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

Primary Purpose

Pain, Acute, Pain, Chronic, Pain, Neuropathic

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Ketamine
Normal saline
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Acute focused on measuring anesthesia, thoracic surgery, thoracic paravertebral block, ketamine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Siriraj Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ketamine

Normal saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
Chronic post-surgical pain
The score of the Thai version of PainDetect questionnaire will be obtained at 1 month postoperatively
Chronic post-surgical pain
The score of the Thai version of PainDetect questionnaire will be obtained at 3 months postoperatively

Full Information

First Posted
September 10, 2017
Last Updated
September 11, 2022
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT03280017
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 25, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Pain, Chronic, Pain, Neuropathic
Keywords
anesthesia, thoracic surgery, thoracic paravertebral block, ketamine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketamine
Arm Type
Experimental
Arm Description
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
Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
intravenous ketamine 0.2 mg/kg/hr (concentration 1 mg/ml)
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
normal saline infusion
Primary Outcome Measure Information:
Title
Postoperative morphine consumption
Description
Amount of morphine (in milligrams) which is dispensed from a patient-controlled analgesia device (PCA)
Time Frame
24 hours postoperatively
Secondary Outcome Measure Information:
Title
Time to first analgesia
Description
Time period (in minutes) after the end of surgery until the time of first morphine solution is dispensed from PCA device
Time Frame
24 hours postoperatively
Title
Peak flow rates (day 1)
Description
The value of peak flow velocity obtained from the first postoperative day will be compare with the value at the preoperative period
Time Frame
1 days
Title
Peak flow rates (day 2)
Description
The value of peak flow velocity obtained from the first postoperative day will be compare with the value at the preoperative period
Time Frame
2 days
Title
Chronic post-surgical pain
Description
The score of the Thai version of PainDetect questionnaire will be obtained at 1 month postoperatively
Time Frame
1 month
Title
Chronic post-surgical pain
Description
The score of the Thai version of PainDetect questionnaire will be obtained at 3 months postoperatively
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sirilak Suksompong
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18456219
Citation
Gerner P. Postthoracotomy pain management problems. Anesthesiol Clin. 2008 Jun;26(2):355-67, vii. doi: 10.1016/j.anclin.2008.01.007.
Results Reference
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PubMed Identifier
9262085
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. doi: 10.1016/s1010-7940(97)00105-x.
Results Reference
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PubMed Identifier
20805178
Citation
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.
Results Reference
background
PubMed Identifier
24587187
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.
Results Reference
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PubMed Identifier
21980121
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.
Results Reference
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PubMed Identifier
8651762
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. doi: 10.1016/0003-4975(96)00190-7.
Results Reference
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PubMed Identifier
18953284
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.
Results Reference
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PubMed Identifier
26730208
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.
Results Reference
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PubMed Identifier
17023279
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. doi: 10.1053/j.jvca.2006.03.022. Epub 2006 Aug 8.
Results Reference
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PubMed Identifier
16810002
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. doi: 10.1097/00000542-200607000-00020.
Results Reference
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Ketamine With Multilevel Paravertebral Block for Post Video-assisted Thoracic Surgery Pain

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