05-10
• Last Update Posted: 2016-05-10
• Primary Completion: 2016-10
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Not specified
• Target Recruitment: 81

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ropivacaine group	Vaginal wound local analgesia after laparoscopic hysterectomy	Vaginal wound local analgesia by 10ml ropivacaine 7.5mg/ml injection after laparoscopic hysterectomy

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
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
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).