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

Phase 2

Completed

• Conditions: Lung Cancer
• Interventions: Procedure: Continuous Thoracic Paravertebral Block; Procedure: Continuous Thoracic Epidural Block; Procedure: Patient-Controlled Analgesia with Morphine

• Registration Number: NCT02040662
• Lead Sponsor: Pulmonary Hospital Zakopane

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-01-13
• Study First Submitted QC: 2014-01-15
• Study First Posted: 2014-01-20
• Primary Completion: 2014-06
• Study Completion: 2014-07
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-09
• Last Update Posted: 2017-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous Thoracic Paravertebral Block	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
Continuous Thoracic Paravertebral Block	Patient-Controlled Analgesia with Morphine	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
Continuous Thoracic Epidural Analgesia	Continuous Thoracic Epidural Block	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
Continuous Thoracic Epidural Analgesia	Patient-Controlled Analgesia with Morphine	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

Primary Outcome Measures

Name	Time	Method
pain intensity measured in VAS in predetermined time intervals after the operation	up to 96 hrs after the surgery

Secondary Outcome Measures

Name	Time	Method
frequency of respiratory complications: atelectasis or pneumonia	up to 96 hrs after surgery
cumulative opioid (morphine) consumption	up to 96 hrs after surgery
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

Trial Locations

Locations (1)

Pulmonary Hospital; 🇵🇱 Zakopane, Poland