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
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
Scientific
Cairo University
Cairo
-
Egypt
| Phone | +20 (0)111 566 1922 |
|---|---|
| ahmed_bakir77@yahoo.com |
Study information
| Study design | Interventional prospective randomized controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| 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 |
| Study objectives | 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(s) | Ethics committee of National Cancer Institute, Cairo University, 04/04/2017, ref: 201617011.2b |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 10/03/2017 |
| Completion date | 10/09/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 25 patients in each group |
| Total final enrolment | 50 |
| Key inclusion criteria | 1. Age from 20-60 2. ASA 2 or 3 3. Undergoing elective thoracic surgery |
| Key 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 |
| Date of first enrolment | 10/04/2017 |
| Date of final enrolment | 10/08/2017 |
Locations
Countries of recruitment
- Egypt
Study participating centre
Egypt
Sponsor information
University/education
Qasr Aini Street
Cairo
-
Egypt
| Phone | +20 (0)111 566 1922 |
|---|---|
| ahmed_bakir77@yahoo.com | |
"ROR" |
https://ror.org/03q21mh05 |
Funders
Funder type
University/education
Government organisation / National government
- Alternative name(s)
- NCI
- Location
- Egypt
Results and Publications
| Intention to publish date | 10/09/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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) |
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.
