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

Study Overview
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Brief Summary
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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)).

Official Title
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Improved Recovery Using Multimodal Peri-operative Analgesia in Minimally Invasive Myomectomy.A Randomized Study.

Conditions
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Anesthesia, Myomectomy

Intervention / Treatment
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* Procedure: Multimodal analgesic protocol during minimally invasive myomectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multimodal analgesic protocol group<br>Women who received the multimodal analgesic protocol during minimally invasive myomectomy. | Procedure: Multimodal analgesic protocol during minimally invasive myomectomy<br>* 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.<br>|
| No Intervention: No use of multimodal analgesic protocol group<br>Women who did not receive the multimodal analgesic protocol during minimally invasive myomectomy. | Procedure: Multimodal analgesic protocol during minimally invasive myomectomy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The main outcome measure is the Visual Analog Scale (VAS) score at 2 and 8 hours post surgery. |  | 2 and 8 hours post surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hours of the bowel peristalsis return, hours of hospitalization, and number of days for the fully recuperate activity are also measured. |  | hours to few days after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post-operative analgesia, early discharge,, fast recovery,, minimally invasive myomectomy,, laparoscopy,, laparoscopically assisted myomectomy, patient discharge, Anesthesia Recovery Period