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NCT02684968 · ClinicalTrials.gov registry record · NA

Effects of Continuous Bilateral QL Analgesia After Open Abdominal Surgery

A NA study, sponsored by The Cleveland Clinic.

Completed
Registry status
NA
Development phase
20
Enrollment target

NCT02684968: Completed NA study, sponsored by The Cleveland Clinic.

NCT02684968 is a NA study that has completed, run by The Cleveland Clinic. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02684968, a NA study, has completed, sponsored by The Cleveland Clinic.

COMPLETED
Registry status
NA
Development phase
20 participants
Enrollment target

Study Summary

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.

Primary Outcome

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.

Interventions

  • PROCEDURE Colorectal surgery

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2016-03
Est. Completion 2019-10
Phase NA
The Cleveland Clinic

688 total trials

What the finished NCT02684968 record still lists

NCT02684968 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Colorectal surgery is the first listed.

NCT02684968 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02684968 about?

NCT02684968 is a clinical study titled "Effects of Continuous Bilateral QL Analgesia After Open Abdominal Surgery". 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 ...

What is the current status of trial NCT02684968?

This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2016-03. Estimated completion is 2019-10.

What interventions are being tested in trial NCT02684968?

The interventions under investigation include: Colorectal surgery (PROCEDURE).

Who is sponsoring clinical trial NCT02684968?

This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02684968's enrollment target sits among peer trials

20 1768th of 2000 higher than 140 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02684968, the US trial registry maintained by the National Library of Medicine. NCT02684968 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.