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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-01

Study Completion Date

2017-01-20

Brief Summary

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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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Detailed Description

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Conditions

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Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type SHAM_COMPARATOR

saline

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Ropivacaine

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Ropivacaine

Intervention Type DRUG

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

Dexamethasone

Intervention Type DRUG

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

Interventions

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Ropivacaine

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

Intervention Type DRUG

Dexamethasone

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

Intervention Type DRUG

saline

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

Intervention Type OTHER

Other Intervention Names

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ropivacaine hydrochloride dxm dex normal saline

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No