Effects of Continuous Bilateral QL Analgesia After Open Abdominal Surgery

NeuroTherapia, Inc.

Status: Completed

Conditions: Pain, Postoperative

Treatments: Procedure: Colorectal surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT02684968

15-1273

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Colorectal Surgery with QL block having anesthetic

Experimental group

Description:

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

Treatment:

Procedure: Colorectal surgery

Colorectal Surgery with QL block having saline

Placebo Comparator group

Description:

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

Treatment:

Procedure: Colorectal surgery