NCT03830086

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2019

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 5, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

February 7, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

July 15, 2019

Status Verified

July 1, 2019

Enrollment Period

3 months

First QC Date

January 12, 2019

Last Update Submit

July 12, 2019

Conditions

Postoperative PainAnesthesia

Keywords

postoperative painregional anesthesiageneral anesthesiagynecological laparoscopy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Postoperative nausea or emesis.

    48 hours after surgery

  • Days of hospitalization

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

  • Day of mobilization.

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

  • Day of feeding.

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

  • Day of canalization.

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

  • +5 more secondary outcomes

Study Arms (2)

Group A: general anesthesia

OTHER

Patients undergoing gynecological laparoscopic surgery under general anesthesia, using the following drugs: Midazolam, Propofol, Sufentanil, Rocuronium, Sevoflurane

Drug: MidazolamDrug: SufentanilDrug: PropofolDrug: RocuroniumDrug: Sevoflurane

Group B: regional anesthesia

OTHER

Patients undergoing gynecological laparoscopic surgery under regional anesthesia, using the following drugs: Sufentanil, Bupivacaine

Drug: SufentanilDrug: Bupivacaine

Interventions

MidazolamDRUG

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

Group A: general anesthesia
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

Group A: general anesthesiaGroup B: regional anesthesia
PropofolDRUG

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

Group A: general anesthesia
RocuroniumDRUG

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

Group A: general anesthesia
SevofluraneDRUG

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

Group A: general anesthesia
BupivacaineDRUG

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

Group B: regional anesthesia

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Bologna, BO, 40138, Italy

Location

Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital

Bologna, BO, 40138, Italy

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

MidazolamSufentanilPropofolRocuroniumSevofluraneBupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsFentanylPiperidinesHeterocyclic Compounds, 1-RingPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsAndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, HalogenatedAnilidesAmidesAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 12, 2019

First Posted

February 5, 2019

Study Start

February 7, 2019

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

July 15, 2019

Record last verified: 2019-07

Locations

IT(2)