An interventional study of Colorectal surgery in Pain, Postoperative, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-09.
Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Treatment
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 20 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.
Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.
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Exclusion Criteria:
Bilateral QL catheter with local anesthetic infusion + intravenous patient controlled narcotic medication
Procedure: Colorectal surgery
Bilateral QL catheter with normal saline infusion + intravenous patient controlled narcotic medication
Procedure: Colorectal surgery
Pain Score
primary hypothesis is that bilateral continuous QL local anesthetic infusion with IV PCA reduces total opioid consumption and/or time-weighted average pain scores during 72 hours after surgery compared to patients under IV PCA alone, and not worse on either outcome. In other words, IV PCA + QL block is superior to IV PCA alone, resulting in lower opioid consumption and/or less pain and not worse on either outcome.
Time frame: The first postoperative pain score with 72 hours or until discharged using the VRS (0-10) scale
Opioid Consumption
primary hypothesis is that bilateral continuous QL local anesthetic infusion with IV PCA reduces total opioid consumption and/or time-weighted average pain scores during 72 hours after surgery compared to patients under IV PCA alone, and not worse on either outcome.
Time frame: 72 hours after surgery
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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