NCT03026543

Brief Summary

This prospective, blinded, randomized clinical trial investigates the effect on postoperative pain and nausea, when performing a ventilator-piloted PRM at the end of a laparoscopic cholecystectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

October 1, 2014

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 20, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

May 6, 2024

Status Verified

May 1, 2024

Enrollment Period

4.3 years

First QC Date

January 12, 2017

Last Update Submit

May 3, 2024

Conditions

Pain, PostoperativePostoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

  • Change in postoperative pain assessed with a numeric rating scale

    A questionnaire with a numeric rating scale (NRS) is used to assess pain intensity at 4, 12, 24, 36 and 48 hours postoperatively.

    4, 12, 24, 36 and 48 hours after surgery

Secondary Outcomes (1)

  • Change in postoperative nausea assessed with a Questionnaire

    4, 12, 24, 36 and 48 hours after surgery

Study Arms (2)

Pulmonary recruitment maneuver

EXPERIMENTAL

One minute of ventilator-piloted PRM at the end of laparoscopic cholecystectomy, intending to remove residual carbon dioxide (CO2) from the abdomen.

Procedure: Pulmonary Recruitment ManeuverProcedure: Laparoscopic cholecystectomyDevice: Ventilator

Control group

ACTIVE COMPARATOR

Ordinary ventilation at the end of laparoscopic cholecystectomy.

Procedure: Laparoscopic cholecystectomyDevice: Ventilator

Interventions

Pulmonary Recruitment ManeuverPROCEDURE
Pulmonary recruitment maneuver
Laparoscopic cholecystectomyPROCEDURE
Control groupPulmonary recruitment maneuver
VentilatorDEVICE
Control groupPulmonary recruitment maneuver

Eligibility Criteria

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

You may qualify if:

  • elective laparoscopic cholecystectomy
  • American Society of Anesthesiologists (ASA) physical status classification I-II (with the exception of body mass index over 35 kg/m2)
  • written consent

You may not qualify if:

  • conversion to open surgery
  • Clavien-Dindo grade ≥ II

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vrinnevi Hospital

Norrköping, Östergötland County, 603 79, Sweden

Location

Related Publications (1)

  • Kihlstedt Pasquier E, Andersson E. Pulmonary Recruitment Maneuver Reduces Shoulder Pain and Nausea After Laparoscopic Cholecystectomy: A Randomized Controlled Trial. World J Surg. 2021 Dec;45(12):3575-3583. doi: 10.1007/s00268-021-06262-6. Epub 2021 Sep 5.

    PMID: 34482412RESULT

MeSH Terms

Conditions

Pain, PostoperativePostoperative Nausea and Vomiting

Interventions

Cholecystectomy, LaparoscopicVentilators, Mechanical

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsNauseaSigns and Symptoms, DigestiveVomiting

Intervention Hierarchy (Ancestors)

CholecystectomyBiliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeLaparoscopyEndoscopyMinimally Invasive Surgical ProceduresEquipment and Supplies

Study Officials

  • Ebba Kihlstedt Pasquier, MD

    Vrinnevi Hospital, Norrköping, Sweden

    PRINCIPAL INVESTIGATOR

  • Ellen Andersson, MD, PhD

    Vrinnevi Hospital, Norrköping, Sweden

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 12, 2017

First Posted

January 20, 2017

Study Start

October 1, 2014

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

May 6, 2024

Record last verified: 2024-05

Locations

SE(1)