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Clinical Trials/NCT02871193
NCT02871193
Completed
Not Applicable

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

The First Affiliated Hospital of Anhui Medical University1 site in 1 country68 target enrollmentJune 1, 2016

Overview

Phase
Not Applicable
Intervention
saline
Conditions
Surgery
Sponsor
The First Affiliated Hospital of Anhui Medical University
Enrollment
68
Locations
1
Primary Endpoint
the change of visual analogue scale(VAS) of patients with different treatment-related events in the following 3 days after thoracotomy
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2016
End Date
January 20, 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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

Arms & Interventions

Group C(Control)

Group C received ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.9% saline 20ml combined with general anesthesia and intravenous patient controlled analgesia pump.

Intervention: saline

Group R(Ropivacaine)

Group R received ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.5% ropivacaine 20 ml combined with general anesthesia and intravenous patient controlled analgesia pump.

Intervention: Ropivacaine

Group D(Dexamethasone)

Group D received ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.5% ropivacaine 20ml and dexamethasone 5 mg combined with general anesthesia and intravenous patient controlled analgesia pump.

Intervention: Ropivacaine

Group D(Dexamethasone)

Group D received ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.5% ropivacaine 20ml and dexamethasone 5 mg combined with general anesthesia and intravenous patient controlled analgesia pump.

Intervention: Dexamethasone

Outcomes

Primary Outcomes

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

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

  • The first day of leaving bed after surgery(30 days after surgery)
  • The time of recovery(24 hours after surgery)
  • The time of extubation(24 hours after surgery)
  • the incidence of side effects(3days after operation)
  • hemodynamic index(24 hours after anesthesia)
  • The complication after surgery(30 days after surgery)

Study Sites (1)

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