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Completed

NCT Number: NCT00978601

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

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)).

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Key information

Conditions

Anesthesia Myomectomy

Age range

20 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Iakentro Advanced Medical Center

Thessaloniki, 54250, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multimodal analgesic protocol during minimally invasive myomectomy

Procedure

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.

Primary outcomes

  1. 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

  1. 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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Iakentro Fertility Centre

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Sep 17, 2009
Registry last updated
Sep 17, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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