AnesthesiaNCT00978601
Improved Recovery Using Multimodal Peri-operative Analgesia in Minimally Invasive Myomectomy
A study testing Multimodal analgesic protocol during minimally invasive myomectomy in people with Anesthesia and Myomectomy, run by Iakentro Fertility Centre at 1 site in Greece.
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)). Read more about this study
- Who is it for?
- Ages 20 to 42 years, women only
- Conditions the study is for
- Anesthesia, Myomectomy
- What is being tested?
- Multimodal analgesic protocol during minimally invasive myomectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2007to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improved Recovery Using Multimodal Peri-operative Analgesia in Minimally Invasive Myomectomy.A Randomized Study.
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)).
- Conditions
- Anesthesia, Myomectomy
- Being tested
- Multimodal analgesic protocol during minimally invasive myomectomy
- Keywords
- post-operative analgesia, early discharge,, fast recovery,, minimally invasive myomectomy,, laparoscopy,, laparoscopically assisted myomectomy, patient discharge, Anesthesia Recovery Period
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal analgesic protocol during minimally invasive myomectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal analgesic protocol group | Experimental | Women who received the multimodal analgesic protocol during minimally invasive myomectomy. Receives: 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. Receives: Procedure: Multimodal analgesic protocol during minimally invasive myomectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main outcome measure is the Visual Analog Scale (VAS) score at 2 and 8 hours post surgery.
Measured: 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.
Measured: hours to few days after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2009 (estimated)
- Study startJan 2007
- Primary completionFeb 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iakentro Fertility Centre
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00978601
- Sponsor's protocol ID
- MULTI-LM-100
- Status last verified
- Sep 2009
- First submitted
- 15 Sep 2009
- Last updated
- 17 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1016/j.jmig.2007.08.608.
PubMed 18262139Prapas 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.
PubMed 19019334Hoffman 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.
PubMed 15904592Kehlet 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.
PubMed 17489225Xiromeritis 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.
PubMed 21806591
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Recovery Using Multimodal Peri-operative Analgesia in Minimally Invasive Myomectomy.A Randomized Study.
- ClinicalTrials.gov ID
- NCT00978601
- Acronym / sponsor ID
- MULTI-LM-100
- Conditions
- Anesthesia, Myomectomy
- Keywords
- post-operative analgesia, early discharge,, fast recovery,, minimally invasive myomectomy,, laparoscopy,, laparoscopically assisted myomectomy, patient discharge, Anesthesia Recovery Period
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Iakentro Fertility CentreUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 17 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal analgesic protocol group | Experimental | Procedure: Multimodal analgesic protocol during minimally invasive myomectomyWomen who received the multimodal analgesic protocol during minimally invasive myomectomy. |
| No use of multimodal analgesic protocol group | No intervention | Procedure: Multimodal analgesic protocol during minimally invasive myomectomyWomen who did not receive the multimodal analgesic protocol during minimally invasive myomectomy. |
Who may qualify
- Ages
- 20 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal analgesic protocol during minimally invasive myomectomyMultimodal 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. | Procedure or surgery | Multimodal analgesic protocol group, No use of multimodal analgesic protocol group |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2009.
- Background: PubMed 18262139de 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.
- Background: PubMed 19019334Prapas 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.
- Background: PubMed 15904592Hoffman 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.
- Background: PubMed 17489225Kehlet 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.
- Derived from this study: PubMed 21806591Xiromeritis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal analgesic protocol during minimally invasive myomectomy in people with Anesthesia and Myomectomy, run by Iakentro Fertility Centre at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00978601, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2009.