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

Improved Recovery Using Multimodal Peri-operative Analgesia in Minimally Invasive Myomectomy.A Randomized Study.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00978601

Enrollment

Registered

2009-09-17

Start date

2007-01-31

Completion date

2009-09-30

Last updated

2009-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Myomectomy

Keywords

post-operative analgesia, early discharge,, fast recovery,, minimally invasive myomectomy,, laparoscopy,, laparoscopically assisted myomectomy, patient discharge, Anesthesia Recovery Period

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)).

Interventions

PROCEDUREMultimodal 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 42 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026