Postoperative PainNCT03749395
Ultrasound Guided Erector Spinae Block for Postoperative Analgesia in Thoracotomy Patients
A study testing Erector Spinae Plane Block in people with Postoperative Pain, run by Benha University at 1 site in Egypt.
Trial summary
aim of this study is to assess and compare between the efficacy of the new U/S guided erector spinae plane block (ESP) and the conventional methods of systemic analgesics in adult patients scheduled for elective thoracotomy surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Erector Spinae Plane Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Dec 2018to 5 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged >18 years
- American Society of Anesthesiologists Physical Status I or IV scheduled for elective thoracotomy
Who cannot join
- Refusal of the patient to provide written consent
- history of relevant drug allergy
- age less than 18
- obesity BMI > 40 kg/m2
- infection of the skin at the site of needle puncture area
- coagulopathy
- Pregnant females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Erector Spinae Block for Postoperative Analgesia in Thoracotomy Patients : A Prospective, Randomized, Observer-Blind,Controlled Clinical Trial
aim of this study is to assess and compare between the efficacy of the new U/S guided erector spinae plane block (ESP) and the conventional methods of systemic analgesics in adult patients scheduled for elective thoracotomy surgery.
Read the detailed description
Thoracotomy is considered the most painful of surgical procedures and providing effective analgesia is the onus for all anesthetists. Ineffective pain relief impedes deep breathing, coughing, and remobilization culminating in atelectasis and pneumonia.The erector spinae plane (ESP) block is a newly-described technique for treating thoracic pain, and has several advantages that make it an attractive alternative to these more invasive procedures.Ultrasound guided erector spinae (ESP) block is a regional anesthesia technique, recently described by (Forero; et al.) for use in thoracic neuropathic pain. ESP block is reported to lead to analgesic effect on somatic and visceral pain by effecting the ventral rami and rami communicantes that include sympathetic nerve fibers, as LA spreads through the paravertebral space . When performed bilaterally it has been reported to be as effective as thoracic epidural analgesia.ESP block leads to effective postoperative analgesia when performed at T 4-5 level for breast and thoracic surgery. The ESP block , will be performed as follow:The patient will be placed in a sitting position and the ultrasound probe will be placed in a longitudinal orientation 3 cm lateral to the T5 spinous process. Three muscles were identified superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae . the needle will be inserted in a cephalad-to-caudad direction until the tip lay deep to erector spinae muscles, as evidenced by visible linear spread of fluid beneath muscle upon injection . A total of 20 mL of 0.25% bupivacaine will be injected here.
- Conditions
- Postoperative Pain
- Being tested
- Erector Spinae Plane Block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockProcedure or surgery
The patient will be placed in a sitting position and the ultrasound probe will be placed in a longitudinal orientation 3 cm lateral to the T5 spinous process. Three muscles were identified superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae . the needle will be inserted in a cephalad-to-caudad direction until the tip lay deep to erector spinae muscles, as evidenced by visible linear spread of fluid beneath muscle upon injection . A total of 20 mL of 0.25% bupivacaine will be injected here.
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane Block group | Active comparator | * The Erector Spinae Plane block will be done as follow,the patient will be placed in a sitting position and the ultrasound probe will be placed in a longitudinal orientation 3 cm lateral to the T5 spinous process. Three muscles were identified superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae . the needle will be inserted in a cephalad-to-caudad direction until the tip lay deep to erector spinae muscles, as evidenced by visible linear spread of fluid beneath muscle upon injection . A total of 20 mL of 0.25% bupivacaine will be injected here.
* All patients will receive general anesthesia as described in conventional group Receives: Procedure: Erector Spinae Plane Block |
| Conventional group | No intervention | * Nothing will be injected * All patients will receive pre-oxygenation with O2 100% for 3 min. Anesthesia will be induced by using fentanyl 1μg/kg, propofol 1.5-2 mg/kg and atracurium 0.5 mg/kg will be used for muscle relaxation. Anesthesia will be maintained by controlled ventilation with oxygen and air (50:50) with target of EtCo2≈ 35-40 mmHg, isoflurane 1:1.5 minimum alveolar concentration (MAC), 0.5μg/kg fentanyl will be given intraoperative when either heart rate or Non Invasive Blood Pressure report an increase by more than 20% of the basal records. Anesthesia will be discontinued and tracheal extubation will be done once patient fulfilled the extubation criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hours morphine consumption
total morphine consumption in both groups will be assessed in the postoperative period
Measured: 24 hours postoperative
Secondary outcomes (3)
The quality of analgesia based on visual analogue scale (VAS) pain scores.
VAS score will be obtained in the postoperative period at preset time intervals.Using a ruler, the score is determined by mea-suring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.No pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
Measured: every 6 hours for 24 hours
Side effects of opioid usage
Any evidence of opioid-related morbidity or adverse effects eg. nausea,vomiting,pruritus.These effects will be assessed by questionnaire.
