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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02871193
Enrollment
68
Registered
2016-08-18
Start date
2016-06-01
Completion date
2017-01-20
Last updated
2017-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery

Keywords

paravertebral block, patient controlled analgesia, ropivacaine, dexamethasone

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.

Interventions

DRUGRopivacaine

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

DRUGDexamethasone

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

OTHERsaline

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

Sponsors

The First Affiliated Hospital of Anhui Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the change of visual analogue scale(VAS) of patients with different treatment-related events in the following 3 days after thoracotomy6 hours,12hours,24hours and 72hours after operationto 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 surgery6hours,12hours,24hours and 72hours after operationto show the consumption of analgesics after surgery

Secondary

MeasureTime frameDescription
The time of recovery24 hours after surgeryto show the quality of recovery
The time of extubation24 hours after surgeryto show the quality of recovery
the incidence of side effects3days after operationTo compare the incidence rates of side effects, such as nausea, vomiting, dizziness, hypotension and bradyarrhythmia in the first 3 days after operation.
The first day of leaving bed after surgery30 days after surgery
The complication after surgery30 days after surgeryTo compare the incidence rates of complications, such as pneumonia, atelectasis, respiratory failure, heart failure, etc
hemodynamic index24 hours after anesthesiaTo show the changing trend of hemodynamics with different treatment-related events when receiving thoracotomy.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026