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

Aga Khan University Hospital, Pakistan

Status: Completed

Conditions: Thoracotomy; Nerve Block; Pain, Postoperative

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04715880

2020-0797-7328

Details and patient eligibility

About

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.

Full 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)

Enrollment: 70 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

Paravertebral Block (PVB) group

Active Comparator group

Description:

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

Treatment:

Procedure: Paravertebral Block (PVB) group

Paravertebral block/Intercostal Block (PVB/ICB) group

Active Comparator group

Description:

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.

Treatment:

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