NCT02886429

Brief Summary

Postoperative pain is the most undesired consequence of surgery, and if not managed adequately, can lead to delayed recovery and increased hospital stay. Surveys continue to reveal that postoperative pain is insufficiently managed throughout the first world, let alone in the Third World. An American survey over 20 years showed that only one in four patients had adequate relief of postoperative pain. This has led recovery room protocols to include pain as a fifth vital sign that needs to be addressed before patients are discharged to the ward

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2016

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

August 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

December 4, 2018

Status Verified

December 1, 2018

Enrollment Period

2 years

First QC Date

August 27, 2016

Last Update Submit

December 2, 2018

Conditions

Pain, Postoperative

Keywords

dexmedetomidinebupivacaineUltrasound guided paravertebral blockpainpost-thoracotomy

Outcome Measures

Primary Outcomes (1)

  • post-thoracotomy pain

    5\. Pain scores at rest and on coughing will be recorded using visual analogue scale (VAS) pain intensities at rest and during coughing/movement assessed by VAS score. The quality of effective analgesia will be expressed as VAS values derived from the VAS pain score, at rest and during coughing during each assessment period (2 h, at 4, 8 and 24 h).

    within first 24 hours after Video Assisted Thoracoscopy Surgery

Secondary Outcomes (4)

  • pulmonary function tests

    within first 24 hours after Video Assisted Thoracoscopy Surgery

  • rescue analgesia

    within first 24 hours after Video Assisted Thoracoscopy Surgery

  • sedation score

    within first 24 hours after Video Assisted Thoracoscopy Surgery

  • nausea, vomiting

    within first 24 hours after Video Assisted Thoracoscopy Surgery

Study Arms (2)

Group A

ACTIVE COMPARATOR

Ultrasound guided paravertebral block with bupivacaine group Thirty patients will be given isobaric bupivacaine 0.5% (0.3ml/kg) via paravertebral route.

Drug: Bupivacaine

Group B

ACTIVE COMPARATOR

Ultrasound guided paravertebral block with bupivacaine and dexmedetomidine group Thirty patients will be given isobaric bupivacaine 0.5% (0.3ml/kg) and dexmedetomidine (1 mcg/kg) via paravertebral route (Bupivacaine plus Dexmedetomidine)

Drug: BupivacaineDrug: Dexmedetomidine

Interventions

BupivacaineDRUG

Ultrasound guided paravertebral block with bupivacaine

Also known as: Marcaine
Group AGroup B
DexmedetomidineDRUG

Ultrasound guided paravertebral block with dexmedetomidine

Also known as: Precedex
Group B

Eligibility Criteria

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

You may qualify if:

  • ASA I, II and III.
  • In the age ranged between 18 up to 60 years.
  • Elective video-assisted thoracoscopy

You may not qualify if:

  • ASA IV and V
  • Liver impairment
  • Renal impairment
  • allergy to the drugs used
  • Known contraindication for regional techniques such as:
  • Infection near the site of the needle insertion
  • Coagulopathy
  • Anti-coagulation therapy,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Asyut, Egypt

Location

MeSH Terms

Conditions

Pain, PostoperativePain

Interventions

BupivacaineDexmedetomidine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Sayed K Abd-Elshafy, MD

    Associate professor of anesthesia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate profossor of anesthesia

Study Record Dates

First Submitted

August 27, 2016

First Posted

September 1, 2016

Study Start

August 1, 2016

Primary Completion

August 1, 2018

Study Completion

October 1, 2018

Last Updated

December 4, 2018

Record last verified: 2018-12

Locations

EG(1)