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

Iakentro Fertility Centre1 site in 1 country95 target enrollmentJanuary 2007

ConditionsAnesthesia Myomectomy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Anesthesia
Sponsor: Iakentro Fertility Centre
Enrollment: 95
Locations: 1
Primary Endpoint: The main outcome measure is the Visual Analog Scale (VAS) score at 2 and 8 hours post surgery.
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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)).

Registry

clinicaltrials.gov

Start Date

January 2007

End Date

September 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Iakentro Fertility Centre

Eligibility Criteria

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

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.(hours to few days after the intervention)