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NCT Number: NCT03830086

Regional Anesthesia Versus General Anesthesia

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.

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Key information

Conditions

Postoperative Pain Anesthesia Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cardiothoracic and Vascular Anesthesia and Intensive Care, S. OrsolaMalpighi University Hospital, Bologna, BO, Italy

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

none.

Treatment and study plan

midazolam

Drug

Used for general anesthesia for gynecological laparoscopic procedures, together with Propofol, Sufentanil, Rocuronium, Sevoflurane

Sufentanil

Drug

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

Drug

Used for general anesthesia for gynecological laparoscopic procedures, together with the following drugs: Midazolam, Sufentanil, Rocuronium, Sevoflurane

Rocuronium

Drug

Used for general anesthesia for gynecological laparoscopic procedures, together with the following drugs: Midazolam, Propofol, Sufentanil, Sevoflurane

Sevoflurane

Drug

Used for general anesthesia for gynecological laparoscopic procedures, together with the following drugs: Midazolam, Propofol, Sufentanil, Rocuronium

Bupivacaine

Drug

Used for regional anesthesia (spinal or combined spinal-epidural anesthesia) for gynecological laparoscopic procedures, together with Sufentanil

Primary outcomes

  1. Feasibility and safety: Clavien-Dindo Classification (from Grade I to V)

    Time frame: 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 outcomes

  1. Postoperative nausea or emesis.

    Time frame: 48 hours after surgery

    evaluation of the presence of postoperative nausea or emesis.

  2. Days of hospitalization

    Time frame: From surgery to hospitalization discharge, assessed up to 7 days after surgery.

    Number of days of hospitalization after surgery.

  3. Day of mobilization.

    Time frame: From surgery to day of first mobilization, assessed up to 7 days after surgery.

    Day of first mobilization after surgery.

  4. Day of feeding.

    Time frame: From surgery to day of first feeding, assessed up to 7 days after surgery.

    Day of first feeding after surgery.

  5. Day of canalization.

    Time frame: From surgery to day of first canalization, assessed up to 7 days after surgery.

    Day of first canalization after surgery.

  6. Intraoperative pain: verbal numeric rating scale

    Time frame: 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

  7. Minimum respiratory rate

    Time frame: Intraoperative: from skin incision to cutaneous suture.

    Minimum respiratory rate during surgery.

  8. End-Tidal PCO2 before pneumoperitoneum.

    Time frame: Intraoperative: from anesthesia to the beginning of pneumoperitoneum induction.

    End-Tidal PCO2 is measured by capnography.

  9. End-Tidal PCO2 during pneumoperitoneum.

    Time frame: Intraoperative: pneumoperitoneum time expressed in minutes.

    End-Tidal PCO2 is measured by capnography.

  10. Postoperative pain: numerical rating scale

    Time frame: 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

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

Regional Anesthesia Versus General Anesthesia in Patients Undergoing Laparoscopic Gynecological Surgery

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 5, 2019
Registry last updated
Jul 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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