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

Not Applicable

Completed

• Conditions: Surgery
• Interventions: Drug: Ropivacaine; Other: saline; Drug: Dexamethasone

• Registration Number: NCT02871193
• Lead Sponsor: The First Affiliated Hospital of Anhui Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-01
• Study First Submitted: 2016-07-17
• Study First Submitted QC: 2016-08-12
• Study First Posted: 2016-08-18
• Primary Completion: 2016-10-08
• Study Completion: 2017-01-20
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-08
• Last Update Posted: 2017-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group D(Dexamethasone)	Ropivacaine	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 C（Control）	saline	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 R(Ropivacaine)	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 D(Dexamethasone)	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.

Primary Outcome Measures

Name	Time	Method
the change of visual analogue scale(VAS) of patients with different treatment-related events in the following 3 days after thoracotomy	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	6hours,12hours,24hours and 72hours after operation	to show the consumption of analgesics after surgery

Secondary Outcome Measures

Name	Time	Method
The first day of leaving bed after surgery	30 days after surgery
The time of recovery	24 hours after surgery	to show the quality of recovery
the incidence of side effects	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.
hemodynamic index	24 hours after anesthesia	To show the changing trend of hemodynamics with different treatment-related events when receiving thoracotomy.
The complication after surgery	30 days after surgery	To compare the incidence rates of complications, such as pneumonia, atelectasis, respiratory failure, heart failure, etc
The time of extubation	24 hours after surgery	to show the quality of recovery

Trial Locations

Locations (1)

The first affiliated hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China