Clinical trial NCT03280017: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Acute
Pain, Chronic
Pain, Neuropathic
Keywords: anesthesia
thoracic surgery
thoracic paravertebral block
ketamine
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2017-09-12
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Postoperative morphine consumption
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Time to first analgesia
timeFrame: 24 hours postoperatively
measure: Peak flow rates (day 1)
timeFrame: 1 days
measure: Peak flow rates (day 2)
timeFrame: 2 days
measure: Chronic post-surgical pain
timeFrame: 1 month
measure: Chronic post-surgical pain
timeFrame: 3 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
affiliation: Mahidol University
name: Sirilak Suksompong
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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