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

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:

MedlinePlus related topics: Uterine Fibroids

U.S. FDA Resources

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.

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

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:

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.

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. Epub 2008 Nov 18.

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.

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2011 Jul 5.

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 May 16, 2013