Condition category
Surgery
Date applied
12/04/2017
Date assigned
19/04/2017
Last edited
19/04/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes