Evaluation of Postoperative Pain Following Bascom Cleft Lift Operation

July 21, 2014 updated by: Saphana Jassim Mohamed, Hvidovre University Hospital

Evaluation of Post-operative Pain in Bascom Cleft Lift Operation Receiving Multimodal Analgesia and Spinal Saddle Block in Day Case Surgery Setting.

The purpose of this study is to evaluate postoperative pain in Bascom Cleft Lift operation receiving multimodal analgesia in day-case surgery setting.

Hypothesis: Multimodal analgesia provides adequate pain relief in patients undergoing Bascom Cleft Lift operation.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Copenhagen
      • Hvidovre, Copenhagen, Denmark, 2650
        • Hvidovre Univarsity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing Bascom Cleft Lift operation in a day-case surgery setting

Description

Inclusion Criteria:

  • Age > 18
  • ASA physical status 1 and 2
  • Patient undergoing Bascom operation in prone position

Exclusion Criteria:

  • Pregnancy
  • Current regular use of drug belonging to the class of opioids
  • Allergy/ intolerance to drugs included in multimodal analgesia regime

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Patients undergoing Bascom operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Numerical Rating Scale (NRS) pain score (0=no pain, 10= maximum imaginable pain)
Time Frame: 24 hours postoperatively
24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Numerical Rating Scale (NRS) pain score (0=no pain, 10= maximum imaginable pain)
Time Frame: 2 hours, 48 hours and 30 days postoperatively
2 hours, 48 hours and 30 days postoperatively

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nausea
Time Frame: 2 hours postoperatively
Scale (0= non, 1= mild, 2= moderate, 3= severe)
2 hours postoperatively
Returning to work
Time Frame: 30 days
Questionnaire: "Yes" or "No"
30 days
Returning to leisure activities
Time Frame: 30 days
Questionnaire: "Yes" or "No"
30 days
Wound condition
Time Frame: 30 days
Wound inspection for healing problems or infection
30 days
Vomiting
Time Frame: 2 hours postoperatively
Scale (0= non, 1= mild, 2= moderate, 3= severe)
2 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

July 18, 2014

First Submitted That Met QC Criteria

July 21, 2014

First Posted (Estimate)

July 22, 2014

Study Record Updates

Last Update Posted (Estimate)

July 22, 2014

Last Update Submitted That Met QC Criteria

July 21, 2014

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BPP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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