Houston Methodist Hospital
Houston, Texas, 77030, United States
NCT Number: NCT06725485
The purpose of this study is to evaluate the safety and efficacy of lidocaine infusion in acute pain management following open abdominal surgery, including opiate use after surgery and the incidence of postoperative nausea and vomiting, Ileus, length of stays (ICU/hospital), and improvement in patient satisfaction.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Houston, Texas, 77030, United States
The management of acute pain remains challenging for the physicians, with many patients suffering from inadequate pain control following surgery. Evidence has shown that 90% of patients in the intensive care unit usually treated with opioids for pain. Poorly controlled pain and opioid-related adverse events have several negative consequences for critically ill patients during the postoperative period, including delay in functional recovery and hospital discharge, increased length of stay, development of chronic postsurgical pain, reduced patient satisfaction, and increased total healthcare cost. The reported incidence of postoperative Ileus varies with the procedure, ranging from 14.9% for large-bowel resection and 19.2% for small-bowel resection). Although many analgesic therapies are available, the high incidence of postoperative pain among patients indicates that there are still significant treatment challenges. Recently, there has been much interest in using low-dose lidocaine infusion for acute pain management in the operating room or/and PACU. Lidocaine is a drug with multiple effects, including anti-arrhythmic, local, topical, and injectable anesthetics. Lidocaine is also used for uncontrolled and chronic pain. However, this is an off-label use. Additionally, I.V. lidocaine is a potent anti-inflammatory, anti-hyperalgesic, and gastrointestinal pro-peristaltic drug. There is a lack of data on low dose lidocaine infusion for acute postoperative pain management in surgical critical care patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Low-dose lidocaine infusion 10-30 mcg/kg/min administered within 1 hour of ICU admission.
Time frame: Post-operative day 3
Opioid consumption in a 24-hour period starting 3 days after surgery, measured in morphine milligram equivalents
Time frame: Post-operative day 3
Patient numeric pain scale rating (0-10), with 0 being no pain and 10 being the worst pain possible
Time frame: Time of surgery through the end of post-operative day 3
The proportion of days post-surgery that the patient did not require opioid analgesia
Time frame: Time of surgery through discharge, up to 30 days
Post-operative day when patient first has a bowel movement
Time frame: Time of surgery through discharge, up to 30 days
Post-operative day number when patient returns to oral feeding
Time frame: Time of surgery through intensive care unit discharge, up to 1 year
Number of days between surgery and discharge from the intensive care unit after surgery
Time frame: Time of surgery through hospital discharge, up to 1 year
Number of days between surgery and discharge from hospital after surgery
The Methodist Hospital Research Institute
Other
Low-Dose Lidocaine Infusion for Acute Pain Management in the Surgical Intensive Care Unit - A Pilot Study
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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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