We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Efficacy of Paravertebral and Epidural Analgesia After Videothoracoscopic Lung Lobectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02040662
First Posted: January 20, 2014
Last Update Posted: June 12, 2017
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.
Information provided by (Responsible Party):
Pulmonary Hospital Zakopane
  Purpose
Thoracic surgery correlates with significant pain in postoperative period. In order to alleviate the pain various combinations of pharmaceuticals and administration methods are employed. So as to reduce the extent of surgical trauma and, consequently, correlated pain various operation techniques are used. In traditional thoracotomy epidural anesthesia remains a golden standard. Epidural anesthesia however demands high skills to be performed correctly and presents an increased risk of grave complications. In videothoracoscopic (VATS) operations paravertebral blockade can be employed, yet there is no certainty if its efficacy after lung lobectomy. We therefore designed a prospective, randomized, parallel group, single site study to test the hypothesis, that continuous paravertebral blockade is as efficient in postoperative pain reduction as continuous epidural blockade and possesses a higher safety profile.

Condition Intervention Phase
Lung Cancer Procedure: Continuous Thoracic Epidural Block Procedure: Continuous Thoracic Paravertebral Block Procedure: Patient-Controlled Analgesia with Morphine Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Continuous Epidural and Continuous Paravertebral Blockade in Postoperative Analgesia After Videothoracoscopic Lung Lobectomy

Resource links provided by NLM:


Further study details as provided by Pulmonary Hospital Zakopane:

Primary Outcome Measures:
  • pain intensity measured in VAS in predetermined time intervals after the operation [ Time Frame: up to 96 hrs after the surgery ]

Secondary Outcome Measures:
  • respiratory parameters indirectly indicating conditions for efficient cough: peak expiratory flow (PEF), forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) [ Time Frame: up to 96 hrs after the surgery ]
  • frequency of side effects of regional anesthesia: urine retention resulting in necessity of bladder catheterization, hypotension, respiratory depression [ Time Frame: up to 96 hrs after surgery ]
  • frequency of respiratory complications: atelectasis or pneumonia [ Time Frame: up to 96 hrs after surgery ]
  • cumulative opioid (morphine) consumption [ Time Frame: up to 96 hrs after surgery ]

Enrollment: 120
Study Start Date: January 2013
Study Completion Date: July 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Continuous Thoracic Paravertebral Block
  1. continuous thoracic paravertebral blockade 0,08 ml/kg/h with bupivacaine 0,25% + epinephrine 1:200.000
  2. patient-controlled analgesia (morphine), bolus dose 2 mg, lockout time 10 min
Procedure: Continuous Thoracic Paravertebral Block
Before anesthesia, continuous thoracic paravertebral block of T5/T6 is performed (Portex Epidural Minipack set). Identification of paravertebral space by loss of resistance technique (normal saline). After injection of 5-10 ml of normal saline a catheter is advanced medially ca. 5 cm. At the end of surgery syringe with 0,25% bupivacaine with epinephrine 1:200.000 is connected to catheter and 20 ml bolus is injected, followed by an infusion of the same mixture at 0,08 ml/kg/h for postoperative pain management
Procedure: Patient-Controlled Analgesia with Morphine

Once arrived at the PACU all patients are placed on a postoperative analgesia regimen, that include:

  • patient-controlled analgesia with morphine (bolus dose 2 mg, lockout time 10 min)
  • paracetamol 1000 mg iv every 8 hrs
  • ketoprofen 100 mg iv every 12 hrs
Experimental: Continuous Thoracic Epidural Analgesia
  1. continuous thoracic epidural block 0,06 ml/kg/h with bupivacaine 0,25% + epinephrine 1:200.000
  2. patient-controlled analgesia (morphine), bolus dose 2 mg, lockout time 10 min
Procedure: Continuous Thoracic Epidural Block
Before anesthesia, continuous thoracic epidural block of T5/T6 is performed (Portex Epidural Minipack set). Identification of paravertebral space by loss of resistance technique (air). A catheter is advanced ca. 3-5 cm, and test dose with 2 ml of lidocaine 2% i injected. At the end of surgery syringe with 0,25% bupivacaine with epinephrine 1:200.000 is connected to catheter and 6 ml bolus is injected, followed by an infusion of the same mixture at 0,06 ml/kg/h for postoperative pain management.
Procedure: Patient-Controlled Analgesia with Morphine

Once arrived at the PACU all patients are placed on a postoperative analgesia regimen, that include:

  • patient-controlled analgesia with morphine (bolus dose 2 mg, lockout time 10 min)
  • paracetamol 1000 mg iv every 8 hrs
  • ketoprofen 100 mg iv every 12 hrs

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. American Society of Anesthesiologists (ASA) physical status 1-3
  2. undergo videothoracoscopic lung lobectomy
  3. forced expiratory volume in 1 second (FEV1) >1,5 l/min
  4. no contraindications for epidural anesthesia and paravertebral nerve blockade
  5. ability to comprehend principles of VAS pain examination method and to communicate in accordance with them.

Exclusion Criteria:

  1. prior to the study: contraindications for local anesthesia, ASA>3, FEV1<1,5 l/min, conditions disabling the patient from comprehending the principles of VAS pain examination, known allergy to used medications.
  2. during the study: failure to place epidural or paravertebral catheter, decision to abandon lobar resection (e.g. in case of neoplastic dissemination), intraoperative conversion to thoracotomy, intraoperative anatomical obstacles to distribution of local anesthetics, conditions disabling the patient from pain evaluation by means of VAS method (e.g. postoperative delirium), necessity to administer other pharmaceuticals influencing pain perception (e.g. sedatives), necessity of mechanical ventilation, interruption of local anesthesia as a result of technical problems (e.g. damage or slippage of catheter).
  Contacts and Locations
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): NCT02040662


Locations
Poland
Pulmonary Hospital
Zakopane, Poland, 34-500
Sponsors and Collaborators
Pulmonary Hospital Zakopane
  More Information

Responsible Party: Pulmonary Hospital Zakopane
ClinicalTrials.gov Identifier: NCT02040662     History of Changes
Other Study ID Numbers: 1/2014
First Submitted: January 13, 2014
First Posted: January 20, 2014
Last Update Posted: June 12, 2017
Last Verified: June 2017

Keywords provided by Pulmonary Hospital Zakopane:
paravertebral block
thoracic epidural analgesia
videothoracoscopic surgery
lung lobectomy

Additional relevant MeSH terms:
Bupivacaine
Morphine
Epinephrine
Racepinephrine
Epinephryl borate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents