Evaluation of Postoperative Pain Following Bascom Cleft L... | NCT02196727

Studies
Evaluation of Postoperative Pain Following Bascom Cleft Lift Operation

NCT02196727

Sponsor

Hvidovre University Hospital

Status

Completed

Last Update Posted

Jul 22, 2014Estimated

Enrollment

32Actual

Phase

Not provided

Conditions

Postoperative Pain

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013

Primary Completion Date

Jan 2014Actual

Completion Date

Apr 2014Actual

First Submitted Date

Jul 18, 2014

First Submission Date that Met QC Criteria

Jul 21, 2014

First Posted Date

Jul 22, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 21, 2014

Last Update Posted Date

Jul 22, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Label	Type	Description	Intervention Names
Patients undergoing Bascom operation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Measure	Description	Time Frame
Nausea	Scale (0= non, 1= mild, 2= moderate, 3= severe)	2 hours postoperatively
Returning to work	Questionnaire: "Yes" or "No"	30 days

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hvidovre Univarsity Hospital		Hvidovre	Copenhagen	2650	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25557329	Derived	Mohamed SJ, Kristensen BB, Lindgaard L, Bisgaard T. Acceptable effect of multimodal analgesic treatment after a Bascom cleft lift operation. Dan Med J. 2015 Jan;62(1):A4985.

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain