Trial record 13 of 635 for:    Open Studies | "Pain Management"

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

This study is currently recruiting participants.
Verified January 2014 by Pulmonary Hospital Zakopane
Sponsor:
Information provided by (Responsible Party):
Pulmonary Hospital Zakopane
ClinicalTrials.gov Identifier:
NCT02040662
First received: January 13, 2014
Last updated: January 15, 2014
Last verified: January 2014
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • frequency of respiratory complications: atelectasis or pneumonia [ Time Frame: up to 96 hrs after surgery ] [ Designated as safety issue: No ]
  • cumulative opioid (morphine) consumption [ Time Frame: up to 96 hrs after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2013
Estimated Study Completion Date: July 2014
Estimated 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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT02040662

Contacts
Contact: Sylweriusz Kosinski +48182015045 ext 207 kosa@mp.pl

Locations
Poland
Pulmonary Hospital Recruiting
Zakopane, Poland, 34-500
Contact: Sylweriusz Kosinski    +48182015045 ext 207    kosa@mp.pl   
Principal Investigator: Sylweriusz Kosinski         
Sponsors and Collaborators
Pulmonary Hospital Zakopane
  More Information

No publications provided

Responsible Party: Pulmonary Hospital Zakopane
ClinicalTrials.gov Identifier: NCT02040662     History of Changes
Other Study ID Numbers: 1/2014
Study First Received: January 13, 2014
Last Updated: January 15, 2014
Health Authority: Poland: Ethics Committee

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

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Morphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on April 16, 2014