The Comparison of the Analgesic Efficacy and Hemodynamic Effects of Paravertebral Block Compared With Paravertebral and Intercostal Nerve Block for Thoracotomy in Adults.

Study Overview
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Brief Summary
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Thoracotomy is a surgical procedure associated with severe post operative pain during the first day of surgery and is responsible for prolonged hospital stay, patient dissatisfaction and delayed return to normal activities along with increased morbidity and mortality. Investigators intend to compare the efficacy of two analgesic interventions (continuous infusion of paravertebral block (PVB) after loading dose compared with intercostal nerve block and continuous infusion of PVB without loading dose) on postoperative thoracotomy pain. The results of this study will direct the investigators to find the best practice methods which will reduce the postoperative thoracotomy pain, the overall cost of pain management and length of patient's hospital stay.

Detailed Description
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Objective To compare the safety, efficacy for pain relief and hemodynamic changes of two analgesic interventions(continuous infusion of Paravertebral block (PVB) after loading dose compared with intercostal nerve block and continuous infusion of PVB without loading dose)

Official Title
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The Comparison of the Analgesic Efficacy and Hemodynamic Effects of Paravertebral Block Compared With Paravertebral and Intercostal Nerve Block for Thoracotomy in Adults: A Randomized Controlled Trail

Conditions
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Pain, Postoperative, Nerve Block, Thoracotomy

Intervention / Treatment
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* Procedure: Paravertebral block/Intercostal Block (PVB/ICB) group
* Procedure: Paravertebral Block (PVB) group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All ASA I-IV adult patients between the ages of 18-70 years scheduled for elective thoracotomy Either sex Exclusion Criteria: Neurological or psychiatric diseases Emergency Procedures. Language barrier Patients under chronic treatment with opioids Patients with hypersensitivity to bupivacaine Coagulation disorders. Unwilling to participate. Patient previously involved in other studies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paravertebral Block (PVB) group<br>Under complete aseptic precaution, Patient will be in lateral decubitus position a paravertebral catheter will be placed by the surgeon before closure of thoracotomy wound. The catheter will be introduced percutaneously through 18 gauge needle into the pleural cavity. The tip of catheter will be loaded by anaesthesiologist with 0.25 % isobaric bupivacaine with 20 ml followed by continuous infusion with bupivacaine 0.25 % at 6-8 ml per hour | Procedure: Paravertebral Block (PVB) group<br>* A paravertebral catheter will be placed by the surgeon before closure of thoracotomy wound. The catheter will be introduced percutaneously through 18 gauge needle into the pleural cavity. The tip of catheter will be loaded by anaesthesiologist with 0.25 % isobaric bupivacaine with 20 ml followed by continuous infusion with bupivacaine 0.25 % at 6-8 ml per hour<br>|
| Active Comparator: Paravertebral block/Intercostal Block (PVB/ICB) group<br>Under complete aseptic precaution, patient will be in lateral decubitus position a paravertebral catheter will be placed by surgeon into pleural cavity and will not be loaded with bolus dose. At the end of surgery the (consultant anaesthesiologist) will perform intrathoracic unilateral intercostal nerve block two level above and two level below and at site of incision with 4 ml per level of 0.25 % bupivacaine followed by continuous infusion with 0.25 % bupivacaine at 6-8 ml/hour through catheter placed in paravertebral space. | Procedure: Paravertebral block/Intercostal Block (PVB/ICB) group<br>* A paravertebral catheter will be placed by surgeon into pleural cavity and will not be loaded with bolus dose. At the end of surgery the (consultant anaesthesiologist) will perform intrathoracic unilateral intercostal nerve block two level above and two level below and at site of incision with 4 ml per level of 0.25 % bupivacaine followed by continuous infusion with 0.25 % bupivacaine at 6-8 ml/hour through catheter placed in paravertebral space.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score | Visual Analogue Scale (VAS) pain Score in cm (0cm = No pain and 10 cm= Worst pain possible) | 24 hours | 
| Blood Pressure | Blood pressure in mmHg | 24 hours | 
| Heart Rate | Heart rate per minute | 24 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total postoperative narcotic consumption | Patient controlled intravenous analgesia (PCIA) nalbuphine or Tramadol consumption in mg | 24 hours | 
| Sedation score | Ramsay sedation scale: 1= anxious or restless, or both, 2 = Co-operative, oriented, and tranquil, 3 = Responding to commands, 4 = brisk response to stimulus, 5 = sluggish response to stimulus, 6 = no response to stimulus | 24 hours |