Measured: 2, 6, 12, 24 hours postoperative
Procedural morbidity
Any evidence of procedure-related morbidity
Measured: 2, 6, 12, 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start5 Dec 2018
- Primary completion5 Nov 2019
- Study completion5 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel arms. One group will receive erector spinae plane block, and the other will receive nothing.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohammed gomaa sobhy, Benha University
- Investigators
- faculty of medicine, Study director, faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749395
- Sponsor's protocol ID
- Erector spinae block
- Status last verified
- Aug 2020
- First submitted
- 13 Nov 2018
- Last updated
- 18 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
PubMed 27501016
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Erector Spinae Block for Postoperative Analgesia in Thoracotomy Patients : A Prospective, Randomized, Observer-Blind,Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03749395
- Acronym / sponsor ID
- Erector spinae block
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 5 Nov 2019 (actual)
- Study completion
- 5 Nov 2019 (actual)
- First posted
- 21 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
aim of this study is to assess and compare between the efficacy of the new U/S guided erector spinae plane block (ESP) and the conventional methods of systemic analgesics in adult patients scheduled for elective thoracotomy surgery.
Detailed description
Thoracotomy is considered the most painful of surgical procedures and providing effective analgesia is the onus for all anesthetists. Ineffective pain relief impedes deep breathing, coughing, and remobilization culminating in atelectasis and pneumonia.The erector spinae plane (ESP) block is a newly-described technique for treating thoracic pain, and has several advantages that make it an attractive alternative to these more invasive procedures.Ultrasound guided erector spinae (ESP) block is a regional anesthesia technique, recently described by (Forero; et al.) for use in thoracic neuropathic pain. ESP block is reported to lead to analgesic effect on somatic and visceral pain by effecting the ventral rami and rami communicantes that include sympathetic nerve fibers, as LA spreads through the paravertebral space . When performed bilaterally it has been reported to be as effective as thoracic epidural analgesia.ESP block leads to effective postoperative analgesia when performed at T 4-5 level for breast and thoracic surgery. The ESP block , will be performed as follow:The patient will be placed in a sitting position and the ultrasound probe will be placed in a longitudinal orientation 3 cm lateral to the T5 spinous process. Three muscles were identified superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae . the needle will be inserted in a cephalad-to-caudad direction until the tip lay deep to erector spinae muscles, as evidenced by visible linear spread of fluid beneath muscle upon injection . A total of 20 mL of 0.25% bupivacaine will be injected here.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel arms. One group will receive erector spinae plane block, and the other will receive nothing.
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane Block group | Active comparator | Procedure: Erector Spinae Plane Block* The Erector Spinae Plane block will be done as follow,the patient will be placed in a sitting position and the ultrasound probe will be placed in a longitudinal orientation 3 cm lateral to the T5 spinous process. Three muscles were identified superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae . the needle will be inserted in a cephalad-to-caudad direction until the tip lay deep to erector spinae muscles, as evidenced by visible linear spread of fluid beneath muscle upon injection . A total of 20 mL of 0.25% bupivacaine will be injected here. * All patients will receive general anesthesia as described in conventional group |
| Conventional group | No intervention | –* Nothing will be injected * All patients will receive pre-oxygenation with O2 100% for 3 min. Anesthesia will be induced by using fentanyl 1μg/kg, propofol 1.5-2 mg/kg and atracurium 0.5 mg/kg will be used for muscle relaxation. Anesthesia will be maintained by controlled ventilation with oxygen and air (50:50) with target of EtCo2≈ 35-40 mmHg, isoflurane 1:1.5 minimum alveolar concentration (MAC), 0.5μg/kg fentanyl will be given intraoperative when either heart rate or Non Invasive Blood Pressure report an increase by more than 20% of the basal records. Anesthesia will be discontinued and tracheal extubation will be done once patient fulfilled the extubation criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients aged >18 years
- American Society of Anesthesiologists Physical Status I or IV scheduled for elective thoracotomy
Key exclusion criteria (7 listed)
- Refusal of the patient to provide written consent
- history of relevant drug allergy
- age less than 18
- obesity BMI > 40 kg/m2
- infection of the skin at the site of needle puncture area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erector Spinae Plane BlockThe patient will be placed in a sitting position and the ultrasound probe will be placed in a longitudinal orientation 3 cm lateral to the T5 spinous process. Three muscles were identified superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae . the needle will be inserted in a cephalad-to-caudad direction until the tip lay deep to erector spinae muscles, as evidenced by visible linear spread of fluid beneath muscle upon injection . A total of 20 mL of 0.25% bupivacaine will be injected here. | Procedure or surgery | Erector Spinae Plane Block group |
Primary outcome
24 hours morphine consumption
Time frame: 24 hours postoperative
total morphine consumption in both groups will be assessed in the postoperative period
3 secondary outcomes
The quality of analgesia based on visual analogue scale (VAS) pain scores.
Time frame: every 6 hours for 24 hours
Side effects of opioid usage
Time frame: 2, 6, 12, 24 hours postoperative
Procedural morbidity
Time frame: 2, 6, 12, 24 hours postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Background: PubMed 27501016Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
faculty of medicine study director
faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector Spinae Plane Block in people with Postoperative Pain, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 hours morphine consumption (time frame: 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03749395, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2020.