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

Pulmonary Hospital Zakopane

Status and phase: Completed; Phase 2

Conditions: Lung Cancer

Treatments: Procedure: Continuous Thoracic Paravertebral Block; Procedure: Continuous Thoracic Epidural Block; Procedure: Patient-Controlled Analgesia with Morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT02040662

1/2014

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Continuous Thoracic Paravertebral Block

Experimental group

Description:

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

Treatment:

Procedure: Patient-Controlled Analgesia with Morphine

Procedure: Continuous Thoracic Paravertebral Block

Continuous Thoracic Epidural Analgesia

Experimental group

Description:

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

Treatment:

Procedure: Patient-Controlled Analgesia with Morphine

Procedure: Continuous Thoracic Epidural Block