Regional Anesthesia Versus General Anesthesia

Study Overview
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Brief Summary
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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
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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).

Official Title
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Regional Anesthesia Versus General Anesthesia in Patients Undergoing Laparoscopic Gynecological Surgery

Conditions
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Postoperative Pain, Anesthesia

Intervention / Treatment
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* Drug: Midazolam
* Drug: Sufentanil
* Drug: Propofol
* Drug: Rocuronium
* Drug: Sevoflurane
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing gynecological laparoscopic surgery; expected surgical time shorter than 90 minutes; informed consent to participate in the study. Exclusion Criteria: none.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group A: general anesthesia<br>Patients undergoing gynecological laparoscopic surgery under general anesthesia, using the following drugs: Midazolam, Propofol, Sufentanil, Rocuronium, Sevoflurane | Drug: Midazolam<br>* Used for general anesthesia for gynecological laparoscopic procedures, together with Propofol, Sufentanil, Rocuronium, Sevoflurane<br>Drug: Sufentanil<br>* 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<br>Drug: Propofol<br>* Used for general anesthesia for gynecological laparoscopic procedures, together with the following drugs: Midazolam, Sufentanil, Rocuronium, Sevoflurane<br>Drug: Rocuronium<br>* Used for general anesthesia for gynecological laparoscopic procedures, together with the following drugs: Midazolam, Propofol, Sufentanil, Sevoflurane<br>Drug: Sevoflurane<br>* Used for general anesthesia for gynecological laparoscopic procedures, together with the following drugs: Midazolam, Propofol, Sufentanil, Rocuronium<br>|
| Other: Group B: regional anesthesia<br>Patients undergoing gynecological laparoscopic surgery under regional anesthesia, using the following drugs: Sufentanil, Bupivacaine | Drug: Sufentanil<br>* 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<br>Drug: Bupivacaine<br>* Used for regional anesthesia (spinal or combined spinal-epidural anesthesia) for gynecological laparoscopic procedures, together with Sufentanil<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | From the surgery time, assessed up to 7 days after surgery | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative pain, regional anesthesia, general anesthesia, gynecological laparoscopy