Ketamine With Multilevel Paravertebral Block for Post Video-assisted Thoracic Surgery Pain
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|ClinicalTrials.gov Identifier: NCT03280017|
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : October 5, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Pain, Acute Pain, Chronic Pain, Neuropathic||Drug: Ketamine Drug: Normal saline||Phase 4|
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 (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Low Dose Intraoperative Intravenous Ketamine in Combination With Multilevel Paravertebral Block for Post Video-assisted Thoracic Surgery Pain: a Randomized Study|
|Actual Study Start Date :||September 25, 2017|
|Estimated Primary Completion Date :||September 30, 2019|
|Estimated Study Completion Date :||December 31, 2019|
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
intravenous ketamine 0.2 mg/kg/hr (concentration 1 mg/ml)
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
Drug: Normal saline
normal saline infusion
- Postoperative morphine consumption [ Time Frame: 24 hours postoperatively ]Amount of morphine (in milligrams) which is dispensed from a patient-controlled analgesia device (PCA)
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03280017
|Contact: Sirilak Suksompong, MDemail@example.com|
|Contact: Panop Limratana, MDfirstname.lastname@example.org|
|Bangkok, Thailand, 10700|
|Contact: Sirilak Suksompoong, MD email@example.com|
|Principal Investigator:||Sirilak Suksompong||Mahidol University|