Clinical trial NCT00978601: Improved Recovery Using Multimodal Peri-operative Analgesia in Minimally Invasive Myomectomy
Official title: Improved Recovery Using Multimodal Peri-operative Analgesia in Minimally Invasive Myomectomy.A Randomized Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Myomectomy
Keywords: post-operative analgesia
early discharge,
fast recovery,
minimally invasive myomectomy,
laparoscopy,
laparoscopically assisted myomectomy
patient discharge
Anesthesia Recovery Period
Lead sponsor: Iakentro Fertility Centre
Sponsor class: OTHER
First posted: 2009-09-17
Enrollment: 95
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)).


Eligibility 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

Primary outcomes:
measure: The main outcome measure is the Visual Analog Scale (VAS) score at 2 and 8 hours post surgery.
timeFrame: 2 and 8 hours post surgery.
Secondary outcomes:
measure: hours of the bowel peristalsis return, hours of hospitalization, and number of days for the fully recuperate activity are also measured.
timeFrame: hours to few days after the intervention
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Iakentro Advanced Medical Center
Study officials:
References:
citation: 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.
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.
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. doi: 10.1016/j.jmig.2004.12.022.
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. doi: 10.1016/j.bpa.2006.12.001.
citation: Xiromeritis P, Kalogiannidis I, Papadopoulos E, Prapas N, Prapas Y. Improved recovery using multimodal perioperative analgesia in minimally invasive myomectomy: a randomised study. Aust N Z J Obstet Gynaecol. 2011 Aug;51(4):301-6. doi: 10.1111/j.1479-828X.2011.01333.x. Epub 2011 Jul 5.