Back to resultsRegional Anesthesia Versus General Anesthesia
Primary Purpose
Postoperative Pain, Anesthesia
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Midazolam
Sufentanil
Propofol
Rocuronium
Sevoflurane
Bupivacaine
Sponsored by
About this trial
This is an interventional other trial for Postoperative Pain focused on measuring postoperative pain, regional anesthesia, general anesthesia, gynecological laparoscopy
Eligibility Criteria
Inclusion Criteria:
- patients undergoing gynecological laparoscopic surgery;
- expected surgical time shorter than 90 minutes;
- informed consent to participate in the study.
Exclusion Criteria: none.
Sites / Locations
- Cardiothoracic and Vascular Anesthesia and Intensive Care, S. OrsolaMalpighi University Hospital
- Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Group A: general anesthesia
Group B: regional anesthesia
Arm Description
Patients undergoing gynecological laparoscopic surgery under general anesthesia, using the following drugs: Midazolam, Propofol, Sufentanil, Rocuronium, Sevoflurane
Patients undergoing gynecological laparoscopic surgery under regional anesthesia, using the following drugs: Sufentanil, Bupivacaine
Outcomes
Primary Outcome Measures
Feasibility and safety: Clavien-Dindo Classification (from Grade I to V)
Evaluation of feasibility and safety of regional anesthesia for gynecological laparoscopic surgery, considering complications using Clavien-Dindo Classification (from Grade I to V)
Secondary Outcome Measures
Postoperative nausea or emesis.
evaluation of the presence of postoperative nausea or emesis.
Days of hospitalization
Number of days of hospitalization after surgery.
Day of mobilization.
Day of first mobilization after surgery.
Day of feeding.
Day of first feeding after surgery.
Day of canalization.
Day of first canalization after surgery.
Intraoperative pain: verbal numeric rating scale
Intraoperative pain in patients submitted to regional anesthesia (Group B), using a verbal numeric rating scale, from 0 to 10, where 0 is no pain and 10 is the worse pain ever
Minimum respiratory rate
Minimum respiratory rate during surgery.
End-Tidal PCO2 before pneumoperitoneum.
End-Tidal PCO2 is measured by capnography.
End-Tidal PCO2 during pneumoperitoneum.
End-Tidal PCO2 is measured by capnography.
Postoperative pain: numerical rating scale
Evaluation of postoperative pain in patients undergoing general or regional anesthesia for gynecological laparoscopic surgery, measured with verbal numerical rating scale, from 0 to 10, where 0 is no pain and 10 is the worse pain ever
Full Information
NCT ID
NCT03830086
First Posted
January 12, 2019
Last Updated
July 12, 2019
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1. Study Identification
Unique Protocol Identification Number
NCT03830086
Brief Title
Regional Anesthesia Versus General Anesthesia
Official Title
Regional Anesthesia Versus General Anesthesia in Patients Undergoing Laparoscopic Gynecological Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
February 7, 2019 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
April 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Patients undergoing laparoscopic gynecological surgery will receive regional anesthesia or general anesthesia with endotracheal intubation. The investigators aim to evaluate the feasibility and safety of regional anesthesia for laparoscopic gynecological procedures.
Detailed Description
Commonly, laparoscopic gynecological procedures are performed under general anesthesia with endotracheal intubation.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Anesthesia
Keywords
postoperative pain, regional anesthesia, general anesthesia, gynecological laparoscopy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A: general anesthesia
Arm Type
Other
Arm Description
Patients undergoing gynecological laparoscopic surgery under general anesthesia, using the following drugs: Midazolam, Propofol, Sufentanil, Rocuronium, Sevoflurane
Arm Title
Group B: regional anesthesia
Arm Type
Other
Arm Description
Patients undergoing gynecological laparoscopic surgery under regional anesthesia, using the following drugs: Sufentanil, Bupivacaine
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
Used for general anesthesia for gynecological laparoscopic procedures, together with Propofol, Sufentanil, Rocuronium, Sevoflurane
Intervention Type
Drug
Intervention Name(s)
Sufentanil
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
Used for general anesthesia for gynecological laparoscopic procedures, together with the following drugs: Midazolam, Sufentanil, Rocuronium, Sevoflurane
Intervention Type
Drug
Intervention Name(s)
Rocuronium
Intervention Description
Used for general anesthesia for gynecological laparoscopic procedures, together with the following drugs: Midazolam, Propofol, Sufentanil, Sevoflurane
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
Used for general anesthesia for gynecological laparoscopic procedures, together with the following drugs: Midazolam, Propofol, Sufentanil, Rocuronium
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
Used for regional anesthesia (spinal or combined spinal-epidural anesthesia) for gynecological laparoscopic procedures, together with Sufentanil
Primary Outcome Measure Information:
Title
Feasibility and safety: Clavien-Dindo Classification (from Grade I to V)
Description
Evaluation of feasibility and safety of regional anesthesia for gynecological laparoscopic surgery, considering complications using Clavien-Dindo Classification (from Grade I to V)
Time Frame
From the surgery time, assessed up to 7 days after surgery
Secondary Outcome Measure Information:
Title
Postoperative nausea or emesis.
Description
evaluation of the presence of postoperative nausea or emesis.
Time Frame
48 hours after surgery
Title
Days of hospitalization
Description
Number of days of hospitalization after surgery.
Time Frame
From surgery to hospitalization discharge, assessed up to 7 days after surgery.
Title
Day of mobilization.
Description
Day of first mobilization after surgery.
Time Frame
From surgery to day of first mobilization, assessed up to 7 days after surgery.
Title
Day of feeding.
Description
Day of first feeding after surgery.
Time Frame
From surgery to day of first feeding, assessed up to 7 days after surgery.
Title
Day of canalization.
Description
Day of first canalization after surgery.
Time Frame
From surgery to day of first canalization, assessed up to 7 days after surgery.
Title
Intraoperative pain: verbal numeric rating scale
Description
Intraoperative pain in patients submitted to regional anesthesia (Group B), using a verbal numeric rating scale, from 0 to 10, where 0 is no pain and 10 is the worse pain ever
Time Frame
Intraoperative: from skin incision to cutaneous suture.
Title
Minimum respiratory rate
Description
Minimum respiratory rate during surgery.
Time Frame
Intraoperative: from skin incision to cutaneous suture.
Title
End-Tidal PCO2 before pneumoperitoneum.
Description
End-Tidal PCO2 is measured by capnography.
Time Frame
Intraoperative: from anesthesia to the beginning of pneumoperitoneum induction.
Title
End-Tidal PCO2 during pneumoperitoneum.
Description
End-Tidal PCO2 is measured by capnography.
Time Frame
Intraoperative: pneumoperitoneum time expressed in minutes.
Title
Postoperative pain: numerical rating scale
Description
Evaluation of postoperative pain in patients undergoing general or regional anesthesia for gynecological laparoscopic surgery, measured with verbal numerical rating scale, from 0 to 10, where 0 is no pain and 10 is the worse pain ever
Time Frame
48 hours after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients undergoing gynecological laparoscopic surgery;
expected surgical time shorter than 90 minutes;
informed consent to participate in the study.
Exclusion Criteria: none.
Facility Information:
Facility Name
Cardiothoracic and Vascular Anesthesia and Intensive Care, S. OrsolaMalpighi University Hospital
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy
Facility Name
Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy
12. IPD Sharing Statement
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Regional Anesthesia Versus General Anesthesia
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