Clinical trial NCT03830086: Regional Anesthesia Versus General Anesthesia
Official title: Regional Anesthesia Versus General Anesthesia in Patients Undergoing Laparoscopic Gynecological Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Anesthesia
Keywords: postoperative pain
regional anesthesia
general anesthesia
gynecological laparoscopy
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2019-02-05
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

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.

Primary outcomes:
measure: Feasibility and safety: Clavien-Dindo Classification (from Grade I to V)
timeFrame: From the surgery time, assessed up to 7 days after surgery
Secondary outcomes:
measure: Postoperative nausea or emesis.
timeFrame: 48 hours after surgery
measure: Days of hospitalization
timeFrame: From surgery to hospitalization discharge, assessed up to 7 days after surgery.
measure: Day of mobilization.
timeFrame: From surgery to day of first mobilization, assessed up to 7 days after surgery.
measure: Day of feeding.
timeFrame: From surgery to day of first feeding, assessed up to 7 days after surgery.
measure: Day of canalization.
timeFrame: From surgery to day of first canalization, assessed up to 7 days after surgery.
measure: Intraoperative pain: verbal numeric rating scale
timeFrame: Intraoperative: from skin incision to cutaneous suture.
measure: Minimum respiratory rate
timeFrame: Intraoperative: from skin incision to cutaneous suture.
measure: End-Tidal PCO2 before pneumoperitoneum.
timeFrame: Intraoperative: from anesthesia to the beginning of pneumoperitoneum induction.
measure: End-Tidal PCO2 during pneumoperitoneum.
timeFrame: Intraoperative: pneumoperitoneum time expressed in minutes.
measure: Postoperative pain: numerical rating scale
timeFrame: 48 hours after surgery
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Cardiothoracic and Vascular Anesthesia and Intensive Care, S. OrsolaMalpighi University Hospital
state: BO
city: Bologna
country: Italy
facility: Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital
state: BO
Study officials:
References: