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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00978601
• Other study ID #: MULTI-LM-100
• Status: Completed
• Phase: N/A
• First received: September 15, 2009
• Last updated: September 16, 2009
• Start date: January 2007
• Est. completion date: September 2009

Study information

• Verified date: September 2009
• Source: Iakentro Fertility Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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)).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: September 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 42 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia
• Myomectomy

Intervention

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.

Locations

Country	Name	City	State
Greece	Iakentro Advanced Medical Center	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Iakentro Fertility Centre

Country where clinical trial is conducted

Greece, 

References & Publications (4)

de Lapasse C, Rabischong B, Bolandard F, Canis M, Botchorischvili R, Jardon K, Mage G. Total laparoscopic hysterectomy and early discharge: satisfaction and feasibility study. J Minim Invasive Gynecol. 2008 Jan-Feb;15(1):20-5. doi: 10.1016/j.jmig.2007.08.608. — View Citation

Hoffman CP, Kennedy J, Borschel L, Burchette R, Kidd A. Laparoscopic hysterectomy: the Kaiser Permanente San Diego experience. J Minim Invasive Gynecol. 2005 Jan-Feb;12(1):16-24. — View Citation

Kehlet H, Wilkinson RC, Fischer HB, Camu F; Prospect Working Group. PROSPECT: evidence-based, procedure-specific postoperative pain management. Best Pract Res Clin Anaesthesiol. 2007 Mar;21(1):149-59. Review. — View Citation

Prapas Y, Kalogiannidis I, Prapas N. Laparoscopy vs laparoscopically assisted myomectomy in the management of uterine myomas: a prospective study. Am J Obstet Gynecol. 2009 Feb;200(2):144.e1-6. doi: 10.1016/j.ajog.2008.08.063. Epub 2008 Nov 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The main outcome measure is the Visual Analog Scale (VAS) score at 2 and 8 hours post surgery.		2 and 8 hours post surgery.	No
Secondary	hours of the bowel peristalsis return, hours of hospitalization, and number of days for the fully recuperate activity are also measured.		hours to few days after the intervention	Yes