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

September 16, 2009 updated by: Iakentro Fertility Centre

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

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)).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloniki, Greece, 54250
        • Iakentro Advanced Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
2 and 8 hours post surgery.

Secondary Outcome Measures

Outcome Measure
Time Frame
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
hours to few days after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Iakentro Fertility Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

September 15, 2009

First Submitted That Met QC Criteria

September 16, 2009

First Posted (Estimate)

September 17, 2009

Study Record Updates

Last Update Posted (Estimate)

September 17, 2009

Last Update Submitted That Met QC Criteria

September 16, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MULTI-LM-100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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