Effects of Continuous Bilateral QL Analgesia After Open Abdominal Surgery

Completed · Not applicable

Conditions studied: Pain, Postoperative

In brief

Eligible patients will be randomized 1:1 without stratification to bilateral continuous QL catheters with local anesthetic continuous infusion (QL block + IV patient-controlled analgesia group) or normal saline continuous infusion (IV patient-controlled analgesia group). In the postanesthesia care unit (PACU), patients will be given intravenous boluses of hydromorphone or fentanyl as needed. Following immediate recovery from anesthesia, patients will be provided with a hydromorphone IV patient-controlled analgesia pump with standard initial settings and an option of clinician dose for breakthrough pain. IV patient-controlled hydromorphone pump settings will be titrated to comfort level (pain score\<4) by blinded clinicians. Each of the catheters will be connected to patient controlled infusion pump running at a basal rate of 6mL/hour of 0.1% Bupivacaine or normal saline with on-demand bolus of 5 mL every 60 minutes to be started in the operating room before the surgical incision. Opioid consumption first 72 hours or until discharge, whichever comes first will be recorded. Pain scores during first 72 hours or until discharge, whichever comes first will be recorded with a verbal rating scale and obtained from the patient's electronic medical records. The morning of post operative day 1 and post operative day 3 the ORSDS and QOR surveys will be completed. Morning of the day of discharge, the overall patient satisfaction with pain management survey will be completed.

Key facts

Study ID

NCT02684968

Run by

The Cleveland Clinic

People needed

20

Starts

2016-03-01

Expected to finish

2019-10-01

Last updated by the study team

2021-02-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults scheduled for elective colorectal surgery with a midline incision;
• American Society of Anesthesiologists (ASA) physical status 1-3.

You may not qualify if…

• Contraindication or intolerance to opioids and/or local anesthetics;
• Inability to use IV PCA system;
• History of chronic pain defined as use of opioids for more than 30 consecutive days within the 3 preoperative months at the dose equal or greater than equivalent of 15 mg of morphine and/or abdominal pain for more than 6 months, present most days of the weeks;
• History of neurological illness and/or neuropathy - Peripheral neuropathy, paralysis;
• Pregnancy and/or breastfeeding;
• Chronic renal failure, defined by estimated GFR <60 ml/min;
• Chronic liver failure, defined by cirrhosis, portal hypertension, or history of variceal bleeding.
• BMI > 35

Where it is running

• Cleveland Clinic — Cleveland, Ohio, United States

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