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

Iakentro Fertility Centre

Status: Completed

Conditions: Myomectomy; Anesthesia

Treatments: Procedure: Multimodal analgesic protocol during minimally invasive myomectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00978601

MULTI-LM-100

Details and patient eligibility

About

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)).

Enrollment: 95 patients

Sex: Female

Ages: 20 to 42 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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95 participants in 2 patient groups

Multimodal analgesic protocol group

Experimental group

Description:

Women who received the multimodal analgesic protocol during minimally invasive myomectomy.

Treatment:

Procedure: Multimodal analgesic protocol during minimally invasive myomectomy

No use of multimodal analgesic protocol group

No Intervention group

Description:

Women who did not receive the multimodal analgesic protocol during minimally invasive myomectomy.

Treatment:

Procedure: Multimodal analgesic protocol during minimally invasive myomectomy