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Completed

NCT Number: NCT02196727

Evaluation of Postoperative Pain Following Bascom Cleft Lift Operation

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hvidovre Univarsity Hospital

Hvidovre, Copenhagen, 2650, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 24 hours postoperatively

Secondary outcomes

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

    Time frame: 2 hours, 48 hours and 30 days postoperatively

Other outcomes

  1. Nausea

    Time frame: 2 hours postoperatively

    Scale (0= non, 1= mild, 2= moderate, 3= severe)

  2. Returning to work

    Time frame: 30 days

    Questionnaire: "Yes" or "No"

  3. Returning to leisure activities

    Time frame: 30 days

    Questionnaire: "Yes" or "No"

  4. Wound condition

    Time frame: 30 days

    Wound inspection for healing problems or infection

  5. Vomiting

    Time frame: 2 hours postoperatively

    Scale (0= non, 1= mild, 2= moderate, 3= severe)

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 22, 2014
Registry last updated
Jul 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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