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

T

The First Affiliated Hospital of Anhui Medical University

Status

Completed

Conditions

Surgery

Treatments

Drug: Ropivacaine
Other: saline
Drug: Dexamethasone

Study type

Interventional

Funder types

Other

Identifiers

NCT02871193
Kuai2016-06-08

Details and patient eligibility

About

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.

Enrollment

68 patients

Sex

All

Ages

19 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  1. mental illness
  2. thoracic paravertebral blocks contraindicated
  3. local anesthetic allergy
  4. people who have heart disease
  5. people who have severe liver or renal disease
  6. people who have severe endocrine disease
  7. people who can't communicate effectively because of hearing or visual disorders

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

68 participants in 3 patient groups

Group C(Control)
Sham Comparator group
Description:
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.
Treatment:
Other: saline
Group R(Ropivacaine)
Experimental group
Description:
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.
Treatment:
Drug: Ropivacaine
Group D(Dexamethasone)
Experimental group
Description:
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.
Treatment:
Drug: Dexamethasone
Drug: Ropivacaine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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