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
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COMPLETED
NA
28 participants
INTERVENTIONAL
2019-02-07
2019-04-30
Brief Summary
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Detailed Description
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The use of regional anesthesia in laparoscopy is reserved to patients declared unfit for general anesthesia because of severe comorbidities or it is applied in combination with general anesthesia to decrease postoperative pain.
Recently, growing literature evidence supports the use of regional anesthesia in patients undergoing laparoscopy.
The combination of minimally invasive surgery with regional anesthesia could increase the advantages of laparoscopic operations (less postoperative pain, shorter hospital stay, etc).
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Group A: general anesthesia
Patients undergoing gynecological laparoscopic surgery under general anesthesia, using the following drugs: Midazolam, Propofol, Sufentanil, Rocuronium, Sevoflurane
Midazolam
Used for general anesthesia for gynecological laparoscopic procedures, together with Propofol, Sufentanil, Rocuronium, Sevoflurane
Sufentanil
Used for regional anesthesia (spinal or combined spinal-epidural anesthesia) for gynecological laparoscopic procedures together with Bupivacaine; and for general anesthesia for gynecological laparoscopic procedures, together with following drugs: Midazolam, Propofol, Rocuronium, Sevoflurane
Propofol
Used for general anesthesia for gynecological laparoscopic procedures, together with the following drugs: Midazolam, Sufentanil, Rocuronium, Sevoflurane
Rocuronium
Used for general anesthesia for gynecological laparoscopic procedures, together with the following drugs: Midazolam, Propofol, Sufentanil, Sevoflurane
Sevoflurane
Used for general anesthesia for gynecological laparoscopic procedures, together with the following drugs: Midazolam, Propofol, Sufentanil, Rocuronium
Group B: regional anesthesia
Patients undergoing gynecological laparoscopic surgery under regional anesthesia, using the following drugs: Sufentanil, Bupivacaine
Sufentanil
Used for regional anesthesia (spinal or combined spinal-epidural anesthesia) for gynecological laparoscopic procedures together with Bupivacaine; and for general anesthesia for gynecological laparoscopic procedures, together with following drugs: Midazolam, Propofol, Rocuronium, Sevoflurane
Bupivacaine
Used for regional anesthesia (spinal or combined spinal-epidural anesthesia) for gynecological laparoscopic procedures, together with Sufentanil
Interventions
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Midazolam
Used for general anesthesia for gynecological laparoscopic procedures, together with Propofol, Sufentanil, Rocuronium, Sevoflurane
Sufentanil
Used for regional anesthesia (spinal or combined spinal-epidural anesthesia) for gynecological laparoscopic procedures together with Bupivacaine; and for general anesthesia for gynecological laparoscopic procedures, together with following drugs: Midazolam, Propofol, Rocuronium, Sevoflurane
Propofol
Used for general anesthesia for gynecological laparoscopic procedures, together with the following drugs: Midazolam, Sufentanil, Rocuronium, Sevoflurane
Rocuronium
Used for general anesthesia for gynecological laparoscopic procedures, together with the following drugs: Midazolam, Propofol, Sufentanil, Sevoflurane
Sevoflurane
Used for general anesthesia for gynecological laparoscopic procedures, together with the following drugs: Midazolam, Propofol, Sufentanil, Rocuronium
Bupivacaine
Used for regional anesthesia (spinal or combined spinal-epidural anesthesia) for gynecological laparoscopic procedures, together with Sufentanil
Eligibility Criteria
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Inclusion Criteria
* expected surgical time shorter than 90 minutes;
* informed consent to participate in the study.
18 Years
FEMALE
No
Sponsors
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IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER
Responsible Party
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Mohamed Mabrouk
Principal Investigator
Locations
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Cardiothoracic and Vascular Anesthesia and Intensive Care, S. OrsolaMalpighi University Hospital
Bologna, BO, Italy
Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital
Bologna, BO, Italy
Countries
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Other Identifiers
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160/2016/O/Oss
Identifier Type: -
Identifier Source: org_study_id
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