Department of Anesthesiology,Guangzhou Military Region General Hospital
Guangzhou, Guangdong, 510010, China
NCT Number: NCT02619513
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).
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Notify Me19 year–76 year
All sexes
Interventional
Phase 4
Guangzhou, Guangdong, 510010, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Group GTD received thoracic continuous paravertebral nerve block with dexmedetomidine (0.5μg/kg) added to ropivacaine before anesthesia induction, and used continuous thoracic paravertebral nerve block patient-controlled analgesia(with dexmedetomidine 100μg).
Group GE\\GT\\GTD respectively received continuous nerve blocks and postoperative analgesia combined with ropivacaine.
Ultrasound real-time guidance have been used in continuous thoracic paravertebral blocks in group GT and group GTD.
Time frame: the day before the operation
Baseline quantization degree of algesia without treatment-related events before receiving thoracotomy measured by Electric Von Frey 2391, and the testing position is located in the intercostal skin at the level of operation incisions, which about 2cm away from the incision.
Time frame: 12, 24, 48, 72h and 1w after the operation
To show the changing trend of quantization degree of hyperalgesia and allodynia with different treatment-related events after receiving thoracotomy measured by Electric Von Frey 2391, and the testing position is located in the intercostal skin at the level of operation incisions, which about 2cm away from the incision.
Time frame: pre-operation and 6, 24, 72h after the operation
The changing trend of plasma IL- 6 in venous blood of patients with different treatment-related events during the perioperative period. And the blood time is in the morning before patients feed at each expected testing time point.
Time frame: pre-operation and 6, 24, 72h after the operation
The changing trend of plasma IL-10 in venous blood of patients with different treatment-related events during the perioperative period. And the blood time is in the morning before patients feed at each expected testing time point.
Time frame: pre-operation and 6, 24, 72h after the operation
The changing trend of TNF-α in venous blood of patients with different treatment-related events during the perioperative period. And the blood time is in the morning before patients feed at each expected testing time point.
Time frame: 12, 24, 48, 72h and 1w after the operation
To show the changing trend of visual analogue scale(VAS) in order to subjectively speculate the degree of hyperalgesia and allodynia with different treatment-related events after receiving thoracotomy, and the testing position is located in the intercostal skin at the level of operation incisions, which about 2cm away from the incision.
Time frame: From the beginning to the end of the anesthesia procedure.
The consumption of opioid(remifentanil and sufentanil) during the operation are recorded(the consumption of sufentanil was converted to the consumption of remifentanil producing the equivalent effect by 1:10,unit:mg).
Time frame: in the first 3 days after operation
If insufficient analgesia happens(resting VAS scores>4), than use dezocine intravenously as additional analgesia(a single dose 5-20mg, no more than 120mg per day). The consumption of opioid(dezocine) in the following 3 days after the operation are recorded(unit:mg).
Time frame: 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)
To show the changing trend of hemodynamics with different treatment-related events when receiving thoracotomy.
Time frame: 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)
To show the changing trend of hemodynamics with different treatment-related events when receiving thoracotomy.
Time frame: in the first 3 days after operation
To compare the incidence rates of side effects, such as nausea, vomiting, dizziness, hypotension and bradyarrhythmia in the first 3 days after operation.
Time frame: at 6 months after operation
A questionnaire is adopted to investigate whether there are chronic pain symptoms happen at 6 months after the operation which aim to PTPS.
Weifeng Tu
Other
Effects of Dexmedetomidine as an Adjunctive Analgesic Used in Continuous Thoracic Paravertebral Blocks for Post-thoracotomy Pain Syndrome
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