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

Helsinki University Central Hospital81 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Postoperative Pain

Interventions

Vaginal wound local analgesia after laparoscopic hysterectomyPROCEDURE

Eligibility

Min age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

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).

Time frame: Change in 24 hours after surgery

Secondary Outcomes

Complication

Frequency of complications. Values are given as n (%) and eventual complications are specified.

Time frame: 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).

Time frame: Change in 24 hours after surgery.

Length of hospitalisation

Length of hospital stay measured from the end of the operation until discharge

Time frame: 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).

Time frame: 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).

Time frame: Change in 24 hours after surgery.

Data from ClinicalTrials.gov

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