Evaluation of Postoperative Pain Following Bascom Cleft Lift Operation

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02196727
• Other study ID #: BPP
• Status: Completed
• Phase: N/A
• First received: July 18, 2014
• Last updated: July 21, 2014
• Start date: May 2013
• Est. completion date: April 2014

Study information

• Verified date: May 2013
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The National Committee on Health Research Ethics
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Locations

Country	Name	City	State
Denmark	Hvidovre Univarsity Hospital	Hvidovre	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Nausea	Scale (0= non, 1= mild, 2= moderate, 3= severe)	2 hours postoperatively	No
Other	Returning to work	Questionnaire: "Yes" or "No"	30 days	No
Other	Returning to leisure activities	Questionnaire: "Yes" or "No"	30 days	No
Other	Wound condition	Wound inspection for healing problems or infection	30 days	No
Other	Vomiting	Scale (0= non, 1= mild, 2= moderate, 3= severe)	2 hours postoperatively	No
Primary	Numerical Rating Scale (NRS) pain score (0=no pain, 10= maximum imaginable pain)		24 hours postoperatively	No
Secondary	Numerical Rating Scale (NRS) pain score (0=no pain, 10= maximum imaginable pain)		2 hours, 48 hours and 30 days postoperatively	No