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Completed

NCT Number: NCT02871193

Ultrasound-guided Thoracic Paravertebral Block Using Ropivacaine With/Without Dexamethasone in Elective Thoracotomy

The procedures of thoracotomy are among the most painful operations. In addition to post-thoracotomy pain, the outcomes of surgery are affected adversely by postoperative discomfort. Therefore, post-thoracotomy pain control can improve the satisfaction of patient and prevent postoperative complications such as pneumonia, atelectasis, or respiratory failure. Thoracic epidural analgesia (TEA) used to be widely considered as a standard technique for providing analgesia after a thoracotomy. However, TEA carries side-effects such as incomplete or failed block, epidural hematoma, abscess, hypotension, respiratory depression, or bradycardia, etc. Recently, thoracic paravertebral block (TPVB) is an alternative technique for TEA that may offer a comparable analgesic effect and a better side -effect profile for post-thoracotomy analgesia. When local anesthetic agents are used as single injection, they can provide analgesia for limited period. Various adjuvants have been tried in the past in order to enhance the duration and quality of postoperative analgesia. Previous studies with perineural dexamethasone demonstrated that it enhanced the duration of local anesthetic block. The mechanism of its action is blocking the nociceptive impulse transmission along the myelinated C fibers. Patient-controlled analgesia (PCA) devices have been shown to provide superior analgesia and greater patient satisfaction compared with intermittent administration. System of wire-less PCA provides remote monitoring, information management and PCA devices with high precision. The purpose of this research is to determine whether dexamethasone might prolong the duration of analgesia and improve the short-time outcomes when administered for TPVB along with local anesthetic agents in elective thoracotomy.

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Key information

Conditions

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The first affiliated hospital of Anhui Medical University

Hefei, Anhui, 230000, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patient American Society of Anesthesiologists(ASA) I~III undergoing elective thoracotomy
  • written informed consent from the patient or the relatives of the participating patient

Exclusion criteria

  • mental illness
  • thoracic paravertebral blocks contraindicated
  • local anesthetic allergy
  • people who have heart disease
  • people who have severe liver or renal disease
  • people who have severe endocrine disease
  • people who can't communicate effectively because of hearing or visual disorders

Treatment and study plan

Ropivacaine

Drug

ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.5% ropivacaine 20ml

Other names: ropivacaine hydrochloride

Dexamethasone

Drug

ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.5% ropivacaine 20ml and dexamethasone 5 mg

Other names: dxm, dex

Saline

Other

ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.9% saline 20ml

Other names: normal saline

Primary outcomes

  1. the change of visual analogue scale(VAS) of patients with different treatment-related events in the following 3 days after thoracotomy

    Time frame: 6 hours,12hours,24hours and 72hours after operation

    to show the grading of pain in different groups after surgery

  2. the reality pressing number of patient controlled analgesia(PCA) of patients with different treatment-related events in the following 3 days after surgery

    Time frame: 6hours,12hours,24hours and 72hours after operation

    to show the consumption of analgesics after surgery

Secondary outcomes

  1. hemodynamic index

    Time frame: 24 hours after anesthesia

    To show the changing trend of hemodynamics with different treatment-related events when receiving thoracotomy.

  2. The time of recovery

    Time frame: 24 hours after surgery

    to show the quality of recovery

  3. The time of extubation

    Time frame: 24 hours after surgery

    to show the quality of recovery

  4. the incidence of side effects

    Time frame: 3days 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.

  5. The complication after surgery

    Time frame: 30 days after surgery

    To compare the incidence rates of complications, such as pneumonia, atelectasis, respiratory failure, heart failure, etc

  6. The first day of leaving bed after surgery

    Time frame: 30 days after surgery

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Anhui Medical University

Other

Registry information

Official study title

Study of Ultrasound-guided Thoracic Paravertebral Block Using Ropivacaine With/Without Dexamethasone in Elective Thoracotomy

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Aug 18, 2016
Registry last updated
Feb 9, 2017

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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