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OpenTrials
Completed

NCT Number: NCT02619513

Effects of Dexmedetomidine Used in Continuous Thoracic Paravertebral Blocks

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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Key information

Age range

19 year–76 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anesthesiology,Guangzhou Military Region General Hospital

Guangzhou, Guangdong, 510010, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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;

Treatment and study plan

Dexmedetomidine

Drug

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).

Ropivacaine

Drug

Group GE\\GT\\GTD respectively received continuous nerve blocks and postoperative analgesia combined with ropivacaine.

Mindray M7 series

Device

Ultrasound real-time guidance have been used in continuous thoracic paravertebral blocks in group GT and group GTD.

Primary outcomes

  1. Baseline mechanical withdrawal threshold(unit: g) of patients without treatment-related events.

    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.

  2. The change of mechanical withdrawal threshold(unit: g) of patients with different treatment-related events in the following one week after thoracotomy.

    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.

  3. The change of Interleukin-6(IL-6) of patients with different treatment-related events during the perioperative period.

    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.

  4. The change of Interleukin-10(IL-10) of patients with different treatment-related events during the perioperative period.

    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.

  5. The change of tumor necrosis factor-α(TNF-α) of patients with different treatment-related events during the perioperative period.

    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.

Secondary outcomes

  1. The change of visual analogue scale(VAS) of patients with different treatment-related events in the following one week after thoracotomy.

    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.

  2. The intraoperative consumption of opioids.

    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).

  3. The postoperative consumption of opioids.

    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).

  4. The change of mean arterial pressure (MAP) of the patients when receiving the 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.

  5. The change of heart rate(HR) of the patients when receiving the 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.

  6. The incidence rates of side effects.

    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.

  7. A questionnaire related to postoperation chronic for the patients who have receiving thoracotomy.

    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.

Sponsors and collaborators

Lead sponsor

Weifeng Tu

Other

Registry information

Official study title

Effects of Dexmedetomidine as an Adjunctive Analgesic Used in Continuous Thoracic Paravertebral Blocks for Post-thoracotomy Pain Syndrome

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 2, 2015
Registry last updated
Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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