Ketamine With Multilevel Paravertebral Block for Post Video-assisted Thoracic Surgery Pain

Pain, Acute Clinical Trial

Official title:

Low Dose Intraoperative Intravenous Ketamine in Combination With Multilevel Paravertebral Block for Post Video-assisted Thoracic Surgery Pain: a Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03280017
• Other study ID #: 297/2560(EC1)
• Status: Completed
• Phase: Phase 4
• Start date: September 25, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: September 2022
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Postoperative pain after thoracic surgery is associated with adverse outcomes. The current strategy to prevent postoperative pain is the use of regional anesthesia and analgesic agents. In video-assisted thoracic surgery (VATS), thoracic paravertebral block has become the standard analgesic regimen which results in decreased postoperative pain and opioid consumption.

The investigator would like to study the analgesic efficacy of low dose intravenous ketamine infusion during surgery in combination with thoracic paravertebral block on postoperative pain after VATS in a randomized study.

Description:

Inadequate pain control after thoracic surgery is associated with adverse events such as postoperative pulmonary complications (PPC), and chronic post surgical pain.

Although the less invasive video-assisted thoracic surgery (VATS) has been used extensively as it produces optimal surgical outcomes and possible less postoperative pain, there are reports of inadequate pain control.

Thoracic paravertebral block (TPVB) has been introduced as an effective method in postoperative pain management after VATS. It is associated with improved pain control and the reduction of opioid analgesic consumption in several studies.

The use of intravenous low dose ketamine infusion during and after surgery has been shown to produce superior postoperative pain control in upper abdominal surgery and thoracotomy.

The aim of the present study is to study the efficacy of intravenous low dose ketamine infusion during surgery on acute and chronic pain after VATS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologist physical status 1-3

• Scheduled for elective video-assisted thoracic surgery

• Able to operate a patient-controlled analgesia device (PCA)

Exclusion Criteria:

• History of morphine allergy

• History of bupivacaine allergy

• Contraindication for ketamine infusion

• Contraindication for thoracic paravertebral block

• Anticipated postoperative positive pressure ventilation

• Body mass index more than 35

• Any known psychiatric disorder

Related Conditions & MeSH terms

• Acute Pain
• Chronic Pain
• Neuralgia
• Pain, Acute
• Pain, Chronic
• Pain, Neuropathic

Intervention

Drug:
• Ketamine
intravenous ketamine 0.2 mg/kg/hr (concentration 1 mg/ml)
• Normal saline
normal saline infusion

Locations

Country	Name	City	State
Thailand	Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (10)

Agostini P, Cieslik H, Rathinam S, Bishay E, Kalkat MS, Rajesh PB, Steyn RS, Singh S, Naidu B. Postoperative pulmonary complications following thoracic surgery: are there any modifiable risk factors? Thorax. 2010 Sep;65(9):815-8. doi: 10.1136/thx.2009.123083. — View Citation

Amlong C, Guy M, Schroeder KM, Donnelly MJ. Out-of-plane ultrasound-guided paravertebral blocks improve analgesic outcomes in patients undergoing video-assisted thoracoscopic surgery. Local Reg Anesth. 2015 Dec 15;8:123-8. doi: 10.2147/LRA.S86853. eCollection 2015. — View Citation

Bertrand PC, Regnard JF, Spaggiari L, Levi JF, Magdeleinat P, Guibert L, Levasseur P. Immediate and long-term results after surgical treatment of primary spontaneous pneumothorax by VATS. Ann Thorac Surg. 1996 Jun;61(6):1641-5. — View Citation

De Cosmo G, Aceto P, Gualtieri E, Congedo E. Analgesia in thoracic surgery: review. Minerva Anestesiol. 2009 Jun;75(6):393-400. Epub 2008 Oct 27. Review. — View Citation

Furrer M, Rechsteiner R, Eigenmann V, Signer C, Althaus U, Ris HB. Thoracotomy and thoracoscopy: postoperative pulmonary function, pain and chest wall complaints. Eur J Cardiothorac Surg. 1997 Jul;12(1):82-7. — View Citation

Gerner P. Postthoracotomy pain management problems. Anesthesiol Clin. 2008 Jun;26(2):355-67, vii. doi: 10.1016/j.anclin.2008.01.007. Review. — View Citation

Kaya FN, Turker G, Basagan-Mogol E, Goren S, Bayram S, Gebitekin C. Preoperative multiple-injection thoracic paravertebral blocks reduce postoperative pain and analgesic requirements after video-assisted thoracic surgery. J Cardiothorac Vasc Anesth. 2006 Oct;20(5):639-43. Epub 2006 Aug 8. — View Citation

Peng Z, Li H, Zhang C, Qian X, Feng Z, Zhu S. A retrospective study of chronic post-surgical pain following thoracic surgery: prevalence, risk factors, incidence of neuropathic component, and impact on qualify of life. PLoS One. 2014 Feb 28;9(2):e90014. doi: 10.1371/journal.pone.0090014. eCollection 2014. — View Citation

Suzuki M, Haraguti S, Sugimoto K, Kikutani T, Shimada Y, Sakamoto A. Low-dose intravenous ketamine potentiates epidural analgesia after thoracotomy. Anesthesiology. 2006 Jul;105(1):111-9. — View Citation

Wildgaard K, Ringsted TK, Hansen HJ, Petersen RH, Werner MU, Kehlet H. Quantitative sensory testing of persistent pain after video-assisted thoracic surgery lobectomy. Br J Anaesth. 2012 Jan;108(1):126-33. doi: 10.1093/bja/aer325. Epub 2011 Oct 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative morphine consumption	Amount of morphine (in milligrams) which is dispensed from a patient-controlled analgesia device (PCA)	24 hours postoperatively
Secondary	Time to first analgesia	Time period (in minutes) after the end of surgery until the time of first morphine solution is dispensed from PCA device	24 hours postoperatively
Secondary	Peak flow rates (day 1)	The value of peak flow velocity obtained from the first postoperative day will be compare with the value at the preoperative period	1 days
Secondary	Peak flow rates (day 2)	The value of peak flow velocity obtained from the first postoperative day will be compare with the value at the preoperative period	2 days
Secondary	Chronic post-surgical pain	The score of the Thai version of PainDetect questionnaire will be obtained at 1 month postoperatively	1 month
Secondary	Chronic post-surgical pain	The score of the Thai version of PainDetect questionnaire will be obtained at 3 months postoperatively	3 months