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

NCT ID: NCT02040662

Last Updated: 2017-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Continuous Thoracic Paravertebral Block

Intervention Type: 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

Patient-Controlled Analgesia with Morphine

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Continuous Thoracic Epidural Block

Intervention Type: 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.

Patient-Controlled Analgesia with Morphine

Intervention Type: 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

Interventions

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.

Intervention Type: 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

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pulmonary Hospital Zakopane

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Pulmonary Hospital

Zakopane, , Poland

Countries

Poland

Other Identifiers

1/2014

Identifier Type: -

Identifier Source: org_study_id