Continuous Paravertebral Block by Intraoperative Direct Access Versus Systemic Analgesia for Postthoracotomy Pain Relief

Post Thoracotomy Pain Clinical Trial

Official title:

Continuous Paravertebral Block by Intraoperative Direct Access Versus Systemic Analgesia for Postthoracotomy Pain Relief

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04482192
• Other study ID #: ZU-IRB: 6289
• Status: Completed
• Phase: Phase 3
• Start date: June 15, 2015
• Est. completion date: March 31, 2020

Study information

• Verified date: July 2020
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

to evaluate the safety and efficacy of continuous paravertebral block by intraoperative direct access on postthoracotomy pain compared to systemic analgesia.

Description:

Based on a pilot study of 20 participants, 10 in each group, the mean visual analogue score of pain at rest (VAS) ± Standard Deviation (SD) at 6 hours postoperatively for Thoracic paravertebral block group (TPVB) participants were 3.0 ± 1.4 and that for systemic analgesia (SA) participants were 4.2 ± 1.6. The calculated significant sample size with a power of 0.85 and alpha error of 0.05 was 60 participants, with 1:1 allocation in each group.

Eighty two participants were assessed for eligibility criteria to be included in the study, 18 participants were excluded pre-randomization, and one participant was excluded post-randomization due to re-exploration for bleeding. Sixty three participants were analyzed in the study. Thoracic paravertebral block group (TPVB group) included 32 participants and systemic analgesia group (SA group) included 31 participants.

Technique of intraoperative paravertebral catheter insertion:

The investigators used the technique that was described by Sabanathan et al in 1988[14] and modified by them in 1990 [15]. After completing the surgical pulmonary procedure and with the chest is still open, starting from the posterior end of the thoracotomy, parietal pleura is raised from the posterior chest wall to the vertebral body and for two spaces above and below the incision of thoracotomy creating a pouch. A 16-gauge disposable Tuohy needle is inserted percutaneously through a low posterior interspace. The needle is advanced until the tip appeared in the created pouch. The stylet is removed, and a 16-gauge side-holed epidural catheter is advanced into the created pouch and the needle is withdrawn. Using a curved forceps, a small defect is done in the extrapleural fascia to be directly in the paravertebral space. The cannula is passed to the paravertebral space through the defect and advanced cranially for 2 to 3 cm. The parietal pleura is reattached to the posterior edge of the wound and the catheter is secured. Then a bolus dose 15-20 ml of 1% lidocaine is injected through the catheter and the chest is closed as usual with one or two intercostal drainage tubes according to the surgical procedure.

Protocol of analgesia:

All participants, in both groups, received intravenous analgesia with 1gm paracetamol and 30 mg ketorolac half an hour before the end of surgery.

Systemic analgesia (SA) group continue to receive 1gm paracetamol and 30 mg ketorolac by intravenous infusion every 6 hours for 3 days. Thoracic paravertebral block (TPVB) group received continuous infusion of 0.1 ml/kg/h of 1.0% lidocaine (l mg/kg/h) using infusion pump through the inserted paravertebral catheter for 3 days. Intravenous morphine sulfate (0.05mg/kg) was given as a rescue medication if the VAS ≥ 4 for both groups. A senior nurse was responsible for handling the analgesia regimen and another nurse was responsible for recording pain score on visual analogue scale (VAS) and morphine consumption, as scheduled.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: March 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• • Elective posterolateral thoracotomy surgery

• American Society of Anesthesiologists (ASA) physical status of II and III

Exclusion Criteria:

• • lack of patient consent.

• patients younger than 18 years,

• emergency surgery,

• previous thoracotomy,

• drug addiction,

• allergy to paracetamol (acetaminophen) or ketorolac,

• coagulopathy,

• hepatic dysfunction,

• chronic renal failure,

• history of gastric ulcer

Related Conditions & MeSH terms

• Post Thoracotomy Pain

Intervention

Combination Product:
• Thoracic paravertebral block
After ending pulmonary procedure, a pleural pouch created beside vertebral column, a catheter is inserted to the pouch for continuous infusion of 1% lidocaine for 3 postoperative days. Intravenous morphine sulfate (0.05mg/kg) was given as a rescue medication if the VAS = 4.

