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

This study has been completed.
Sponsor:
Information provided by:
Iakentro Fertility Centre
ClinicalTrials.gov Identifier:
NCT00978601
First received: September 15, 2009
Last updated: September 16, 2009
Last verified: September 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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. ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   20 Years to 42 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00978601

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

Publications:
Additional 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
Study First Received: September 15, 2009
Last Updated: September 16, 2009
Health Authority: Greece: Ethics Committee

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014