StressNCT06064214
Intermediate Cervical Plexus Block on Stress Response
A study testing u/s guided intermediate cervical plexus block in people with Stress, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of the present study is to investigate the effect of Bilateral Ultrasound-Guided intermediate cervical plexus Block combined with general anesthesia on the stress and inflammatory response in patients undergoing anterior cervical spine surgery (ACSS) Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- u/s guided intermediate cervical plexus block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Dec 2024
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. ASA I \& ASA II patients.(The American Society of Anesthesiologists) 2. Age group: from 18 to 65 years old. 3. Patients undergoing anterior cervical discectomy or fixation. 4. Genders eligible for study: both sexes
Who cannot join
- • Patient refusal.
- Patient Undergoing posterior fixation in addition to anterior.
- An allergy to local anaesthetics.
- Infection at block puncture site.
- Bleeding disorders (Coagulopathy: PTT(partial thromboplastin time) > 40seconds, INR(international normalised ratio) > 1.2, platelet count < 120 x 103 / L.).
- Emergency surgeries \& patients in sepsis
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahmed Raafat
Giza, October, 002
gomaa dr zohrey, md, 01278996596 ext. 02, gomaneel@icloud.com
ahmed dr ragab, md, 01119003377 ext. 02, ahmedtr.taha@gmail.com
About this study
Official title: Effect of Bilateral Ultrasound-Guided Intermediate Cervical Plexus Block Combined With General Anesthesia on THE Stress Response in Patients Undergoing Anterior Cervical Spine Surgery. A Randomized Controlled Study
The aim of the present study is to investigate the effect of Bilateral Ultrasound-Guided intermediate cervical plexus Block combined with general anesthesia on the stress and inflammatory response in patients undergoing anterior cervical spine surgery (ACSS)
Read the detailed description
Stress response is the name given to the hormonal and metabolic changes which follow injury or trauma. It may lead to changes in the nervous, endocrine and immune systems, and alterations in metabolic processes and functions. The stress response can shift from an adaptive and protective role to a pathogenic occurrence, especially when it is strong and chronic.
Stress hormones, the most prevalent of which is cortisol, have a circadian pattern in which they gradually climb after night sleep to reach a peak at early morning wake-up time, then gradually decline as the day progresses .
This pattern, however, can be disrupted by any stressful situation, such as severe pain from surgery, which has been linked to a progressive rise in cortisol levels both intraoperatively and in the early postoperative period.
Cytokines are group of low molecular weight proteins that modulate the systemic inflammatory response elicited by surgical intervention. Increased levels of proinflammatory cytokines, including interleukin-6 (IL-6) which is the main cytokine responsible for inducing the systemic changes, is an early features of acute injury. Interleukin-6 could be a good marker for research purposes that reflects and compares postoperative stress levels.
Spine surgeries are increasingly being performed as short-stay surgical procedures, and anterior cervical decompression and fusion is one such procedure .Postoperative incisional pain has been described as moderate in intensity, requiring opioid analgesics in most cases. Nonetheless, opioid-related side effects such as nausea, vomiting, and respiratory depression are undesirable in these patients who are at risk for airway problems due to surgical retraction or wound hematoma.
Regional anesthesia inhibits the stress response to surgery and can also influence postoperative outcomes. . The endocrinal stress response to the surgical operation is reduced as a result of inhibiting afferent impulses from the surgical site. Furthermore, a reduction in this type of stress response is seen as a key indicator of a successful regional block.
Intermediate cervical plexus block (CPB) is a safe and simple technique that has been shown to provide good pain relief through blocking all four cutaneous branches of the cervical plexus, as well as sensory and motor branches .Not only Intermediate (CPB) is superior to superficial CPB in terms of effectiveness, but also is safer than deep (CPB) .
There is a paucity of evidence for the effect of bilateral cervical plexus block for anterior cervical spine surgeries. Prior research had employed recovery questionnaire score, 24-h opioid usage and length of hospital stay in assessment of cervical plexus block effectiveness , however estimating the effect of Intermediate (CPB) on stress biomarkers as serum cortisol and interleukien-6 has not been discussed yet
- Conditions
- Stress
- Being tested
- u/s guided intermediate cervical plexus block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
u/s guided intermediate cervical plexus blockProcedure or surgery
The patient will be placed in supine position,u/s probe is placed on the lateral neck, overlying the sternomastoid muscle at the level of its midpoint , Once the SCM has been identified, the transducer is moved posteriorly until the tapering posterior edge is positioned in the middle of the screen.cervical plexus is visible as a small collection of hypoechoic nodules ( immediately superficial to the prevertebral fascia the needle is passed through the skin, platysma, and investing layer of the deep cervical fascia, and the tip is placed adjacent to the plexus,bupivicaine 0.25% (5-15 mL) is administered to envelop the plexus
| Study group | Role | What they receive |
|---|---|---|
| block | Experimental | 33 patients will receive bilateral u/s guided intermediate cervical plexus block with general anesthesia Receives: Procedure: u/s guided intermediate cervical plexus block |
| morphine | Active comparator | 33 patients will receive morphine in a dose of 0.1-0.2 mg/kg to maintain intraoperative analgesia Receives: Procedure: u/s guided intermediate cervical plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
• The serum cortisol level 24 hours postoperatively
All operations will be performed in the morning, taking into consideration circadian rhythm of hormone release. In both groups, venous blood samples to measure serum cortisol level will be collected before surgery as a baseline, then 24 hours post-operative
Measured: pre operative and after 24 hours of operation
Secondary outcomes (1)
• The serum interleukien-6 24 hours postoperatively
All operations will be performed in the morning, taking into consideration circadian rhythm of hormone release. In both groups, venous blood samples to measure serum cortisol and interleukien-6 level will be collected before surgery as a baseline, then 24 hours post-operative.interleukien-6 is normally low and may be undetectable within 30-60 min after start of surgery while reaching maximum level at 24 hours post-operative
Measured: pre operative and after 24 hours of operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start1 Jan 2024
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Cairo 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
- randomized controlled study
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed raafat taha abd el aziz, Cairo University
- Investigators
- gomaa zohry, professor, Principal investigator, cairo universitey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064214
- Sponsor's protocol ID
- cervical plexus block
- Status last verified
- Jan 2024
- First submitted
- 19 Sep 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bilateral Ultrasound-Guided Intermediate Cervical Plexus Block Combined With General Anesthesia on THE Stress Response in Patients Undergoing Anterior Cervical Spine Surgery. A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06064214
- Acronym / sponsor ID
- cervical plexus block
- Conditions
- Stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 3 Oct 2023 (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.
