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

NCT02040662 | Completed Phase 2

• 1 other identifier: 1/2014
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer

Keywords

paravertebral block; thoracic epidural analgesia; videothoracoscopic surgery; lung lobectomy

Outcome Measures

Primary Outcomes (1)

• pain intensity measured in VAS in predetermined time intervals after the operation

  up to 96 hrs after the surgery

Secondary Outcomes (4)

• respiratory parameters indirectly indicating conditions for efficient cough: peak expiratory flow (PEF), forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC)

  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

  up to 96 hrs after surgery

• frequency of respiratory complications: atelectasis or pneumonia

  up to 96 hrs after surgery

• cumulative opioid (morphine) consumption

  up to 96 hrs after surgery

Study Arms (2)

Continuous Thoracic Paravertebral Block

EXPERIMENTAL

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; Procedure: Patient-Controlled Analgesia with Morphine

Continuous Thoracic Epidural Analgesia

EXPERIMENTAL

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; Procedure: Patient-Controlled Analgesia with Morphine

Interventions

Continuous Thoracic Epidural Block PROCEDURE

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.

Continuous Thoracic Epidural Analgesia

Continuous Thoracic Paravertebral Block PROCEDURE

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

Continuous Thoracic Paravertebral Block

Patient-Controlled Analgesia with Morphine PROCEDURE

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

Continuous Thoracic Epidural Analgesia; Continuous Thoracic Paravertebral Block

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Pulmonary Hospital Zakopane: lead

Study Sites (1)

Pulmonary Hospital

Zakopane, 34-500, Poland

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Analgesia, Patient-Controlled; Morphine

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2014
• First Posted: January 20, 2014
• Study Start: January 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: June 12, 2017

Record last verified: 2017-06

Locations

PL (1)