Drug:
• Systemic analgesia
Systemic analgesia (SA) group receive 1gm paracetamol and 30 mg ketorolac by intravenous infusion every 6 hours for 3 days. Intravenous morphine sulfate (0.05mg/kg) was given as a rescue medication if the VAS = 4.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

References & Publications (8)

Batra RK, Krishnan K, Agarwal A. Paravertebral block. J Anaesthesiol Clin Pharmacol. 2011 Jan;27(1):5-11. — View Citation

Berrisford RG, Sabanathan SS. Direct access to the paravertebral space at thoracotomy. Ann Thorac Surg. 1990 May;49(5):854. — View Citation

Elia N, Lysakowski C, Tramèr MR. Does multimodal analgesia with acetaminophen, nonsteroidal antiinflammatory drugs, or selective cyclooxygenase-2 inhibitors and patient-controlled analgesia morphine offer advantages over morphine alone? Meta-analyses of r — View Citation

Fortier S, Hanna HA, Bernard A, Girard C. Comparison between systemic analgesia, continuous wound catheter analgesia and continuous thoracic paravertebral block: a randomised, controlled trial of postthoracotomy pain management. Eur J Anaesthesiol. 2012 N — View Citation

Katayama T, Hirai S, Kobayashi R, Hamaishi M, Okada T, Mitsui N. Safety of the paravertebral block in patients ineligible for epidural block undergoing pulmonary resection. Gen Thorac Cardiovasc Surg. 2012 Dec;60(12):811-4. doi: 10.1007/s11748-012-0149-5. — View Citation

Krakowski JC, Arora H. Con: Thoracic Epidural Block Is Not Superior to Paravertebral Blocks for Open Thoracic Surgery. J Cardiothorac Vasc Anesth. 2015 Dec;29(6):1720-2. doi: 10.1053/j.jvca.2015.06.012. Epub 2015 Jun 10. Review. — View Citation

Sabanathan S, Smith PJ, Pradhan GN, Hashimi H, Eng JB, Mearns AJ. Continuous intercostal nerve block for pain relief after thoracotomy. Ann Thorac Surg. 1988 Oct;46(4):425-6. — View Citation

Wojtys ME, Wasikowski J, Wójcik N, Wójcik J, Wasilewski P, Lisowski P, Grodzki T. Assessment of postoperative pain management and comparison of effectiveness of pain relief treatment involving paravertebral block and thoracic epidural analgesia in patient — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score on visual analogue scale (VAS) at rest	Paper-based visual analogue scale (VAS) is used for pain assessment. It provides a range of scores from 0-10. A higher score indicates greater pain intensity.	24 hours after operation
Primary	Pain score on visual analogue scale (VAS) on coughing	Paper-based visual analogue scale (VAS) is used for pain assessment. It provides a range of scores from 0-10. A higher score indicates greater pain intensity.	24 hours after operation
Secondary	Total morphine consumption	The summation of morphine consumption of the participant	end of first postoperative day
Secondary	Forced vital capacity (FVC)	measured by spirometer (Microspiro HI-298, Chest Corporation, Tokyo, Japan)	24 hours after operation
Secondary	Forced expiratory volume in 1s (FEV1)	measured by spirometer (Microspiro HI-298, Chest Corporation, Tokyo, Japan)	24 hours after operation
Secondary	Peak expiratory flow rate (PEFR)	measured by spirometer (Microspiro HI-298, Chest Corporation, Tokyo, Japan)	24 hours after operation

External Links

•   11. Rosenblatti M A, Lai Y, Thoracic nerve block techniques UpTo Date Topic 100071 Version 24.0, last updated: Jun 10, 2019.
•   Procedure specific postoperative pain management. (2015) Thoracotomy.