Postoperative PainNCT03830086
Regional Anesthesia Versus General Anesthesia
A study testing Midazolam, Sufentanil and Propofol in people with Postoperative Pain and Anesthesia, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Pain, Anesthesia
- What is being tested?
- Midazolam, Sufentanil and Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesItaly
- Study dates
- 7 Feb 2019to 30 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing gynecological laparoscopic surgery;
- expected surgical time shorter than 90 minutes;
- informed consent to participate in the study.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Cardiothoracic and Vascular Anesthesia and Intensive Care, S. OrsolaMalpighi University Hospital
Bologna, BO, 40138
Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital
Bologna, BO, 40138
About this study
Official title: Regional Anesthesia Versus General Anesthesia in Patients Undergoing Laparoscopic Gynecological Surgery
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.
Read the 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).
- Conditions
- Postoperative Pain, Anesthesia
- Being tested
- Midazolam, Sufentanil, Propofol, Rocuronium, Sevoflurane
- Keywords
- postoperative pain, regional anesthesia, general anesthesia, gynecological laparoscopy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Used for general anesthesia for gynecological laparoscopic procedures, together with Propofol, Sufentanil, Rocuronium, Sevoflurane
SufentanilDrug
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
PropofolDrug
Used for general anesthesia for gynecological laparoscopic procedures, together with the following drugs: Midazolam, Sufentanil, Rocuronium, Sevoflurane
RocuroniumDrug
Used for general anesthesia for gynecological laparoscopic procedures, together with the following drugs: Midazolam, Propofol, Sufentanil, Sevoflurane
SevofluraneDrug
Used for general anesthesia for gynecological laparoscopic procedures, together with the following drugs: Midazolam, Propofol, Sufentanil, Rocuronium
BupivacaineDrug
Used for regional anesthesia (spinal or combined spinal-epidural anesthesia) for gynecological laparoscopic procedures, together with Sufentanil
| Study group | Role | What they receive |
|---|---|---|
| Group A: general anesthesia | Other | Patients undergoing gynecological laparoscopic surgery under general anesthesia, using the following drugs: Midazolam, Propofol, Sufentanil, Rocuronium, Sevoflurane Receives: Drug: Midazolam; Drug: Sufentanil; Drug: Propofol; Drug: Rocuronium; Drug: Sevoflurane |
| Group B: regional anesthesia | Other | Patients undergoing gynecological laparoscopic surgery under regional anesthesia, using the following drugs: Sufentanil, Bupivacaine Receives: Drug: Sufentanil; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From the surgery time, assessed up to 7 days after surgery
Secondary outcomes (10)
Postoperative nausea or emesis.
evaluation of the presence of postoperative nausea or emesis.
Measured: 48 hours after surgery
Days of hospitalization
Number of days of hospitalization after surgery.
Measured: From surgery to hospitalization discharge, assessed up to 7 days after surgery.
Day of mobilization.
Day of first mobilization after surgery.
Measured: From surgery to day of first mobilization, assessed up to 7 days after surgery.
Day of feeding.
Day of first feeding after surgery.
Measured: From surgery to day of first feeding, assessed up to 7 days after surgery.
Day of canalization.
Day of first canalization after surgery.
Measured: 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
Measured: Intraoperative: from skin incision to cutaneous suture.
Minimum respiratory rate
Minimum respiratory rate during surgery.
Measured: Intraoperative: from skin incision to cutaneous suture.
End-Tidal PCO2 before pneumoperitoneum.
End-Tidal PCO2 is measured by capnography.
Measured: Intraoperative: from anesthesia to the beginning of pneumoperitoneum induction.
End-Tidal PCO2 during pneumoperitoneum.
End-Tidal PCO2 is measured by capnography.
