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

NCT02871193 | Completed DMC

• 1 other identifier: Kuai2016-06-08
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery

Keywords

paravertebral block; patient controlled analgesia; ropivacaine; dexamethasone

Outcome Measures

Primary Outcomes (2)

• the change of visual analogue scale(VAS) of patients with different treatment-related events in the following 3 days after thoracotomy

  to show the grading of pain in different groups after surgery

  6 hours,12hours,24hours and 72hours after operation

• the reality pressing number of patient controlled analgesia(PCA) of patients with different treatment-related events in the following 3 days after surgery

  to show the consumption of analgesics after surgery

  6hours,12hours,24hours and 72hours after operation

Secondary Outcomes (6)

• hemodynamic index

  24 hours after anesthesia

• The time of recovery

  24 hours after surgery

• The time of extubation

  24 hours after surgery

• the incidence of side effects

  3days after operation

• The complication after surgery

  30 days after surgery

Study Arms (3)

Group C（Control）

SHAM COMPARATOR

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.

Other: saline

Group R(Ropivacaine)

EXPERIMENTAL

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.

Drug: Ropivacaine

Group D(Dexamethasone)

EXPERIMENTAL

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.

Drug: Ropivacaine; Drug: Dexamethasone

Interventions

Ropivacaine DRUG

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

Also known as: ropivacaine hydrochloride

Group D(Dexamethasone); Group R(Ropivacaine)

Dexamethasone DRUG

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

Also known as: dxm, dex

Group D(Dexamethasone)

saline OTHER

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

Also known as: normal saline

Group C（Control）

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient American Society of Anesthesiologists（ASA） I\~III undergoing elective thoracotomy
• written informed consent from the patient or the relatives of the participating patient

You may not qualify if:

• mental illness
• thoracic paravertebral blocks contraindicated
• local anesthetic allergy
• people who have heart disease
• people who have severe liver or renal disease
• people who have severe endocrine disease
• people who can't communicate effectively because of hearing or visual disorders

Sponsors & Collaborators

• The First Affiliated Hospital of Anhui Medical University: lead

Study Sites (1)

The first affiliated hospital of Anhui Medical University

Hefei, Anhui, 230000, China

Location

Related Publications (5)

• 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.

  PMID: 20599397 RESULT

• 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.

  PMID: 26938764 RESULT

• 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.

  PMID: 24448512 RESULT

• 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.

  PMID: 26612450 RESULT

• 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.

  PMID: 25123271 RESULT

MeSH Terms

Interventions

Ropivacaine; Dexamethasone; Calcium Dobesilate; Sodium Chloride; Saline Solution

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2016
• First Posted: August 18, 2016
• Study Start: June 1, 2016
• Primary Completion: October 8, 2016
• Study Completion: January 20, 2017
• Last Updated: February 9, 2017

Record last verified: 2017-02

Locations

CN (1)