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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04715880
• Other study ID #: 2020-0797-7328
• Status: Completed
• Phase: N/A
• Start date: February 15, 2021
• Est. completion date: April 5, 2021

Study information

• Verified date: May 2021
• Source: Aga Khan University Hospital, Pakistan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 5, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• All ASA I-IV adult patients between the ages of 18-70 years scheduled for elective thoracotomy

• Either sex

Exclusion Criteria:

1. Neurological or psychiatric diseases

2. Emergency Procedures.

3. Language barrier

4. Patients under chronic treatment with opioids

5. Patients with hypersensitivity to bupivacaine

6. Coagulation disorders.

7. Unwilling to participate.

8. Patient previously involved in other studies

Related Conditions & MeSH terms

• Nerve Block
• Pain, Postoperative
• Thoracotomy

Intervention

Procedure:
• Paravertebral block/Intercostal Block (PVB/ICB) group
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
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

Locations

Country	Name	City	State
Pakistan	Aga Khan University Hospital	Karachi

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University Hospital, Pakistan

Country where clinical trial is conducted

Pakistan, 

References & Publications (2)

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. — View Citation

Yeung 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:CD009121. doi: 10.1002/14651858.CD009121.pub2. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Score	Visual Analogue Scale (VAS) pain Score in cm (0cm = No pain and 10 cm= Worst pain possible)	24 hours
Primary	Blood Pressure	Blood pressure in mmHg	24 hours
Primary	Heart Rate	Heart rate per minute	24 Hours
Secondary	Total postoperative narcotic consumption	Patient controlled intravenous analgesia (PCIA) nalbuphine or Tramadol consumption in mg	24 hours
Secondary	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