Tracheal ReconstructionNCT03426527
Dexmedetomidine for Bilateral Superficial Cervical Plexus Block for Reconstructive Tracheal Surgery
A study testing Levobupivacaine, Levobupivacaine-Dexmedetomidine and General Anaesthesia in people with Tracheal Reconstruction, run by Mansoura University at 1 site in Egypt.
Trial summary
Tracheal resection and reconstruction (TRR) is the treatment of choice for most patients with tracheal stenosis or tracheal tumors .The post intubation tracheal stenosis is the common indication for (TRR).The immediate postoperative period can be anxiety provoking for some reasons such as requirement to maintain a… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Tracheal Reconstruction
- What is being tested?
- Levobupivacaine, Levobupivacaine-Dexmedetomidine and General Anaesthesia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2018to 1 Oct 2018
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists physical status I or II.
Who cannot join
- History of allergy to the drugs used
- Coagulation disorders
- Pregnancy
- Postpartum period.
- Lactating females
- Local sepsis
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University, Central Hospital, Oto-Rhino-Laryngology anesthesia Unit
Al Mansurah, DK, 050
About this study
Official title: Levobupivacaine Versus Levobupivacaine - Dexmedetomidine for Ultrasound Guided Bilateral Superficial Cervical Plexus Block for Upper Tracheal Resection and Reconstruction Surgery Under General Anesthesia
Tracheal resection and reconstruction (TRR) is the treatment of choice for most patients with tracheal stenosis or tracheal tumors .The post intubation tracheal stenosis is the common indication for (TRR).The immediate postoperative period can be anxiety provoking for some reasons such as requirement to maintain a flexed neck, oxygen mask, and surgical pain which inadequately treated.
Bilateral superficial cervical plexus block (BSCPB) is a popular regional anesthesia technique for its feasibility and efficacy. The use of regional anesthesia in combination with general anesthesia may lighten the level of general anesthesia required , provide prolonged postoperative analgesia and reduce the requirements for opioid analgesics
Read more
Dexmedetomidine is a highly selective α2 agonist with high affinity for α2 adrenergic receptors and less α1 effects, which is responsible for the hypnotic and analgesic effects. Previous trials demonstrated that perineural dexmedetomidine in combination with bupivacaine enhanced sensory and motor block ,without neurotoxicity ,in both experimental and clinical studies.
Levobupivacaine, is "S"-enantiomer of bupivacaine, has strongly emerged as a safer alternative for regional anesthesia than bupivacaine . Levobupivacaine has been found to be equally efficacious as bupivacaine, but with a superior pharmacokinetic profile.
Clinically, levobupivacaine has been observed to be well tolerated in regional anesthesia techniques both after bolus administration and continuous post-operative infusion.
Read the detailed description
The aim of this study is to evaluate the intra- and postoperative efficacy of levobupivacaine versus levobupivacaine - dexmedetomidine for superficial cervical plexus block for upper tracheal resection and reconstruction surgery.
- Conditions
- Tracheal Reconstruction
- Being tested
- Levobupivacaine, Levobupivacaine-Dexmedetomidine, General Anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevobupivacaineDrug
Following induction of anaesthesia, patients will receive ultrasound guided bilateral superficial cervical plexus block with levobupivacaine
Levobupivacaine-DexmedetomidineDrug
Following induction of anaesthesia, patients will receive ultrasound guided bilateral superficial cervical plexus block with levobupivacaine in conjunction with dexmedetomidine
General AnaesthesiaOther
Using propofol, fentanyl and atracurium
| Study group | Role | What they receive |
|---|---|---|
| Levobupivacaine | Placebo comparator | Patients will receive bilateral superficial cervical plexus block using levobupivacaine General anesthesia Receives: Drug: Levobupivacaine; Other: General Anaesthesia |
| Levobupivacaine-Dexmedetomidine | Active comparator | Patients will receive bilateral superficial cervical plexus block using levobupivacaine-dexmedetomidine General anesthesia Receives: Drug: Levobupivacaine-Dexmedetomidine; Other: General Anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative postoperative opioid consumption
Total postoperative opioid consumption
Measured: For 24 hours after surgery
Secondary outcomes (8)
Systolic blood pressure
Perioperative changes in systolic blood pressure
Measured: Before and for 6 hours after start of anaesthesia
Diastolic blood pressure
Perioperative changes in diastolic blood pressure
Measured: Before and for 6 hours after start of anaesthesia
Heart rate
Perioperative changes in heart rate
Measured: Before and for 6 hours after start of anaesthesia
Peripheral oxygen saturation
Perioperative changes in peripheral oxygen saturation
Measured: Before and for 6 hours after start of anaesthesia
End-tidal carbon dioxide tension
Perioperative changes in end-tidal carbon dioxide tension
Measured: Before and for 6 hours after start of anaesthesia
Time for first analgesic request of analgesia following extubation
Time to receiving the rescue analgesic following surgery
Measured: For 24 hours after surgery
Pain scores
Using visual analogue score (it is 100 mm unmarked line in which 0 = no pain and 100 = worst pain),score >30 mm needs rescue analgesics
Measured: For 24 hours after surgery
Cortisol serum level
Perioperative changes in cortisol level
Measured: before induction of anaesthesia , one hour after the block then one hour after recovery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start1 Mar 2018
- Primary completion1 Sep 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheal ReconstructionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Salwa MS Hayes, MD, Study chair, Assistant Professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03426527
- Sponsor's protocol ID
- R/17.09.19
- Status last verified
- Sep 2020
- First submitted
- 31 Jan 2018
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levobupivacaine Versus Levobupivacaine - Dexmedetomidine for Ultrasound Guided Bilateral Superficial Cervical Plexus Block for Upper Tracheal Resection and Reconstruction Surgery Under General Anesthesia
- ClinicalTrials.gov ID
- NCT03426527
- Acronym / sponsor ID
- R/17.09.19
- Conditions
- Tracheal Reconstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 8 Feb 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.
