The Comparison of the Analgesic Efficacy and Hemodynamic Effects of Paravertebral Block Compared With Paravertebral and Intercostal Nerve Block for Thoracotomy in Adults.
- Conditions
- Nerve BlockPain, PostoperativeThoracotomy
- Interventions
- Procedure: Paravertebral block/Intercostal Block (PVB/ICB) groupProcedure: Paravertebral Block (PVB) group
- Registration Number
- NCT04715880
- Lead Sponsor
- Aga Khan University Hospital, Pakistan
- Brief Summary
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
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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- All ASA I-IV adult patients between the ages of 18-70 years scheduled for elective thoracotomy
- Either sex
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Paravertebral block/Intercostal Block (PVB/ICB) group Paravertebral block/Intercostal Block (PVB/ICB) group 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. Paravertebral Block (PVB) group Paravertebral Block (PVB) group 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
- Primary Outcome Measures
Name Time Method Blood Pressure 24 hours Blood pressure in mmHg
Pain Score 24 hours Visual Analogue Scale (VAS) pain Score in cm (0cm = No pain and 10 cm= Worst pain possible)
Heart Rate 24 Hours Heart rate per minute
- Secondary Outcome Measures
Name Time Method Sedation score 24 hours 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
Total postoperative narcotic consumption 24 hours Patient controlled intravenous analgesia (PCIA) nalbuphine or Tramadol consumption in mg
Trial Locations
- Locations (1)
Aga Khan University Hospital
🇵🇰Karachi, Pakistan