Effects of Continuous Bilateral QL Analgesia After Open Abdominal Surgery

NCT02684968 | Completed

• 1 other identifier: 15-1273
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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.

  The first postoperative pain score with 72 hours or until discharged using the VRS (0-10) scale

• 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.

  72 hours after surgery

Study Arms (2)

Colorectal Surgery with QL block having anesthetic

EXPERIMENTAL

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

Procedure: Colorectal surgery

Colorectal Surgery with QL block having saline

PLACEBO COMPARATOR

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

Procedure: Colorectal surgery

Interventions

Colorectal surgery PROCEDURE

Colorectal Surgery with QL block having anesthetic; Colorectal Surgery with QL block having saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Wael Ali Sakr Esa, M.D.

  General Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: local anesthetic continuous infusion (QL block + IV PCA group) or normal saline continuous infusion (IV PCA group).

Study Record Dates

• First Submitted: February 11, 2016
• First Posted: February 18, 2016
• Study Start: March 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)