NCT02196727

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2013

Shorter than P25 for all trials

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

May 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 22, 2014

Completed
Last Updated

July 22, 2014

Status Verified

May 1, 2013

Enrollment Period

8 months

First QC Date

July 18, 2014

Last Update Submit

July 21, 2014

Conditions

Postoperative Pain

Keywords

Postoperative painMultimodal analgesiaBascom Cleft LiftDay-case.

Outcome Measures

Primary Outcomes (1)

  • Numerical Rating Scale (NRS) pain score (0=no pain, 10= maximum imaginable pain)

    24 hours postoperatively

Secondary Outcomes (1)

  • Numerical Rating Scale (NRS) pain score (0=no pain, 10= maximum imaginable pain)

    2 hours, 48 hours and 30 days postoperatively

Other Outcomes (5)

  • Nausea

    2 hours postoperatively

  • Returning to work

    30 days

  • Returning to leisure activities

    30 days

  • +2 more other outcomes

Study Arms (1)

Patients undergoing Bascom operation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre Univarsity Hospital

Hvidovre, Copenhagen, 2650, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 25557329DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

July 18, 2014

First Posted

July 22, 2014

Study Start

May 1, 2013

Primary Completion

January 1, 2014

Study Completion

April 1, 2014

Last Updated

July 22, 2014

Record last verified: 2013-05

Locations

DK(1)