Measured: 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
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start7 Feb 2019
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mabrouk, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830086
- Sponsor's protocol ID
- 160/2016/O/Oss
- Status last verified
- Jul 2019
- First submitted
- 12 Jan 2019
- Last updated
- 15 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Anesthesia Versus General Anesthesia in Patients Undergoing Laparoscopic Gynecological Surgery
- ClinicalTrials.gov ID
- NCT03830086
- Acronym / sponsor ID
- 160/2016/O/Oss
- Conditions
- Postoperative Pain, Anesthesia
- Keywords
- postoperative pain, regional anesthesia, general anesthesia, gynecological laparoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 7 Feb 2019 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 5 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: general anesthesia | Other | Drug: Midazolam, Drug: Sufentanil, Drug: Propofol, Drug: Rocuronium, Drug: SevofluranePatients undergoing gynecological laparoscopic surgery under general anesthesia, using the following drugs: Midazolam, Propofol, Sufentanil, Rocuronium, Sevoflurane |
| Group B: regional anesthesia | Other | Drug: Sufentanil, Drug: BupivacainePatients undergoing gynecological laparoscopic surgery under regional anesthesia, using the following drugs: Sufentanil, Bupivacaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients undergoing gynecological laparoscopic surgery;
- expected surgical time shorter than 90 minutes;
- informed consent to participate in the study.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MidazolamUsed for general anesthesia for gynecological laparoscopic procedures, together with Propofol, Sufentanil, Rocuronium, Sevoflurane | Drug | Group A: general anesthesia |
| SufentanilUsed 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 | Drug | Group A: general anesthesia, Group B: regional anesthesia |
| PropofolUsed for general anesthesia for gynecological laparoscopic procedures, together with the following drugs: Midazolam, Sufentanil, Rocuronium, Sevoflurane | Drug | Group A: general anesthesia |
| RocuroniumUsed for general anesthesia for gynecological laparoscopic procedures, together with the following drugs: Midazolam, Propofol, Sufentanil, Sevoflurane | Drug | Group A: general anesthesia |
| SevofluraneUsed for general anesthesia for gynecological laparoscopic procedures, together with the following drugs: Midazolam, Propofol, Sufentanil, Rocuronium | Drug | Group A: general anesthesia |
| BupivacaineUsed for regional anesthesia (spinal or combined spinal-epidural anesthesia) for gynecological laparoscopic procedures, together with Sufentanil | Drug | Group B: regional anesthesia |
Primary outcome
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)
10 secondary outcomes
Postoperative nausea or emesis.
Time frame: 48 hours after surgery
Days of hospitalization
Time frame: From surgery to hospitalization discharge, assessed up to 7 days after surgery.
Day of mobilization.
Time frame: From surgery to day of first mobilization, assessed up to 7 days after surgery.
Day of feeding.
Time frame: From surgery to day of first feeding, assessed up to 7 days after surgery.
Day of canalization.
Time frame: From surgery to day of first canalization, assessed up to 7 days after surgery.
Intraoperative pain: verbal numeric rating scale
Time frame: Intraoperative: from skin incision to cutaneous suture.
Minimum respiratory rate
Time frame: Intraoperative: from skin incision to cutaneous suture.
End-Tidal PCO2 before pneumoperitoneum.
Time frame: Intraoperative: from anesthesia to the beginning of pneumoperitoneum induction.
End-Tidal PCO2 during pneumoperitoneum.
Time frame: Intraoperative: pneumoperitoneum time expressed in minutes.
Postoperative pain: numerical rating scale
Time frame: 48 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
Related trials for Postoperative Pain
RecruitingPhase 4
Anrikefon-based Patient-controlled Intravenous Analgesia Following Laparoscopic Surgery
Laparoscopic Surgery, Visceral Pain, Postoperative
Recruiting
NOL Guided Analgesia During Elective Laparoscopic Surgery Under General Anesthesia
Intraoperative Analgesia
Recruiting
Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery
Postoperative Pain, Facial Swelling
Recruiting
Effect of Ultrasonic and Diode Laser Activated Irrigation on Postoperative Pain Following Root Canal Treatment
Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midazolam, Sufentanil and Propofol in people with Postoperative Pain and Anesthesia, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and safety: Clavien-Dindo Classification (from Grade I to V) (time frame: From the surgery time, assessed up to 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019.