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Effects of Continuous Bilateral QL Analgesia After Open Abdominal Surgery

NeuroTherapia, Inc. logo

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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