Tracheal resection and reconstruction (TRR) is the treatment of choice for most patients with tracheal stenosis or tracheal tumors .The post intubation tracheal stenosis is the common indication for (TRR).The immediate postoperative period can be anxiety provoking for some reasons such as requirement to maintain a flexed neck, oxygen mask, and surgical pain which inadequately treated.
Bilateral superficial cervical plexus block (BSCPB) is a popular regional anesthesia technique for its feasibility and efficacy. The use of regional anesthesia in combination with general anesthesia may lighten the level of general anesthesia required , provide prolonged postoperative analgesia and reduce the requirements for opioid analgesics
Dexmedetomidine is a highly selective α2 agonist with high affinity for α2 adrenergic receptors and less α1 effects, which is responsible for the hypnotic and analgesic effects. Previous trials demonstrated that perineural dexmedetomidine in combination with bupivacaine enhanced sensory and motor block ,without neurotoxicity ,in both experimental and clinical studies.
Levobupivacaine, is "S"-enantiomer of bupivacaine, has strongly emerged as a safer alternative for regional anesthesia than bupivacaine . Levobupivacaine has been found to be equally efficacious as bupivacaine, but with a superior pharmacokinetic profile.
Clinically, levobupivacaine has been observed to be well tolerated in regional anesthesia techniques both after bolus administration and continuous post-operative infusion.
Detailed description
The aim of this study is to evaluate the intra- and postoperative efficacy of levobupivacaine versus levobupivacaine - dexmedetomidine for superficial cervical plexus block for upper tracheal resection and reconstruction surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levobupivacaine | Placebo comparator | Drug: Levobupivacaine, Other: General AnaesthesiaPatients will receive bilateral superficial cervical plexus block using levobupivacaine General anesthesia |
| Levobupivacaine-Dexmedetomidine | Active comparator | Drug: Levobupivacaine-Dexmedetomidine, Other: General AnaesthesiaPatients will receive bilateral superficial cervical plexus block using levobupivacaine-dexmedetomidine General anesthesia |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists physical status I or II.
Key exclusion criteria (6 listed)
- History of allergy to the drugs used
- Coagulation disorders
- Pregnancy
- Postpartum period.
- Lactating females
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 |
|---|---|---|
| LevobupivacaineFollowing induction of anaesthesia, patients will receive ultrasound guided bilateral superficial cervical plexus block with levobupivacaine | Drug | Levobupivacaine |
| Levobupivacaine-DexmedetomidineFollowing induction of anaesthesia, patients will receive ultrasound guided bilateral superficial cervical plexus block with levobupivacaine in conjunction with dexmedetomidine | Drug | Levobupivacaine-Dexmedetomidine |
| General AnaesthesiaUsing propofol, fentanyl and atracurium | Other | Levobupivacaine, Levobupivacaine-Dexmedetomidine |
Primary outcome
Cumulative postoperative opioid consumption
Time frame: For 24 hours after surgery
Total postoperative opioid consumption
8 secondary outcomes
Systolic blood pressure
Time frame: Before and for 6 hours after start of anaesthesia
Diastolic blood pressure
Time frame: Before and for 6 hours after start of anaesthesia
Heart rate
Time frame: Before and for 6 hours after start of anaesthesia
Peripheral oxygen saturation
Time frame: Before and for 6 hours after start of anaesthesia
End-tidal carbon dioxide tension
Time frame: Before and for 6 hours after start of anaesthesia
Time for first analgesic request of analgesia following extubation
Time frame: For 24 hours after surgery
Pain scores
Time frame: For 24 hours after surgery
Cortisol serum level
Time frame: before induction of anaesthesia , one hour after the block then one hour after recovery
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 11 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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.
Salwa MS Hayes, MD study chair
Assistant Professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levobupivacaine, Levobupivacaine-Dexmedetomidine and General Anaesthesia in people with Tracheal Reconstruction, run by Mansoura 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: finished, as of the sponsor's last update on 11 Sep 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. 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?
Cumulative postoperative opioid consumption (time frame: For 24 hours after surgery). 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 11 Sep 2020.