Effects of Continuous Bilateral QL Analgesia After Open Abdominal Surgery

NCT ID: NCT02684968

Last Updated: 2021-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2019-10-31

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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Colorectal Surgery with QL block having anesthetic

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

Group Type: EXPERIMENTAL

Colorectal surgery

Intervention Type: PROCEDURE

Colorectal Surgery with QL block having saline

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

Group Type: PLACEBO_COMPARATOR

Colorectal surgery

Intervention Type: PROCEDURE

Interventions

Colorectal surgery

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wael Ali Sakr Esa, M.D.

Role: PRINCIPAL_INVESTIGATOR

General Anesthesiology

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

15-1273

Identifier Type: -

Identifier Source: org_study_id