NCT00978601

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)).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2009

Completed
Last Updated

September 17, 2009

Status Verified

September 1, 2009

Enrollment Period

2.1 years

First QC Date

September 15, 2009

Last Update Submit

September 16, 2009

Conditions

AnesthesiaMyomectomy

Keywords

post-operative analgesiaearly discharge,fast recovery,minimally invasive myomectomy,laparoscopy,laparoscopically assisted myomectomypatient dischargeAnesthesia Recovery Period

Outcome Measures

Primary Outcomes (1)

  • The main outcome measure is the Visual Analog Scale (VAS) score at 2 and 8 hours post surgery.

    2 and 8 hours post surgery.

Secondary Outcomes (1)

  • 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

Study Arms (2)

Multimodal analgesic protocol group

EXPERIMENTAL

Women who received the multimodal analgesic protocol during minimally invasive myomectomy.

Procedure: Multimodal analgesic protocol during minimally invasive myomectomy

No use of multimodal analgesic protocol group

NO INTERVENTION

Women who did not receive the multimodal analgesic protocol during minimally invasive myomectomy.

Procedure: Multimodal analgesic protocol during minimally invasive myomectomy

Interventions

Multimodal analgesic protocol during minimally invasive myomectomyPROCEDURE

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.

Multimodal analgesic protocol groupNo use of multimodal analgesic protocol group

Eligibility Criteria

Age20 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iakentro Advanced Medical Center

Thessaloniki, 54250, Greece

Location

Related Publications (5)

  • 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.

    PMID: 18262139BACKGROUND

  • 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.

    PMID: 19019334BACKGROUND

  • 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.

    PMID: 15904592BACKGROUND

  • 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.

    PMID: 17489225BACKGROUND

  • 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.

    PMID: 21806591DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 15, 2009

First Posted

September 17, 2009

Study Start

January 1, 2007

Primary Completion

February 1, 2009

Study Completion

September 1, 2009

Last Updated

September 17, 2009

Record last verified: 2009-09

Locations

GR(1)