Regional Anesthesia Versus General Anesthesia

Postoperative Pain Clinical Trial

Official title:

Regional Anesthesia Versus General Anesthesia in Patients Undergoing Laparoscopic Gynecological Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03830086
• Other study ID #: 160/2016/O/Oss
• Status: Completed
• Phase: N/A
• Start date: February 7, 2019
• Est. completion date: April 30, 2019

Study information

• Verified date: July 2019
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients undergoing gynecological laparoscopic surgery;

• expected surgical time shorter than 90 minutes;

• informed consent to participate in the study.

Exclusion Criteria: none.

Related Conditions & MeSH terms

• Anesthesia
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Midazolam
Used for general anesthesia for gynecological laparoscopic procedures, together with Propofol, Sufentanil, Rocuronium, Sevoflurane
• Sufentanil
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
• Propofol
Used for general anesthesia for gynecological laparoscopic procedures, together with the following drugs: Midazolam, Sufentanil, Rocuronium, Sevoflurane
• Rocuronium
Used for general anesthesia for gynecological laparoscopic procedures, together with the following drugs: Midazolam, Propofol, Sufentanil, Sevoflurane
• Sevoflurane
Used for general anesthesia for gynecological laparoscopic procedures, together with the following drugs: Midazolam, Propofol, Sufentanil, Rocuronium
• Bupivacaine
Used for regional anesthesia (spinal or combined spinal-epidural anesthesia) for gynecological laparoscopic procedures, together with Sufentanil

Locations

Country	Name	City	State
Italy	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

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Country where clinical trial is conducted

Italy, 

Outcome

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