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

Not Applicable

Completed

• Conditions: Nerve Block; Pain, Postoperative; Thoracotomy

• 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)

Study Timeline

• Study First Submitted: 2021-01-15
• Study First Submitted QC: 2021-01-16
• Study First Posted: 2021-01-20
• Study Start: 2021-02-15
• Primary Completion: 2021-04-01
• Study Completion: 2021-04-05
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-30
• Last Update Posted: 2021-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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