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

Not Applicable

Completed

• Conditions: Anesthesia; Myomectomy
• Interventions: Procedure: Multimodal analgesic protocol during minimally invasive myomectomy

• Registration Number: NCT00978601
• Lead Sponsor: Iakentro Fertility Centre

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)).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2009-02
• Status Verified: 2009-09
• Study Completion: 2009-09
• Study First Submitted: 2009-09-15
• Study First Submitted QC: 2009-09-16
• Last Update Submitted: 2009-09-16
• Study First Posted: 2009-09-17
• Last Update Posted: 2009-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 95

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multimodal analgesic protocol group	Multimodal analgesic protocol during minimally invasive myomectomy	Women who received the multimodal analgesic protocol during minimally invasive myomectomy.
No use of multimodal analgesic protocol group	Multimodal analgesic protocol during minimally invasive myomectomy	Women who did not receive the multimodal analgesic protocol during minimally invasive myomectomy.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Iakentro Advanced Medical Center; 🇬🇷 Thessaloniki, Greece