Clinical trial NCT02619513: Effects of Dexmedetomidine Used in Continuous Thoracic Paravertebral Blocks
Official title: Effects of Dexmedetomidine as an Adjunctive Analgesic Used in Continuous Thoracic Paravertebral Blocks for Post-thoracotomy Pain Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-thoracotomy Pain Syndrome
Keywords: Paravertebral Blocks
Dexmedetomidine
Analgesia
Inflammatory response
Thoracotomy
Lead sponsor: Guangzhou General Hospital of Guangzhou Military Command
Sponsor class: OTHER
First posted: 2015-12-02
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to explore the effectiveness of dexmedetomidine as an adjunctive analgesic, used in ultrasound-guided continuous thoracic paravertebral blocks for Post-thoracotomy Pain Syndrome(PTPS).

Detailed description: Thoracic surgical procedures are among the most painful operations, and their outcomes are affected adversely by postoperative discomfort. Post-thoracotomy pain syndrome (PTPS) is a well-recognized complication of thoracotomy. Post-thoracotomy pain control improves patient satisfaction and decreases postoperative complication morbidity. Epidural analgesia used to be considered as the best method of pain relief after major surgery despite its side-effects, which includes hypotension, respiratory depression, incomplete or failed block, etc. Recently, paravertebral block is an alternative technique that may offer a comparable analgesic effect and a better side-effect profile for post-thoracotomy pain. Dexmedetomidine(DEX) is a Food and Drug Administration-approved, parenteral, selective α2-agonist that induces anxiolytic and analgesia without respiratory depression. It could provide dose-dependent sedation , analgesia , anti-anxiety and inhibition of sympathetic nerves and other effects . Current studies with regard to the effectiveness of DEX as an adjunctive medicine, used in ultrasound-guided continuous thoracic paravertebral blocks for PTPS. The mechanical withdrawal threshold and VAS scores are recorded. The consumption of opioid and general anesthetics during perioperative period are also recorded. To compare the incidence rates of side effects, such as nausea, vomiting, dizziness, hypotension and bradyarrhythmia in the first 3 days after operation among the groups.Also,to measure and compare the level of inflammatory factor in different group.A questionnaire is adopted to investigate whether there are chronic pain symptoms happen at 6 months after the operation which aim to PTPS.

Eligibility criteria: Inclusion Criteria:

1. ASA Ⅰ～Ⅲ patient undergoing thoracotomy;
2. Written informed consent from the patient or the relatives of the participating patient.
3. BMI:18～25kg/m2

Exclusion Criteria:

1. Mental illness;
2. Epidural anesthesia or thoracic paravertebral blocks contraindicated;
3. People who have Slow-type arrhythmias or hypotension;
4. People who have lung infection or sleep apnea syndrome;
5. People who have chronic renal failure;
6. Alcohol or drug abuse;
7. Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug;
8. Local anesthetics allergy;

Primary outcomes:
measure: Baseline mechanical withdrawal threshold(unit: g) of patients without treatment-related events.
timeFrame: the day before the operation
measure: The change of mechanical withdrawal threshold(unit: g) of patients with different treatment-related events in the following one week after thoracotomy.
timeFrame: 12, 24, 48, 72h and 1w after the operation
measure: The change of Interleukin-6(IL-6) of patients with different treatment-related events during the perioperative period.
timeFrame: pre-operation and 6, 24, 72h after the operation
measure: The change of Interleukin-10(IL-10) of patients with different treatment-related events during the perioperative period.
timeFrame: pre-operation and 6, 24, 72h after the operation
measure: The change of tumor necrosis factor-α(TNF-α) of patients with different treatment-related events during the perioperative period.
timeFrame: pre-operation and 6, 24, 72h after the operation
Secondary outcomes:
measure: The change of visual analogue scale(VAS) of patients with different treatment-related events in the following one week after thoracotomy.
timeFrame: 12, 24, 48, 72h and 1w after the operation
measure: The intraoperative consumption of opioids.
timeFrame: From the beginning to the end of the anesthesia procedure.
measure: The postoperative consumption of opioids.
timeFrame: in the first 3 days after operation
measure: The change of mean arterial pressure (MAP) of the patients when receiving the thoracotomy.
timeFrame: the key time have been distributed into five parts: when the patient was brought to the operation room (T0), 15 mins after paravertebral administration (T1), after intubation (T2), after skin incision (T3), before extubation (T4)
measure: The change of heart rate(HR) of the patients when receiving the thoracotomy.
timeFrame: the key time have been distributed into five parts: when the patient was brought to the operation room (T0), 15 mins after paravertebral administration (T1), after intubation (T2), after skin incision (T3), before extubation (T4)
measure: The incidence rates of side effects.
timeFrame: in the first 3 days after operation
measure: A questionnaire related to postoperation chronic for the patients who have receiving thoracotomy.
timeFrame: at 6 months after operation
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Anesthesiology，Guangzhou Military Region General Hospital
state: Guangdong
Study officials:
affiliation: Guangzhou General Hospital of Guangzhou Military Command
name: Jie Peng, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ding X, Jin S, Niu X, Ren H, Fu S, Li Q. A comparison of the analgesia efficacy and side effects of paravertebral compared with epidural blockade for thoracotomy: an updated meta-analysis. PLoS One. 2014 May 5;9(5):e96233. doi: 10.1371/journal.pone.0096233. eCollection 2014.
citation: Komatsu T, Sowa T, Takahashi K, Fujinaga T. Paravertebral block as a promising analgesic modality for managing post-thoracotomy pain. Ann Thorac Cardiovasc Surg. 2014;20(2):113-6. doi: 10.5761/atcs.oa.12.01999. Epub 2013 Feb 28.
citation: Kimura M, Saito S, Obata H. Dexmedetomidine decreases hyperalgesia in neuropathic pain by increasing acetylcholine in the spinal cord. Neurosci Lett. 2012 Oct 31;529(1):70-4. doi: 10.1016/j.neulet.2012.08.008. Epub 2012 Aug 16.
citation: El-Morsy GZ, El-Deeb A, El-Desouky T, Elsharkawy AA, Elgamal MA. Can thoracic paravertebral block replace thoracic epidural block in pediatric cardiac surgery? A randomized blinded study. Ann Card Anaesth. 2012 Oct-Dec;15(4):259-63. doi: 10.4103/0971-9784.101848.