Improved Recovery Using Multimodal Peri-operative Analgesia in Minimally Invasive Myomectomy

Iakentro Fertility Centre95 enrolled

Overview

The purpose of this study is to evaluate a multimodal analgesic protocol used in minimally invasive surgery for myomectomies (laparoscopic myomectomy (LM) and laparoscopically assisted myomectomy (LAM)).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Anesthesia Myomectomy

Interventions

Multimodal analgesic protocol during minimally invasive myomectomyPROCEDURE

Multimodal and preemptive analgesia using 8 mg of Dexamethasone iv,trocar ports infiltration with 5 mL of a local anesthetic, consisting of 0.26% ropivacaine HCL (7.5 mg/mL) and 0.74% of 0,9 % sodium chloride, before the skin incision. About 10 minutes before the surgery is completed, 4 mg Ondansetron iv and a mixture of 75 mg diclofenac and 600 mg of paracetamol intramuscularly (im) are administered.

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 42 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Symptomatic intramural and or subserous myomas * ASA score 1-2 * Without contraindication to nonsteroidal anti-inflammatory agents * Patients have to be able to understand and follow medical instructions * They need to have satisfactory hygiene and accommodation conditions * They have to live not more than 2 hours away from the department * Easy telephone contact is required Exclusion Criteria: * Ovarian disease * Previous medical treatment for ovarian suppression, pregnancy, abnormal Papanicolaou (Pap) test smear or hyperplasia (with or without atypia) in case of endometrial biopsy

Locations (1)

Iakentro Advanced Medical Center

Thessaloniki, Greece

Outcomes

Primary Outcomes

The main outcome measure is the Visual Analog Scale (VAS) score at 2 and 8 hours post surgery.

Time frame: 2 and 8 hours post surgery.

Secondary Outcomes

hours of the bowel peristalsis return, hours of hospitalization, and number of days for the fully recuperate activity are also measured.

Time frame: hours to few days after the intervention

Data from ClinicalTrials.gov

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