Improved Recovery Using Multimodal Peri-operative Analgesia in Minimally Invasive Myomectomy
NCT ID: NCT00978601
Last Updated: 2009-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
95 participants
INTERVENTIONAL
2007-01-31
2009-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Analgesic Effect of Trigger Point Injection and EMLA for Shoulder Pain in Laparoscopic Hysterectomy
NCT01845532
Multimodal Pain Management After Robotic-Assisted Total Laparoscopic Hysterectomy
NCT04429022
Observational Retrospective Study on Spinal Analgesia in Laparoscopic and Laparotomic Hysterectomy
NCT05654363
Management of Symptomatic Uterine Fibroids in Pregnancy by Laparotomic Myomectomy: a Prospective Cohort Study
NCT06009562
GnRH Agonist Pretreatment in Hysteroscopic Myomectomy
NCT01873378
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Multimodal analgesic protocol group
Women who received the multimodal analgesic protocol during minimally invasive myomectomy.
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 use of multimodal analgesic protocol group
Women who did not receive the multimodal analgesic protocol during minimally invasive myomectomy.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Previous medical treatment for ovarian suppression, pregnancy, abnormal Papanicolaou (Pap) test smear or hyperplasia (with or without atypia) in case of endometrial biopsy
20 Years
42 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Iakentro Fertility Centre
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Iakentro Advanced Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Iakentro Advanced Medical Center
Thessaloniki, , Greece
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MULTI-LM-100
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.