Plain English Summary
Background and study aims
Thoracic surgery includes operations on all parts of the chest including the chest wall, the contents of the chest and the lungs, except for heart surgery. A thoracotomy is a surgical incision (cut) into the chest wall to open the chest cavity. Post-thoracotomy pain is felt in the back and chest region after a thoracotomy. The aim of this study is to find out whether dexmedetomidine plus local anesthetic Levobupivacaine could extend pain relief time compared with Levobupivacaine alone at the end of thoracic surgery.
Who can participate?
Patients aged 20-60 undergoing elective thoracic surgery
What does the study involve?
Participants are randomly allocated to one of two groups. One group receive levobupivacaine and the other group receive levobupivacaine plus dexmedetomidine. Participants’ pain, opioid (pain relief) consumption and adverse effects are monitored.
What are the possible benefits and risks of participating?
The results of this study will help to confirm the best method of pain relief and the patient may benefit from pain relief. No risks are expected.
Where is the study run from?
National Cancer Institute, Cairo University (Egypt)
When is the study starting and how long is it expected to run for?
March to September 2017
Who is funding the study?
National Cancer Institute, Cairo University (Egypt)
Who is the main contact?
Dr Ahmed Bakir
ahmed_bakir77@yahoo.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Ahmed Bakeer
ORCID ID
Contact details
Cairo University
Cairo
-
Egypt
+20 (0)111 566 1922
ahmed_bakir77@yahoo.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
201617011.2p
Study information
Scientific title
Ultrasound guided continous serratus anterior plane block :dexmedetomidine as an adjunctive analgesic with levobupivacine for post thoracotomy pain: a prospective randomized controlled study
Acronym
Study hypothesis
Dexmedetomidine plus local anesthetic levobupivacaine could extend pain relief time compared only with levobupivacaine when ultrasound guided serratus anterior block is performed at the end of thoracic surgery.
Ethics approval
Ethics committee of National Cancer Institute, Cairo University, 04/04/2017, ref: 201617011.2b
Study design
Interventional prospective randomized controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
No participant information sheet available
Condition
Post-thoracotomy pain
Intervention
Patients will be randomized by double-blind simple randomization to two groups.
1. 25 patients will receive a bolus of 30 ml of 0.25% levobupivacaine followed by an infusion of 5 ml/hour of 0.125% levobupivacaine.
2. 25 patients will receive a bolus of 30 ml of 0.25% levobupivacaine plus 1 ug/kg dexmedetomidine followed by an infusion of 0.125% levobupivacaine plus 0.2 ug/kg/hour dexmedetomidine at a rate of 5 ml/hour.
All patients receive the study medications through ultrasound-guided serratus anterior catheter.
Patients will be monitored for:
1. Arterial blood pressure, heart rate and oxygen saturation every 10 min for the initial one hour of the blockade; subsequently every half an hour for the next 2 hours and then 2 hourly for the next 12 hours. As soon as the patient is alert enough VAS pain score will be recorded every 2 hours
2. Total morphine consumption during first 24 hours postoperatively
3. Sign of morphine side effects such as nausea, vomiting, dizziness, an unusual pleasant feeling, sweating, headache, anxiety and constipation
Intervention type
Drug
Phase
Not Applicable
Drug names
Levobupivacaine, dexmedetomidine
Primary outcome measure
Postoperative pain at rest and coughing, measured by VAS pain score (10 mm vertical scale from 0-10 where zero means no pain and 10 is the worst pain) every 2h in the first 24h postoperative
Secondary outcome measures
1. Postoperative opioid consumption, recorded by staff during first 24 hours postoperative
2. Adverse effects including nausea, vomiting, hypotension and cardiac arrhythmias, recorded by staff in the first 24h postoperative
Overall trial start date
10/03/2017
Overall trial end date
10/09/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age from 20-60
2. ASA 2 or 3
3. Undergoing elective thoracic surgery
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
25 patients in each group
Total final enrolment
50
Participant exclusion criteria
1. Refusal of the patient
2. Coagulopathy
3. Severe cardiac or renal impairment or hepatic disease
4. Known allergy to the study drugs
Recruitment start date
10/04/2017
Recruitment end date
10/08/2017
Locations
Countries of recruitment
Egypt
Trial participating centre
National Cancer Institute, Cairo University
-
Egypt
Sponsor information
Organisation
National Cancer Institute, Cairo University
Sponsor details
Qasr Aini Street
Cairo
-
Egypt
+20 (0)111 566 1922
ahmed_bakir77@yahoo.com
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
National Cancer Institute, Cairo University
Alternative name(s)
NCI
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Egypt
Results and Publications
Publication and dissemination plan
Planned publication in a high impact peer reviewed journal
IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Ahmed Bakir (ahmed_bakir77@yahoo.com)
Intention to publish date
10/09/2018
Participant level data
Available on request
Basic results (scientific)
Publication list
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31118760 (added 24/05/2019)