Effects of Dexmedetomidine Used in Continuous Thoracic Paravertebral Blocks

NCT ID: NCT02619513

Last Updated: 2015-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-09-30

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.

Conditions

Post-thoracotomy Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

General anesthesia group(Group GA)

Group GA received general anesthesia only and intravenous analgesia pump.

Group Type: NO_INTERVENTION

No interventions assigned to this group

TEB group(Group GE)

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.

Group Type: EXPERIMENTAL

Ropivacaine

Intervention Type: DRUG

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

PVB without DEX group (Group GT)

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.

Group Type: EXPERIMENTAL

Ropivacaine

Intervention Type: DRUG

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

Mindray M7 series

Intervention Type: 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)

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.

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: 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

Intervention Type: DRUG

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

Mindray M7 series

Intervention Type: DEVICE

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

Interventions

Dexmedetomidine

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）.

Intervention Type: DRUG

Ropivacaine

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

Intervention Type: DRUG

Mindray M7 series

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

Intervention Type: DEVICE

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;

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 76 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weifeng Tu

OTHER

Sponsor Role: lead

Responsible Party

Weifeng Tu

Chief Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jie Peng, PhD

Role: PRINCIPAL_INVESTIGATOR

Guangzhou General Hospital of Guangzhou Military Command

Locations

Department of Anesthesiology，Guangzhou Military Region General Hospital

Guangzhou, Guangdong, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 24797238 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23445804 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22917606 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23041682 (View on PubMed)

Other Identifiers

Dexmedetomidine TPVB

Identifier Type: -

Identifier Source: org_study_id