The aim of the present study is to investigate the effect of Bilateral Ultrasound-Guided intermediate cervical plexus Block combined with general anesthesia on the stress and inflammatory response in patients undergoing anterior cervical spine surgery (ACSS)
Detailed description
Stress response is the name given to the hormonal and metabolic changes which follow injury or trauma. It may lead to changes in the nervous, endocrine and immune systems, and alterations in metabolic processes and functions. The stress response can shift from an adaptive and protective role to a pathogenic occurrence, especially when it is strong and chronic.
Stress hormones, the most prevalent of which is cortisol, have a circadian pattern in which they gradually climb after night sleep to reach a peak at early morning wake-up time, then gradually decline as the day progresses .
This pattern, however, can be disrupted by any stressful situation, such as severe pain from surgery, which has been linked to a progressive rise in cortisol levels both intraoperatively and in the early postoperative period.
Cytokines are group of low molecular weight proteins that modulate the systemic inflammatory response elicited by surgical intervention. Increased levels of proinflammatory cytokines, including interleukin-6 (IL-6) which is the main cytokine responsible for inducing the systemic changes, is an early features of acute injury. Interleukin-6 could be a good marker for research purposes that reflects and compares postoperative stress levels.
Spine surgeries are increasingly being performed as short-stay surgical procedures, and anterior cervical decompression and fusion is one such procedure .Postoperative incisional pain has been described as moderate in intensity, requiring opioid analgesics in most cases. Nonetheless, opioid-related side effects such as nausea, vomiting, and respiratory depression are undesirable in these patients who are at risk for airway problems due to surgical retraction or wound hematoma.
Regional anesthesia inhibits the stress response to surgery and can also influence postoperative outcomes. . The endocrinal stress response to the surgical operation is reduced as a result of inhibiting afferent impulses from the surgical site. Furthermore, a reduction in this type of stress response is seen as a key indicator of a successful regional block.
Intermediate cervical plexus block (CPB) is a safe and simple technique that has been shown to provide good pain relief through blocking all four cutaneous branches of the cervical plexus, as well as sensory and motor branches .Not only Intermediate (CPB) is superior to superficial CPB in terms of effectiveness, but also is safer than deep (CPB) .
There is a paucity of evidence for the effect of bilateral cervical plexus block for anterior cervical spine surgeries. Prior research had employed recovery questionnaire score, 24-h opioid usage and length of hospital stay in assessment of cervical plexus block effectiveness , however estimating the effect of Intermediate (CPB) on stress biomarkers as serum cortisol and interleukien-6 has not been discussed yet
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| block | Experimental | Procedure: u/s guided intermediate cervical plexus block33 patients will receive bilateral u/s guided intermediate cervical plexus block with general anesthesia |
| morphine | Active comparator | Procedure: u/s guided intermediate cervical plexus block33 patients will receive morphine in a dose of 0.1-0.2 mg/kg to maintain intraoperative analgesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. ASA I \& ASA II patients.(The American Society of Anesthesiologists) 2. Age group: from 18 to 65 years old. 3. Patients undergoing anterior cervical discectomy or fixation. 4. Genders eligible for study: both sexes
Key exclusion criteria (6 listed)
- • Patient refusal.
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 |
|---|---|---|
| u/s guided intermediate cervical plexus blockThe patient will be placed in supine position,u/s probe is placed on the lateral neck, overlying the sternomastoid muscle at the level of its midpoint , Once the SCM has been identified, the transducer is moved posteriorly until the tapering posterior edge is positioned in the middle of the screen.cervical plexus is visible as a small collection of hypoechoic nodules ( immediately superficial to the prevertebral fascia the needle is passed through the skin, platysma, and investing layer of the deep cervical fascia, and the tip is placed adjacent to the plexus,bupivicaine 0.25% (5-15 mL) is administered to envelop the plexus | Procedure or surgery | block, morphine |
Primary outcome
• The serum cortisol level 24 hours postoperatively
Time frame: pre operative and after 24 hours of operation
All operations will be performed in the morning, taking into consideration circadian rhythm of hormone release. In both groups, venous blood samples to measure serum cortisol level will be collected before surgery as a baseline, then 24 hours post-operative
1 secondary outcome
• The serum interleukien-6 24 hours postoperatively
Time frame: pre operative and after 24 hours of operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Individual participant dataSharing planned: Yes
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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.
gomaa zohry, professor principal investigator
cairo universitey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing u/s guided intermediate cervical plexus block in people with Stress, run by Cairo 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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 23 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ahmed raafat, master's (01278996596, ahmedtaha840@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• The serum cortisol level 24 hours postoperatively (time frame: pre operative and after 24 hours of operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2024.