Pain, AcutePhase 4NCT03280017
Ketamine With Multilevel Paravertebral Block for Post Video-assisted Thoracic Surgery Pain
A Phase 4 study testing Ketamine and Normal saline in people with Pain, Acute and Pain, Chronic, run by Mahidol University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain, Acute, Pain, Chronic, Pain, Neuropathic
- What is being tested?
- Ketamine and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteThailand
- Study dates
- 25 Sep 2017to 31 Dec 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologist physical status 1-3
- Scheduled for elective video-assisted thoracic surgery
- Able to operate a patient-controlled analgesia device (PCA)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low Dose Intraoperative Intravenous Ketamine in Combination With Multilevel Paravertebral Block for Post Video-assisted Thoracic Surgery Pain: a Randomized Study
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.
Read the 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.
- Conditions
- Pain, Acute, Pain, Chronic, Pain, Neuropathic
- Being tested
- Ketamine, Normal saline
- Keywords
- anesthesia, thoracic surgery, thoracic paravertebral block, ketamine
- Medical subject headings
- Acute Pain, Chronic Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
intravenous ketamine 0.2 mg/kg/hr (concentration 1 mg/ml)
Normal salineDrug
normal saline infusion
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Experimental | 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 Receives: Drug: Ketamine |
| Normal saline | Placebo comparator | 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 Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative morphine consumption
Amount of morphine (in milligrams) which is dispensed from a patient-controlled analgesia device (PCA)
Measured: 24 hours postoperatively
Secondary outcomes (5)
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
Measured: 24 hours postoperatively
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
Measured: 1 days
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
Measured: 2 days
Chronic post-surgical pain
The score of the Thai version of PainDetect questionnaire will be obtained at 1 month postoperatively
Measured: 1 month
Chronic post-surgical pain
The score of the Thai version of PainDetect questionnaire will be obtained at 3 months postoperatively
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start25 Sep 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sirilak Suksompong, Mahidol University
- Investigators
- Sirilak Suksompong, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03280017
- Sponsor's protocol ID
- 297/2560(EC1)
- Status last verified
- Sep 2022
- First submitted
- 10 Sep 2017
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gerner P. Postthoracotomy pain management problems. Anesthesiol Clin. 2008 Jun;26(2):355-67, vii. doi: 10.1016/j.anclin.2008.01.007.
PubMed 18456219Furrer 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.
PubMed 9262085Agostini 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.
PubMed 20805178Peng 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.
PubMed 24587187Wildgaard 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.
PubMed 21980121Bertrand 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.
PubMed 8651762De 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.
PubMed 18953284Amlong 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.
PubMed 26730208Kaya 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.
PubMed 17023279Suzuki 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.
PubMed 16810002
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Intraoperative Intravenous Ketamine in Combination With Multilevel Paravertebral Block for Post Video-assisted Thoracic Surgery Pain: a Randomized Study
- ClinicalTrials.gov ID
- NCT03280017
- Acronym / sponsor ID
- 297/2560(EC1)
- Conditions
- Pain, Acute, Pain, Chronic, Pain, Neuropathic
- Keywords
- anesthesia, thoracic surgery, thoracic paravertebral block, ketamine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 12 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Experimental | Drug: KetamineParticipant 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 |
| Normal saline | Placebo comparator | Drug: Normal salineParticipant 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologist physical status 1-3
- Scheduled for elective video-assisted thoracic surgery
- Able to operate a patient-controlled analgesia device (PCA)
Key exclusion criteria (7 listed)
- History of morphine allergy
- History of bupivacaine allergy
- Contraindication for ketamine infusion
- Contraindication for thoracic paravertebral block
- Anticipated postoperative positive pressure ventilation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamineintravenous ketamine 0.2 mg/kg/hr (concentration 1 mg/ml) | Drug | Ketamine |
| Normal salinenormal saline infusion | Drug | Normal saline |
Primary outcome
Postoperative morphine consumption
Time frame: 24 hours postoperatively
Amount of morphine (in milligrams) which is dispensed from a patient-controlled analgesia device (PCA)
5 secondary outcomes
Time to first analgesia
Time frame: 24 hours postoperatively
Peak flow rates (day 1)
Time frame: 1 days
Peak flow rates (day 2)
Time frame: 2 days
Chronic post-surgical pain
Time frame: 1 month
Chronic post-surgical pain
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Background: PubMed 18456219Gerner P. Postthoracotomy pain management problems. Anesthesiol Clin. 2008 Jun;26(2):355-67, vii. doi: 10.1016/j.anclin.2008.01.007.
- Background: PubMed 9262085Furrer 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.
- Background: PubMed 20805178Agostini 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.
- Background: PubMed 24587187Peng 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.
- Background: PubMed 21980121Wildgaard 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.
- Background: PubMed 8651762Bertrand 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.
- Background: PubMed 18953284De 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.
- Background: PubMed 26730208Amlong 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.
- Background: PubMed 17023279Kaya 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.
- Background: PubMed 16810002Suzuki 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sirilak Suksompong principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine and Normal saline in people with Pain, Acute and Pain, Chronic, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative morphine consumption (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03280017, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.