Anesthesia, Postoperative Pain
Conditions
Keywords
postoperative pain, regional anesthesia, general anesthesia, gynecological laparoscopy
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).
Interventions
DRUGMidazolam
Used for general anesthesia for gynecological laparoscopic procedures, together with Propofol, Sufentanil, Rocuronium, Sevoflurane
DRUGSufentanil
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
DRUGPropofol
Used for general anesthesia for gynecological laparoscopic procedures, together with the following drugs: Midazolam, Sufentanil, Rocuronium, Sevoflurane
DRUGRocuronium
Used for general anesthesia for gynecological laparoscopic procedures, together with the following drugs: Midazolam, Propofol, Sufentanil, Sevoflurane
DRUGSevoflurane
Used for general anesthesia for gynecological laparoscopic procedures, together with the following drugs: Midazolam, Propofol, Sufentanil, Rocuronium
DRUGBupivacaine
Used for regional anesthesia (spinal or combined spinal-epidural anesthesia) for gynecological laparoscopic procedures, together with Sufentanil
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients undergoing gynecological laparoscopic surgery; * expected surgical time shorter than 90 minutes; * informed consent to participate in the study.
Exclusion criteria
none.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Postoperative nausea or emesis. | 48 hours after surgery | evaluation of the presence of postoperative nausea or emesis. |
| 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 |
| 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 |
Countries
Italy
Outcome results
None listed