NCT02871193

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

Completed NA Last updated 9 February 2017

What this trial tests

NA trial testing Ropivacaine in Surgery in 68 participants. Completed in 20 January 2017.

Timeline

1 June 2016

Primary endpoint
8 October 2016

20 January 2017

Quick facts

Lead sponsor	The First Affiliated Hospital of Anhui Medical University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	68
Start date	1 June 2016
Primary completion	8 October 2016
Estimated completion	20 January 2017
Sites	1 location across China

Drugs / interventions tested

• Ropivacaine (ROPIVACAINE) — full drug profile →
• Dexamethasone (dexamethasone) — full drug profile →
• saline

Conditions studied

• Surgery — all drugs for Surgery →

Sponsor

The First Affiliated Hospital of Anhui Medical University

Who can join

Adults 19 to 80, any sex, with Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.