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Post- Thoracotomy Paravertebral Block

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Bupivacaine
Dexmedetomidine
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring dexmedetomidine, bupivacaine, Ultrasound guided paravertebral block, pain, post-thoracotomy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. ASA IV and V
  2. Liver impairment
  3. Renal impairment
  4. allergy to the drugs used
  5. Known contraindication for regional techniques such as:

    • Infection near the site of the needle insertion
    • Coagulopathy
    • Anti-coagulation therapy,

Sites / Locations

  • Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A

Group B

Arm Description

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

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)

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

pulmonary function tests
done preoperatively and at postoperative period
rescue analgesia
Consumption of IV rescue analgesia attained with ketorolac tromethamine (30 mg per dose).
sedation score
Richmond Agitation Sedation Score
nausea, vomiting
nausea, vomiting

Full Information

First Posted
August 27, 2016
Last Updated
December 2, 2018
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT02886429
Brief Title
Post- Thoracotomy Paravertebral Block
Official Title
Safety and Efficacy of Ultrasound Guided Paravertebral Dexmedetomidine for Postoperative Pain Relief in Video Assisted Thoracoscopy Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
This prospective, randomized, double-blinded, parallel assignment clinical trial will be done after receiving approval from the local ethics committee of the Faculty of Medicine, Assiut University. A written informed consent will be taken after discussing a detailed description of the study with the patients. Patients will be allocated randomly into two equal groups by computer programs and will be contained in sealed opaque envelopes. Patients will be premedicated with midazolam (0.1mg/kg), 30 min before the operation. Patients will be monitored with ECG, non-invasive blood pressure, heart rate, temperature, oxygen saturation, exhaled CO2 (end tidal capnography), and train of four. In both groups, general anesthesia will be induced with propofol (2mg/kg) and fentanyl (1 mcg/kg). Tracheal intubation will be facilitated with cisatracurium 0.1 mg/kg. Anesthesia will be maintained with isoflurane (1-2 %) and cisatracurium (0.05 mg/kg per dose). Fentanyl (0.5mcg/kg) will be repeated if heart rate (HR) and/or mean arterial pressure (MAP) rise 20 % above baseline values. After the end of anesthesia induction and before surgical procedure Technique of ultrasound guided paravertebral block will be done in both groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
dexmedetomidine, bupivacaine, Ultrasound guided paravertebral block, pain, post-thoracotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Ultrasound guided paravertebral block with bupivacaine group Thirty patients will be given isobaric bupivacaine 0.5% (0.3ml/kg) via paravertebral route.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Marcaine
Intervention Description
Ultrasound guided paravertebral block with bupivacaine
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
Ultrasound guided paravertebral block with dexmedetomidine
Primary Outcome Measure Information:
Title
post-thoracotomy pain
Description
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).
Time Frame
within first 24 hours after Video Assisted Thoracoscopy Surgery
Secondary Outcome Measure Information:
Title
pulmonary function tests
Description
done preoperatively and at postoperative period
Time Frame
within first 24 hours after Video Assisted Thoracoscopy Surgery
Title
rescue analgesia
Description
Consumption of IV rescue analgesia attained with ketorolac tromethamine (30 mg per dose).
Time Frame
within first 24 hours after Video Assisted Thoracoscopy Surgery
Title
sedation score
Description
Richmond Agitation Sedation Score
Time Frame
within first 24 hours after Video Assisted Thoracoscopy Surgery
Title
nausea, vomiting
Description
nausea, vomiting
Time Frame
within first 24 hours after Video Assisted Thoracoscopy Surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA I, II and III. In the age ranged between 18 up to 60 years. Elective video-assisted thoracoscopy Exclusion Criteria: 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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sayed K Abd-Elshafy, MD
Organizational Affiliation
Associate professor of anesthesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine
City
Assiut
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Post- Thoracotomy Paravertebral Block

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