Lidocaine Infusion or Quadratus Lumborum Block and Intrathecal Morphine, Versus Intrathecal Morphine Alone

Stopped early · Early Phase 1 · Has a placebo group

Conditions studied: Gynecologic Cancer

In brief

This study may provide evidence for whether or not systemic lidocaine infusion offers significant advantage over truncal regional blocks in gynecology oncology surgery patients in terms of post-operative analgesia, recovery, and safety profile. Further, it may show whether there is any increased efficacy of adding truncal regional block or systemic lidocaine versus intrathecal opioid administration alone.

Key facts

Study ID

NCT03658109

Run by

University of Alabama at Birmingham

People needed

1

Starts

2019-09-24

Expected to finish

2021-05-04

Last updated by the study team

2021-05-10

Who can join

Age: 18 and older, up to 69. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Adult patients undergoing gynecologic-oncology surgery involving a mid-line laparotomy incision and as part of the local ERP, who are initially identified as an outpatient
• 18 years of age or older

You may not qualify if…

• Pregnancy,
• BMI>45,
• Age >70,
• Actual weight <65 kg
• Severe COPD
• Severe asthma
• Other severe respiratory disease (ILD, etc.)
• Local anesthetic allergy
• History of cardiac arrhythmia or heart block
• CHF
• Use of oral anti-arrhythmia agents or lidocaine analogues (i.e. mexiletine)
• Inability to be a candidate for intrathecal opioid injection based on medical history and provider judgement

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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