The Comparison of the Analgesic Efficacy and Hemodynamic Effects of Paravertebral Block Compared With Paravertebral and Intercostal Nerve Block for Thoracotomy in Adults.
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2021
CompletedFirst Posted
Study publicly available on registry
January 20, 2021
CompletedStudy Start
First participant enrolled
February 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 5, 2021
CompletedJune 2, 2021
May 1, 2021
2 months
January 15, 2021
May 30, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (2)
Total postoperative narcotic consumption
24 hours
Sedation score
24 hours
Study Arms (2)
Paravertebral Block (PVB) group
ACTIVE COMPARATORUnder 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
Paravertebral block/Intercostal Block (PVB/ICB) group
ACTIVE COMPARATORUnder 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.
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- All ASA I-IV adult patients between the ages of 18-70 years scheduled for elective thoracotomy
- Either sex
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aga Khan University Hospital
Karachi, Pakistan
Related Publications (3)
Perttunen K, Nilsson E, Heinonen J, Hirvisalo EL, Salo JA, Kalso E. Extradural, paravertebral and intercostal nerve blocks for post-thoracotomy pain. Br J Anaesth. 1995 Nov;75(5):541-7. doi: 10.1093/bja/75.5.541.
PMID: 7577277BACKGROUNDYeung JH, Gates S, Naidu BV, Wilson MJ, Gao Smith F. Paravertebral block versus thoracic epidural for patients undergoing thoracotomy. Cochrane Database Syst Rev. 2016 Feb 21;2(2):CD009121. doi: 10.1002/14651858.CD009121.pub2.
PMID: 26897642BACKGROUNDKumar S, Hameed M, Shehzad R, Samad K. The comparison of the analgesic efficacy of continuous paravertebral block alone compared with continuous paravertebral and intercostal nerve block for thoracotomy in adults: a randomized controlled trial. J Anesth. 2023 Dec;37(6):923-929. doi: 10.1007/s00540-023-03255-8. Epub 2023 Sep 25.
PMID: 37747499DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Trainee Medical Officer Anaesthesiology
Study Record Dates
First Submitted
January 15, 2021
First Posted
January 20, 2021
Study Start
February 15, 2021
Primary Completion
April 1, 2021
Study Completion
April 5, 2021
Last Updated
June 2, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share