Efficiency of Using Ultrasound-guided SCB for Providing Intra and Postoperative Analgesiatracheal Reconstruction SurgeryNCT04567992
Efficacy of Ultrasound Guided Superficial Cervical Plexus Block for Tracheal Reconstruction Surgery:
A study testing superficial cervical plexus block in people with Efficiency of Using Ultrasound-guided SCB for Providing Intra and Postoperative Analgesiatracheal Reconstruction Surgery, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
The essential goal for tracheal reconstruction is is the ability of the anaesthesiologist and surgeon to maintain control of the airway at all times. In the postoperative period the patient should maintain a flexed neck position to avoid any traction on the tracheal anastomosis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Efficiency of Using Ultrasound-guided SCB for Providing Intra and Postoperative Analgesiatracheal Reconstruction Surgery
- What is being tested?
- superficial cervical plexus block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2020to 1 Mar 2021
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA physical status I, II, and III adult patients undergoing elective tracheal resection and anastomosis under general anaesthesia were included.
Who cannot join
- Coagulation disorders
- Pregnancy.
- Age less than 18 years.
- Patient refusal.
- Emergency re-operation within
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Ultrasound Guided Superficial Cervical Plexus Block for Tracheal Reconstruction Surgery on Quality of Recovery: a Randomized Control Study
The essential goal for tracheal reconstruction is is the ability of the anaesthesiologist and surgeon to maintain control of the airway at all times. In the postoperative period the patient should maintain a flexed neck position to avoid any traction on the tracheal anastomosis. Thus, pain control is essential postoperatively so that patients will be awake and cooperative to maintain this position. [1].
Superficial cervical plexus block can be used in a variety of surgical procedures , including superficial surgery on the neck and shoulders and thyroid surgery as it results in anesthesia of the skin of the anterolateral neck and the ante-auricular and retro-auricular areas, as well as the skin overlying and immediately inferior to the clavicle on the chest wall Figures 1 and 6)[2].
Read more
Thus it can be used as an adjuvant to general anaesthesia to provide analgesia for patients undergoing tracheal resection and anastomosis to keep the patients awake and cooperative at the conclusion of the procedure.
The goal of the ultrasound (US)-guided technique of SCB is to deposit local anesthetic within the vicinity of the sensory branches of the nerve roots C2, C3, and C4 which combine to form the four terminal branches (the lesser occipital, greater auricular, transverse cervical, and supraclavicular nerves) and emerge from behind the posterior border of the SCM. Advantages over the landmark-based technique include the ability to visualize the spread of local anesthetic in the correct plane, which therefore increases the success rate, and to avoid a needle insertion that is too deep and the inadvertent puncture of neighboring structures[3].
Aim of the work To assess the efficiency of using ultrasound-guided SCB for providing intra and postoperative analgesia for patients undergoing tracheal resection and anastomosis under general anaesthesia.
- Being tested
- superficial cervical plexus block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
superficial cervical plexus blockProcedure or surgery
Also called Drug:, Bupivicaine
ultrasound guided injection of local anaesthesia in the superficial cervical plexus
| Study group | Role | What they receive |
|---|---|---|
| SCPB | Experimental | Not described Receives: Procedure: superficial cervical plexus block |
| Control | Placebo comparator | Not described Receives: Procedure: superficial cervical plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of recovery using quality of recovery 40 qusetionnaire
total score of Qor-40 (total score of 200) with highest indicates better outcome
Measured: first 24 hour
Secondary outcomes (2)
post operative morphine consumption
post operative morphine consumption
Measured: 24 hour
visual analogue scale post-operative
visual analogue scale post-operative
Measured: first 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start1 Nov 2020
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Efficiency of Using Ultrasound-guided SCB for Providing Intra and Postoperative Analgesiatracheal Reconstruction SurgeryStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Abougabal, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567992
- Sponsor's protocol ID
- MS-106-2020
- Status last verified
- Oct 2020
- First submitted
- 24 Sep 2020
- Last updated
- 14 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ultrasound Guided Superficial Cervical Plexus Block for Tracheal Reconstruction Surgery on Quality of Recovery: a Randomized Control Study
- ClinicalTrials.gov ID
- NCT04567992
- Acronym / sponsor ID
- MS-106-2020
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 29 Sep 2020 (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 essential goal for tracheal reconstruction is is the ability of the anaesthesiologist and surgeon to maintain control of the airway at all times. In the postoperative period the patient should maintain a flexed neck position to avoid any traction on the tracheal anastomosis. Thus, pain control is essential postoperatively so that patients will be awake and cooperative to maintain this position. [1].
Superficial cervical plexus block can be used in a variety of surgical procedures , including superficial surgery on the neck and shoulders and thyroid surgery as it results in anesthesia of the skin of the anterolateral neck and the ante-auricular and retro-auricular areas, as well as the skin overlying and immediately inferior to the clavicle on the chest wall Figures 1 and 6)[2].
Thus it can be used as an adjuvant to general anaesthesia to provide analgesia for patients undergoing tracheal resection and anastomosis to keep the patients awake and cooperative at the conclusion of the procedure.
The goal of the ultrasound (US)-guided technique of SCB is to deposit local anesthetic within the vicinity of the sensory branches of the nerve roots C2, C3, and C4 which combine to form the four terminal branches (the lesser occipital, greater auricular, transverse cervical, and supraclavicular nerves) and emerge from behind the posterior border of the SCM. Advantages over the landmark-based technique include the ability to visualize the spread of local anesthetic in the correct plane, which therefore increases the success rate, and to avoid a needle insertion that is too deep and the inadvertent puncture of neighboring structures[3].
Aim of the work To assess the efficiency of using ultrasound-guided SCB for providing intra and postoperative analgesia for patients undergoing tracheal resection and anastomosis under general anaesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCPB | Experimental | Procedure: superficial cervical plexus block |
| Control | Placebo comparator | Procedure: superficial cervical plexus block |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA physical status I, II, and III adult patients undergoing elective tracheal resection and anastomosis under general anaesthesia were included.
Key exclusion criteria (5 listed)
- Coagulation disorders
- Pregnancy.
- Age less than 18 years.
- Patient refusal.
- Emergency re-operation within
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 |
|---|---|---|
| superficial cervical plexus blockAlso: Drug:, Bupivicaineultrasound guided injection of local anaesthesia in the superficial cervical plexus | Procedure or surgery | Control, SCPB |
Primary outcome
quality of recovery using quality of recovery 40 qusetionnaire
Time frame: first 24 hour
total score of Qor-40 (total score of 200) with highest indicates better outcome
2 secondary outcomes
post operative morphine consumption
Time frame: 24 hour
visual analogue scale post-operative
Time frame: first 24 hour
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 14 Feb 2022.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing superficial cervical plexus block in people with Efficiency of Using Ultrasound-guided SCB for Providing Intra and Postoperative Analgesiatracheal Reconstruction Surgery, run by Kasr El Aini Hospital 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 5 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 14 Feb 2022. 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. Some participants in this study may receive a placebo. 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?
quality of recovery using quality of recovery 40 qusetionnaire (time frame: first 24 hour). 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 14 Feb 2022.