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

• ClinicalTrials.gov Identifier: NCT03280017
• Recruitment Status: Unknown
• First Posted: September 12, 2017
• Last Update Posted: October 5, 2018
• Sponsor: Mahidol University
• Information provided by (Responsible Party): Sirilak Suksompong, Mahidol University

Tracking Information

• First Submitted Date: September 10, 2017
• First Posted Date: September 12, 2017
• Last Update Posted Date: October 5, 2018
• Actual Study Start Date: September 25, 2017
• Estimated Primary Completion Date: September 30, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 10, 2017)

Postoperative morphine consumption [ Time Frame: 24 hours postoperatively ]

Amount of morphine (in milligrams) which is dispensed from a patient-controlled analgesia device (PCA)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 10, 2017)

• Time to first analgesia [ Time Frame: 24 hours postoperatively ]
  Time period (in minutes) after the end of surgery until the time of first morphine solution is dispensed from PCA device
• Peak flow rates (day 1) [ Time Frame: 1 days ]
  The value of peak flow velocity obtained from the first postoperative day will be compare with the value at the preoperative period
• Peak flow rates (day 2) [ Time Frame: 2 days ]
  The value of peak flow velocity obtained from the first postoperative day will be compare with the value at the preoperative period
• Chronic post-surgical pain [ Time Frame: 1 month ]
  The score of the Thai version of PainDetect questionnaire will be obtained at 1 month postoperatively
• Chronic post-surgical pain [ Time Frame: 3 months ]
  The score of the Thai version of PainDetect questionnaire will be obtained at 3 months postoperatively

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

Brief 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.

Detailed 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.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

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

Intervention

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

Study Arms

• Experimental: Ketamine
  Participant allocated to this arm will receive intravenous ketamine infusion starting after the induction of anesthesia until the end of the surgery at the beginning of skin closure Participant will receive an ultrasound-guide thoracic paravertebral block using 0.5% plain bupivacaine prior to the induction of anesthesia
  Intervention: Drug: Ketamine
• Placebo Comparator: Normal saline
  Participant allocated to this arm will receive intravenous normal saline solution infusion starting after the induction of anesthesia until the end of the surgery at the beginning of skin closure Participant will receive an ultrasound-guide thoracic paravertebral block using 0.5% plain bupivacaine prior to the induction of anesthesia
  Intervention: Drug: Normal saline

Publications *

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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: September 10, 2017): 32
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2019
• Estimated Primary Completion Date: September 30, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Thailand

Administrative Information

• NCT Number: NCT03280017
• Other Study ID Numbers: 297/2560(EC1)
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Sirilak Suksompong, Mahidol University
• Study Sponsor: Mahidol University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Sirilak Suksompong; Mahidol University

• PRS Account: Mahidol University
• Verification Date: October 2018