Effects of Dexmedetomidine Used in Continuous Thoracic Paravertebral Blocks
- Conditions
- Post-thoracotomy Pain Syndrome
- Interventions
- Registration Number
- NCT02619513
- Lead Sponsor
- Weifeng Tu
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- ASA Ⅰ～Ⅲ patient undergoing thoracotomy;
- Written informed consent from the patient or the relatives of the participating patient.
- BMI:18～25kg/m2
- Mental illness;
- Epidural anesthesia or thoracic paravertebral blocks contraindicated;
- People who have Slow-type arrhythmias or hypotension;
- People who have lung infection or sleep apnea syndrome;
- People who have chronic renal failure;
- Alcohol or drug abuse;
- Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug;
- Local anesthetics allergy;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TEB group(Group GE) Ropivacaine Group GE received continuous thoracic epidural block(TEB) combined with general anesthesia and postoperative continuous thoracic epidural analgesia, and only added ropivacaine in PVB as an postoperative adjuvant. PVB without DEX group (Group GT) Ropivacaine Group GT received ultrasound-guided(Mindray M7 series) continuous thoracic paravertebral nerve block(PVB) combined with general anesthesia and continuous thoracic paravertebral nerve block patient-controlled analgesia, and only added ropivacaine in PVB as an postoperative adjuvant. PVB without DEX group (Group GT) Mindray M7 series Group GT received ultrasound-guided(Mindray M7 series) continuous thoracic paravertebral nerve block(PVB) combined with general anesthesia and continuous thoracic paravertebral nerve block patient-controlled analgesia, and only added ropivacaine in PVB as an postoperative adjuvant. PVB with DEX group(Group GTD) Mindray M7 series Group GTD received ultrasound-guided(Mindray M7 series) continuous thoracic paravertebral nerve block combined with general anesthesia and continuous thoracic paravertebral nerve block patient-controlled analgesia,but with dexmedetomidine 0.5μg/kg added to ropivacaine in PVB as an adjuvant. PVB with DEX group(Group GTD) Dexmedetomidine Group GTD received ultrasound-guided(Mindray M7 series) continuous thoracic paravertebral nerve block combined with general anesthesia and continuous thoracic paravertebral nerve block patient-controlled analgesia,but with dexmedetomidine 0.5μg/kg added to ropivacaine in PVB as an adjuvant. PVB with DEX group(Group GTD) Ropivacaine Group GTD received ultrasound-guided(Mindray M7 series) continuous thoracic paravertebral nerve block combined with general anesthesia and continuous thoracic paravertebral nerve block patient-controlled analgesia,but with dexmedetomidine 0.5μg/kg added to ropivacaine in PVB as an adjuvant.
- Primary Outcome Measures
Name Time Method Baseline mechanical withdrawal threshold(unit: g) of patients without treatment-related events. 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.
The change of Interleukin-6(IL-6) of patients with different treatment-related events during the perioperative period. 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.
The change of tumor necrosis factor-α(TNF-α) of patients with different treatment-related events during the perioperative period. 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.
The change of mechanical withdrawal threshold(unit: g) of patients with different treatment-related events in the following one week after thoracotomy. 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.
The change of Interleukin-10(IL-10) of patients with different treatment-related events during the perioperative period. 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.
- Secondary Outcome Measures
Name Time Method The intraoperative consumption of opioids. 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).
A questionnaire related to postoperation chronic for the patients who have receiving thoracotomy. 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.
The postoperative consumption of opioids. 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).
The change of mean arterial pressure (MAP) of the patients when receiving the thoracotomy. 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.
The change of heart rate(HR) of the patients when receiving the thoracotomy. 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.
The incidence rates of side effects. 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.
The change of visual analogue scale(VAS) of patients with different treatment-related events in the following one week after thoracotomy. 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.
Trial Locations
- Locations (1)
Department of Anesthesiology，Guangzhou Military Region General Hospital
🇨🇳Guangzhou, Guangdong, China