NCT04482192

Brief Summary

to evaluate the safety and efficacy of continuous paravertebral block by intraoperative direct access on postthoracotomy pain compared to systemic analgesia.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2015

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2015

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 22, 2020

Completed
Last Updated

July 23, 2020

Status Verified

July 1, 2020

Enrollment Period

4.6 years

First QC Date

July 16, 2020

Last Update Submit

July 21, 2020

Conditions

Post Thoracotomy Pain

Keywords

Paravertebral blockPostthoracotomy analgesiaSystemic analgesiaLidocaine infusion

Outcome Measures

Primary Outcomes (2)

  • Pain score on visual analogue scale (VAS) at rest

    Paper-based visual analogue scale (VAS) is used for pain assessment. It provides a range of scores from 0-10. A higher score indicates greater pain intensity.

    24 hours after operation

  • Pain score on visual analogue scale (VAS) on coughing

    Paper-based visual analogue scale (VAS) is used for pain assessment. It provides a range of scores from 0-10. A higher score indicates greater pain intensity.

    24 hours after operation

Secondary Outcomes (4)

  • Total morphine consumption

    end of first postoperative day

  • Forced vital capacity (FVC)

    24 hours after operation

  • Forced expiratory volume in 1s (FEV1)

    24 hours after operation

  • Peak expiratory flow rate (PEFR)

    24 hours after operation

Study Arms (2)

Thoracic paravertebral block group

ACTIVE COMPARATOR

Continuous thoracic paravertebral block with 1% lidocaine infusion for 3 postoperative days through a paravertebral catheter inserted intraoperatively by the surgeon.

Combination Product: Thoracic paravertebral block

Systemic analgesia group

ACTIVE COMPARATOR

patients in this group will receive paracetamol and ketorolac by intravenous infusion every 6 hours for 3 postoperative days

Drug: Systemic analgesia

Interventions

Thoracic paravertebral blockCOMBINATION_PRODUCT

After ending pulmonary procedure, a pleural pouch created beside vertebral column, a catheter is inserted to the pouch for continuous infusion of 1% lidocaine for 3 postoperative days. Intravenous morphine sulfate (0.05mg/kg) was given as a rescue medication if the VAS ≥ 4.

Also known as: Study group
Thoracic paravertebral block group
Systemic analgesiaDRUG

Systemic analgesia (SA) group receive 1gm paracetamol and 30 mg ketorolac by intravenous infusion every 6 hours for 3 days. Intravenous morphine sulfate (0.05mg/kg) was given as a rescue medication if the VAS ≥ 4.

Also known as: Control group
Systemic analgesia group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective posterolateral thoracotomy surgery
  • American Society of Anesthesiologists (ASA) physical status of II and III

You may not qualify if:

  • lack of patient consent.
  • patients younger than 18 years,
  • emergency surgery,
  • previous thoracotomy,
  • drug addiction,
  • allergy to paracetamol (acetaminophen) or ketorolac,
  • coagulopathy,
  • hepatic dysfunction,
  • chronic renal failure,
  • history of gastric ulcer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Krakowski JC, Arora H. Con: Thoracic Epidural Block Is Not Superior to Paravertebral Blocks for Open Thoracic Surgery. J Cardiothorac Vasc Anesth. 2015 Dec;29(6):1720-2. doi: 10.1053/j.jvca.2015.06.012. Epub 2015 Jun 10. No abstract available.

    PMID: 26386503RESULT

  • Fortier S, Hanna HA, Bernard A, Girard C. Comparison between systemic analgesia, continuous wound catheter analgesia and continuous thoracic paravertebral block: a randomised, controlled trial of postthoracotomy pain management. Eur J Anaesthesiol. 2012 Nov;29(11):524-30. doi: 10.1097/EJA.0b013e328357e5a1.

    PMID: 22914044RESULT

  • Sabanathan S, Smith PJ, Pradhan GN, Hashimi H, Eng JB, Mearns AJ. Continuous intercostal nerve block for pain relief after thoracotomy. Ann Thorac Surg. 1988 Oct;46(4):425-6. doi: 10.1016/s0003-4975(10)64657-7.

    PMID: 3178353RESULT

  • Berrisford RG, Sabanathan SS. Direct access to the paravertebral space at thoracotomy. Ann Thorac Surg. 1990 May;49(5):854. doi: 10.1016/0003-4975(90)90058-e. No abstract available.

    PMID: 2339953RESULT

  • Wojtys ME, Wasikowski J, Wojcik N, Wojcik J, Wasilewski P, Lisowski P, Grodzki T. Assessment of postoperative pain management and comparison of effectiveness of pain relief treatment involving paravertebral block and thoracic epidural analgesia in patients undergoing posterolateral thoracotomy. J Cardiothorac Surg. 2019 Apr 16;14(1):78. doi: 10.1186/s13019-019-0901-3.

    PMID: 30992044RESULT

  • Elia N, Lysakowski C, Tramer MR. Does multimodal analgesia with acetaminophen, nonsteroidal antiinflammatory drugs, or selective cyclooxygenase-2 inhibitors and patient-controlled analgesia morphine offer advantages over morphine alone? Meta-analyses of randomized trials. Anesthesiology. 2005 Dec;103(6):1296-304. doi: 10.1097/00000542-200512000-00025.

    PMID: 16306743RESULT

  • Batra RK, Krishnan K, Agarwal A. Paravertebral block. J Anaesthesiol Clin Pharmacol. 2011 Jan;27(1):5-11. No abstract available.

    PMID: 21804697RESULT

  • Katayama T, Hirai S, Kobayashi R, Hamaishi M, Okada T, Mitsui N. Safety of the paravertebral block in patients ineligible for epidural block undergoing pulmonary resection. Gen Thorac Cardiovasc Surg. 2012 Dec;60(12):811-4. doi: 10.1007/s11748-012-0149-5. Epub 2012 Sep 16.

    PMID: 22983833RESULT

Related Links

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Ahmed Deebis, MD

    Zagazig University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor cardiothoracic surgery

Study Record Dates

First Submitted

July 16, 2020

First Posted

July 22, 2020

Study Start

June 15, 2015

Primary Completion

January 31, 2020

Study Completion

March 31, 2020

Last Updated

July 23, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

All authors of the study will share individual participant data (IPD)

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
after ending total collection of data till ending of writing the manuscript
Access Criteria
personal communication