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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00978601
First Posted: September 17, 2009
Last Update Posted: September 17, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Iakentro Fertility Centre
  Purpose
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)).

Condition Intervention
Anesthesia Myomectomy Procedure: Multimodal analgesic protocol during minimally invasive myomectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improved Recovery Using Multimodal Peri-operative Analgesia in Minimally Invasive Myomectomy.A Randomized Study.

Resource links provided by NLM:


Further study details as provided by Iakentro Fertility Centre:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 95
Study Start Date: January 2007
Study Completion Date: September 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00978601


Locations
Greece
Iakentro Advanced Medical Center
Thessaloniki, Greece, 54250
Sponsors and Collaborators
Iakentro Fertility Centre
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Panos Xiromeritis MD, Iakentro Advanced Medical Center
ClinicalTrials.gov Identifier: NCT00978601     History of Changes
Other Study ID Numbers: MULTI-LM-100
First Submitted: September 15, 2009
First Posted: September 17, 2009
Last Update Posted: September 17, 2009
Last Verified: September 2009

Keywords provided by Iakentro Fertility Centre:
post-operative analgesia
early discharge,
fast recovery,
minimally invasive myomectomy,
laparoscopy,
laparoscopically assisted myomectomy
patient discharge
Anesthesia Recovery Period

Additional relevant MeSH terms:
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs