Clinical trial NCT04715880: The Comparison of the Analgesic Efficacy and Hemodynamic Effects of Paravertebral Block Compared With Paravertebral and Intercostal Nerve Block for Thoracotomy in Adults.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Nerve Block
Thoracotomy
Lead sponsor: Aga Khan University Hospital, Pakistan
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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)

Eligibility criteria: 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

Primary outcomes:
measure: Pain Score
timeFrame: 24 hours
measure: Blood Pressure
timeFrame: 24 hours
measure: Heart Rate
timeFrame: 24 Hours
Secondary outcomes:
measure: Total postoperative narcotic consumption
timeFrame: 24 hours
measure: Sedation score
timeFrame: 24 hours
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University Hospital
Study officials:
References:
citation: 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.
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(2):CD009121. doi: 10.1002/14651858.CD009121.pub2.