Regional Anesthesia Versus General Anesthesia

Not Applicable

Completed

• Conditions: Postoperative Pain; Anesthesia
• Interventions: Drug: Midazolam; Drug: Sufentanil; Drug: Bupivacaine; Drug: Propofol; Drug: Rocuronium; Drug: Sevoflurane

• Registration Number: NCT03830086
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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).

Study Timeline

• Study First Submitted: 2019-01-12
• Study First Submitted QC: 2019-02-04
• Study First Posted: 2019-02-05
• Study Start: 2019-02-07
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-12
• Last Update Posted: 2019-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

Inclusion Criteria

• patients undergoing gynecological laparoscopic surgery;
• expected surgical time shorter than 90 minutes;
• informed consent to participate in the study.

Exclusion Criteria

none.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A: general anesthesia	Midazolam	Patients undergoing gynecological laparoscopic surgery under general anesthesia, using the following drugs: Midazolam, Propofol, Sufentanil, Rocuronium, Sevoflurane
Group A: general anesthesia	Sufentanil	Patients undergoing gynecological laparoscopic surgery under general anesthesia, using the following drugs: Midazolam, Propofol, Sufentanil, Rocuronium, Sevoflurane
Group A: general anesthesia	Rocuronium	Patients undergoing gynecological laparoscopic surgery under general anesthesia, using the following drugs: Midazolam, Propofol, Sufentanil, Rocuronium, Sevoflurane
Group A: general anesthesia	Propofol	Patients undergoing gynecological laparoscopic surgery under general anesthesia, using the following drugs: Midazolam, Propofol, Sufentanil, Rocuronium, Sevoflurane
Group A: general anesthesia	Sevoflurane	Patients undergoing gynecological laparoscopic surgery under general anesthesia, using the following drugs: Midazolam, Propofol, Sufentanil, Rocuronium, Sevoflurane
Group B: regional anesthesia	Sufentanil	Patients undergoing gynecological laparoscopic surgery under regional anesthesia, using the following drugs: Sufentanil, Bupivacaine
Group B: regional anesthesia	Bupivacaine	Patients undergoing gynecological laparoscopic surgery under regional anesthesia, using the following drugs: Sufentanil, Bupivacaine

Primary Outcome Measures

Name	Time	Method
Feasibility and safety: Clavien-Dindo Classification (from Grade I to V)	From the surgery time, assessed up to 7 days after surgery	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

Name	Time	Method
Postoperative nausea or emesis.	48 hours after surgery	evaluation of the presence of postoperative nausea or emesis.
Days of hospitalization	From surgery to hospitalization discharge, assessed up to 7 days after surgery.	Number of days of hospitalization after surgery.
Day of mobilization.	From surgery to day of first mobilization, assessed up to 7 days after surgery.	Day of first mobilization after surgery.
Day of feeding.	From surgery to day of first feeding, assessed up to 7 days after surgery.	Day of first feeding after surgery.
Day of canalization.	From surgery to day of first canalization, assessed up to 7 days after surgery.	Day of first canalization after surgery.
Intraoperative pain: verbal numeric rating scale	Intraoperative: from skin incision to cutaneous suture.	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	Intraoperative: from skin incision to cutaneous suture.	Minimum respiratory rate during surgery.
End-Tidal PCO2 before pneumoperitoneum.	Intraoperative: from anesthesia to the beginning of pneumoperitoneum induction.	End-Tidal PCO2 is measured by capnography.
End-Tidal PCO2 during pneumoperitoneum.	Intraoperative: pneumoperitoneum time expressed in minutes.	End-Tidal PCO2 is measured by capnography.
Postoperative pain: numerical rating scale	48 hours after surgery	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

Trial Locations

Locations (2)

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