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Effects of Continuous Bilateral QL Analgesia After Open Abdominal Surgery

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Colorectal surgery
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Colorectal Surgery with QL block having anesthetic

Colorectal Surgery with QL block having saline

Arm Description

Bilateral QL catheter with local anesthetic infusion + intravenous patient controlled narcotic medication

Bilateral QL catheter with normal saline infusion + intravenous patient controlled narcotic medication

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 11, 2016
Last Updated
February 8, 2021
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02684968
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
October 2019 (Actual)
Study Completion Date
October 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
local anesthetic continuous infusion (QL block + IV PCA group) or normal saline continuous infusion (IV PCA group).
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Colorectal Surgery with QL block having anesthetic
Arm Type
Experimental
Arm Description
Bilateral QL catheter with local anesthetic infusion + intravenous patient controlled narcotic medication
Arm Title
Colorectal Surgery with QL block having saline
Arm Type
Placebo Comparator
Arm Description
Bilateral QL catheter with normal saline infusion + intravenous patient controlled narcotic medication
Intervention Type
Procedure
Intervention Name(s)
Colorectal surgery
Primary Outcome Measure Information:
Title
Pain Score
Description
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
Title
Opioid Consumption
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wael Ali Sakr Esa, M.D.
Organizational Affiliation
General Anesthesiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Continuous Bilateral QL Analgesia After Open Abdominal Surgery

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