Clinical trial NCT02871193: Ultrasound-guided Thoracic Paravertebral Block Using Ropivacaine With/Without Dexamethasone in Elective Thoracotomy
Official title: Study of Ultrasound-guided Thoracic Paravertebral Block Using Ropivacaine With/Without Dexamethasone in Elective Thoracotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Keywords: paravertebral block
patient controlled analgesia
ropivacaine
dexamethasone
Lead sponsor: The First Affiliated Hospital of Anhui Medical University
Sponsor class: OTHER
First posted: 2016-08-18
Enrollment: 68
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: the change of visual analogue scale(VAS) of patients with different treatment-related events in the following 3 days after thoracotomy
timeFrame: 6 hours,12hours,24hours and 72hours after operation
measure: the reality pressing number of patient controlled analgesia(PCA) of patients with different treatment-related events in the following 3 days after surgery
timeFrame: 6hours,12hours,24hours and 72hours after operation
Secondary outcomes:
measure: hemodynamic index
timeFrame: 24 hours after anesthesia
measure: The time of recovery
timeFrame: 24 hours after surgery
measure: The time of extubation
timeFrame: 24 hours after surgery
measure: the incidence of side effects
timeFrame: 3days after operation
measure: The complication after surgery
timeFrame: 30 days after surgery
measure: The first day of leaving bed after surgery
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Hefei
country: China
facility: The first affiliated hospital of Anhui Medical University
state: Anhui
Study officials:
References:
citation: Carmona P, Llagunes J, Canovas S, de Andres J, Marques I. The role of continuous thoracic paravertebral block for fast-track anesthesia after cardiac surgery via thoracotomy. J Cardiothorac Vasc Anesth. 2011 Feb;25(1):205-6. doi: 10.1053/j.jvca.2010.04.005. No abstract available.
citation: Tomar GS, Ganguly S, Cherian G. Effect of Perineural Dexamethasone With Bupivacaine in Single Space Paravertebral Block for Postoperative Analgesia in Elective Nephrectomy Cases: A Double-Blind Placebo-Controlled Trial. Am J Ther. 2017 Nov/Dec;24(6):e713-e717. doi: 10.1097/MJT.0000000000000405.
citation: Ilfeld BM, Madison SJ, Suresh PJ, Sandhu NS, Kormylo NJ, Malhotra N, Loland VJ, Wallace MS, Proudfoot JA, Morgan AC, Wen CH, Wallace AM. Treatment of postmastectomy pain with ambulatory continuous paravertebral nerve blocks: a randomized, triple-masked, placebo-controlled study. Reg Anesth Pain Med. 2014 Mar-Apr;39(2):89-96. doi: 10.1097/AAP.0000000000000035.
citation: Ke JD, Hou HJ, Wang M, Zhang YJ. The comparison of anesthesia effect of lung surgery through video-assisted thoracic surgery: A meta-analysis. J Cancer Res Ther. 2015 Nov;11 Suppl:C265-70. doi: 10.4103/0973-1482.170534.
citation: Albrecht E, Kern C, Kirkham KR. A systematic review and meta-analysis of perineural dexamethasone for peripheral nerve blocks. Anaesthesia. 2015 Jan;70(1):71-83. doi: 10.1111/anae.12823. Epub 2014 Aug 14.