Ultrasound guided continous serratus anterior plane block: dexmedetomidine as an adjunctive analgesic with levobupivacine for post thoracotomy pain

ISRCTN ISRCTN35517318
DOI https://doi.org/10.1186/ISRCTN35517318
Secondary identifying numbers 201617011.2p
Submission date
12/04/2017
Registration date
19/04/2017
Last edited
24/05/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Ahmed Bakeer
Scientific

Cairo University
Cairo
-
Egypt

Phone +20 (0)111 566 1922
Email ahmed_bakir77@yahoo.com

Study information

Study designInterventional prospective randomized controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet No participant information sheet available
Scientific titleUltrasound guided continous serratus anterior plane block :dexmedetomidine as an adjunctive analgesic with levobupivacine for post thoracotomy pain: a prospective randomized controlled study
Study objectivesDexmedetomidine 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(s)Ethics committee of National Cancer Institute, Cairo University, 04/04/2017, ref: 201617011.2b
Health condition(s) or problem(s) studiedPost-thoracotomy pain
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Levobupivacaine, dexmedetomidine
Primary outcome measurePostoperative 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 measures1. 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 study start date10/03/2017
Completion date10/09/2017

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants25 patients in each group
Total final enrolment50
Key inclusion criteria1. Age from 20-60
2. ASA 2 or 3
3. Undergoing elective thoracic surgery
Key exclusion criteria1. Refusal of the patient
2. Coagulopathy
3. Severe cardiac or renal impairment or hepatic disease
4. Known allergy to the study drugs
Date of first enrolment10/04/2017
Date of final enrolment10/08/2017

Locations

Countries of recruitment

  • Egypt

Study participating centre

National Cancer Institute, Cairo University
-
Egypt

Sponsor information

National Cancer Institute, Cairo University
University/education

Qasr Aini Street
Cairo
-
Egypt

Phone +20 (0)111 566 1922
Email ahmed_bakir77@yahoo.com
ROR logo "ROR" https://ror.org/03q21mh05

Funders

Funder type

University/education

National Cancer Institute, Cairo University
Government organisation / National government
Alternative name(s)
NCI
Location
Egypt

Results and Publications

Intention to publish date10/09/2018
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high impact peer reviewed journal
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from Dr Ahmed Bakir (ahmed_bakir77@yahoo.com)

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 30/04/2019 24/05/2019 Yes No

Editorial Notes

24/05/2019: Publication reference and total final enrolment added.