Clinical trial NCT02684968: Effects of Continuous Bilateral QL Analgesia After Open Abdominal Surgery
Official title: The Effects of Continuous Bilateral Quadratus Lumborum Analgesia on Pain, Opioid Consumption, and Opioid-related Complications After Open Abdominal Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2016-02-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: local anesthetic continuous infusion (QL block + IV PCA group) or normal saline continuous infusion (IV PCA group).
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pain Score
timeFrame: The first postoperative pain score with 72 hours or until discharged using the VRS (0-10) scale
measure: Opioid Consumption
timeFrame: 72 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: General Anesthesiology
name: Wael Ali Sakr Esa, M.D.
role: PRINCIPAL_INVESTIGATOR
References: