NCT02397603

Brief Summary

This study evaluates the effect of adding dexmedetomidine as an adjuvant to bupivacaine in patients undergoing thoracotomy when administered peri-neurally in thoracic paravertebral space.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

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

February 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 15, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 25, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 2, 2016

Status Verified

January 1, 2016

Enrollment Period

9 months

First QC Date

March 15, 2015

Last Update Submit

January 30, 2016

Conditions

Acute Post-thoracotomy Pain

Outcome Measures

Primary Outcomes (1)

  • Duration of first loading preoperative dose of paravertebral injectate

    Time interval between initiation of the paravertebral block and the time to first rescue analgesia

    One day

Secondary Outcomes (10)

  • Duration of surgery and anesthesia

    Intraoperative period, up to 3-4 hours

  • End tidal isoflurane

    Duration of anesthesia, up to 3-4 hours

  • Total intraoperative fentanyl requirements

    Intraoperative period, up to 3-4 hours

  • Total intraoperative ephedrine and atropine requirements

    Intraoperative period, up to 3-4 hours

  • Total intraoperative crystalloid requirements

    Intraoperative period, up to 3-4 hours

  • +5 more secondary outcomes

Study Arms (2)

bupivacaine saline group

ACTIVE COMPARATOR

This group of patients will receive 20 ml bupivacaine plus 0.5 ml normal saline perineurally in the paravertebral catheter

Drug: Bupivacaine saline

Dexmedetomidine- bupivacaine group

ACTIVE COMPARATOR

This group of patients will receive 20 ml bupivacaine plus 0.5 ml (50 microgram) dexmedetomidine administered perineurally in the paravertebral catheter.

Drug: dexmedetomidine bupivacaine

Interventions

dexmedetomidine bupivacaineDRUG

perineural dexmedetomidine as an adjuvant to bupivacaine induced thoracic paravertebral block

Dexmedetomidine- bupivacaine group
Bupivacaine salineDRUG

perineural bupivacaine saline mixture in the thoracic paravertebral catheter

bupivacaine saline group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • American society of anesthesiologists physical status class \|\|or \|\|\|.
  • Patients scheduled for elective thoracotomy.

You may not qualify if:

  • Pneumonectomy, decortication, pleural biopsy.
  • Additional chest wall resection.
  • Emergency surgery.
  • Central and peripheral neuropathies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy Hospital Cairo University

Giza, Egypt

Location

Related Publications (1)

  • Marhofer D, Kettner SC, Marhofer P, Pils S, Weber M, Zeitlinger M. Dexmedetomidine as an adjuvant to ropivacaine prolongs peripheral nerve block: a volunteer study. Br J Anaesth. 2013 Mar;110(3):438-42. doi: 10.1093/bja/aes400. Epub 2012 Nov 15.

    PMID: 23161360RESULT

Study Officials

  • Mohamed Abdulatif, MD.

    Professor of anesthesia, surgical intensive care and pain management cairo university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology & Surgical Intensive Care, Faculity of Medicine

Study Record Dates

First Submitted

March 15, 2015

First Posted

March 25, 2015

Study Start

February 1, 2015

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

February 2, 2016

Record last verified: 2016-01

Locations

EG(1)