Effects of Dexmedetomidine Used in Continuous Thoracic Paravertebral Blocks

NCT02619513 | Completed Phase 4

• 1 other identifier: Dexmedetomidine TPVB
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Post-thoracotomy Pain Syndrome

Keywords

Paravertebral Blocks; Dexmedetomidine; Analgesia; Inflammatory response; Thoracotomy

Outcome Measures

Primary Outcomes (5)

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

  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 day before the operation

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

  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.

  12, 24, 48, 72h and 1w after the operation

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

  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.

  pre-operation and 6, 24, 72h after the operation

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

  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.

  pre-operation and 6, 24, 72h after the operation

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

  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.

  pre-operation and 6, 24, 72h after the operation

Secondary Outcomes (7)

• 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

• The intraoperative consumption of opioids.

  From the beginning to the end of the anesthesia procedure.

• The postoperative consumption of opioids.

  in the first 3 days after operation

• 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)

• 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)

Study Arms (4)

General anesthesia group(Group GA)

NO INTERVENTION

Group GA received general anesthesia only and intravenous analgesia pump.

TEB group(Group GE)

EXPERIMENTAL

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.

Drug: Ropivacaine

PVB without DEX group (Group GT)

EXPERIMENTAL

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.

Drug: Ropivacaine; Device: Mindray M7 series

PVB with DEX group(Group GTD)

EXPERIMENTAL

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.

Drug: Dexmedetomidine; Drug: Ropivacaine; Device: Mindray M7 series

Interventions

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）.

PVB with DEX group(Group GTD)

Ropivacaine DRUG

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

PVB with DEX group(Group GTD); PVB without DEX group (Group GT); TEB group(Group GE)

Mindray M7 series DEVICE

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

PVB with DEX group(Group GTD); PVB without DEX group (Group GT)

Eligibility Criteria

• Age: 19 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Weifeng Tu: lead

Study Sites (1)

Department of Anesthesiology，Guangzhou Military Region General Hospital

Guangzhou, Guangdong, 510010, China

Location

Related Publications (4)

• 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.

  PMID: 24797238 BACKGROUND

• 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.

  PMID: 23445804 BACKGROUND

• 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.

  PMID: 22917606 BACKGROUND

• 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.

  PMID: 23041682 BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Dexmedetomidine; Ropivacaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Jie Peng, PhD

  Guangzhou General Hospital of Guangzhou Military Command

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: September 22, 2015
• First Posted: December 2, 2015
• Study Start: December 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: December 2, 2015

Record last verified: 2015-11

Locations

CN (1)