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A Pain Study Comparing Two Commonly Used Medications to Treat Pain After Bowel Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02849678
Recruitment Status : Completed
First Posted : July 29, 2016
Results First Posted : February 24, 2017
Last Update Posted : March 20, 2018
Sponsor:
Collaborator:
University of Pittsburgh
Information provided by (Responsible Party):
Jacques E. Chelly, University of Pittsburgh

Brief Summary:

This research study is testing whether the local anesthetic lidocaine is as effective as ropivacaine for post-operative pain control in continuous thoracic paravertebral nerve blocks. Ropivacaine and Lidocaine are FDA-approved drugs that has been successfully used in this hospital for post-operative pain control for the past few years, thus has become the standard drugs used for this nerve block. Lidocaine has numerous potential advantages over ropivacaine, such as faster onset of action, better safety profile and greater anti-inflammatory action. Catheters placed near both sides of a patient's spine for postoperative pain control are called thoracic paravertebral nerve blocks and are a part of routine care. Through those catheters, a "numbing" medication, or local anesthetic, to block the transmission of pain from the surgical incision to the spinal cord, thus reducing pain. The research part of the study is whether subjects will receive either the local anesthetic lidocaine or ropivacaine. The goal of this study is to determine whether the lidocaine controls pain better and facilitates a faster recovery after abdominal surgery than ropivacaine.

In this research study, the investigators will compare patient-reported pain scores, any additional pain medication requirements for adequate pain control, time it takes for bowel function to return to normal following surgery, as well as the incidence of any side effects, such as numbness and weakness, subjects may experience between those receiving lidocaine versus those receiving ropivacaine. The investigators will screen 100 patients and enroll 60 subjects into this study.


Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Ropivacaine Drug: Lidocaine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Lidocaine Versus Ropivacaine for Bilateral Continuous Thoracic Paravertebral Nerve Blocks for Post-bowel Surgery Analgesia
Study Start Date : January 2008
Actual Primary Completion Date : November 2013
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Lidocaine

Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.

At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia.Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use.

Drug: Lidocaine

Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.

At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia. There are several studies to support this as listed in the references. Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use.

Other Name: Xylocaine

Active Comparator: Ropivacaine

Ropivacaine is a local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared.

Ropivacaine has been safely used in the paravertebral nerve blocks at our institution for several years.

Drug: Ropivacaine
0.5% Ropivacaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. It is the local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared.
Other Names:
  • Naropin®
  • Ropivacaine hydrochloride




Primary Outcome Measures :
  1. 11-point Verbal Numerical Rating Scale (NRS) Pain Assessment [ Time Frame: 24 hours from the end of surgery ]
    The primary outcome of the study is the NRS score for pain at rest at 24 hours. The NRS Pain Assessment requires patients to select a number between 0 - 10 where 0 is no pain and 10 is the worst imaginable pain. Patients pick one whole number on this scale to describe their pain.


Secondary Outcome Measures :
  1. Time to First Ambulation(Walking Greater Than 15 Feet) [ Time Frame: During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery) ]
    During the hospitalization following surgery until discharge. Hospital length of stay ranged from 3 - 22 days following surgery.

  2. Time to First Flatus/Defecation [ Time Frame: During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery) ]
    During the hospitalization following surgery until discharge. Hospital length of stay ranged from 3 - 22 days following surgery.

  3. Hospital Length of Stay. [ Time Frame: During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery) ]
    During the hospitalization following surgery until discharge. Hospital length of stay ranged from 3 - 22 days following surgery.

  4. Number of Patients With Complications (Including But Not Limited to Pneumonia, Atelectasis, Hypotension, Motor Weakness, Etc.) [ Time Frame: During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery) ]
    During the hospitalization following surgery until discharge.

  5. Postoperative Opioid Consumption (Milligrams of Dilaudid or Equivalent) [ Time Frame: During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery) ]
    During the hospitalization following surgery until discharge. Hospital length of stay ranged from 3 - 22 days following surgery.

  6. Consumption of Nerve Block Boluses Will Also be Recorded Daily [ Time Frame: During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery) ]
    During the hospitalization following surgery until discontinuation of the block or discharge. Hospital length of stay ranged from 3 - 22 days following surgery.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I-III subjects
  • Ages 18-80 years
  • Weight between 60 and 110 Kg
  • At least 60in (152cm) tall
  • Scheduled for elective open colonic surgery at UPMC Presbyterian Shadyside Hospital in Pittsburgh, Pennsylvania

Exclusion Criteria:

  • Age younger than 18 years or older than 80 years
  • Any contraindication to the placement of bilateral thoracic paravertebral catheters
  • American Society of Anesthesiologists physical status IV or greater
  • Chronic painful conditions
  • Preoperative opioid use
  • Coagulation abnormalities or patients who are expected to be on therapeutic anticoagulants postoperatively
  • Allergy to any of the drugs/agents used study protocol
  • Personal or family history of malignant hyperthermia
  • Serum creatinine greater than 1.3 g/dl
  • Pregnancy
  • Having an altered mental status (not oriented to place, person, or time)
  • Emergency surgery and those with sepsis, unstable angina, congestive heart disease, valvular heart disease, and severe COPD
  • Patient's inability to provide adequate informed consent
  • Non-english speaking
  • Patient refusal

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02849678


Locations
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United States, Pennsylvania
UPMC Presbyterian Shadyside
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
Jacques E. Chelly
University of Pittsburgh
Investigators
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Principal Investigator: Andrea Fanelli, MD University of Pittsburgh

Publications of Results:
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Responsible Party: Jacques E. Chelly, Vice Chair of Clinical Research, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02849678    
Other Study ID Numbers: PRO07080230
First Posted: July 29, 2016    Key Record Dates
Results First Posted: February 24, 2017
Last Update Posted: March 20, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: This data has been published.
Keywords provided by Jacques E. Chelly, University of Pittsburgh:
Postoperative Pain
Bowel Surgery
Regional Anesthesia
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Lidocaine
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action