Upper Tracheal ResectionNCT02949661
Local Wound Infiltration for Tracheal Reconstruction
A study testing Superficial cervical plexus block and Local wound infiltration in people with Upper Tracheal Resection and Tracheal Reconstruction Surgery, run by Mansoura University.
Trial summary
Tracheal resection and reconstruction (TRR) is the treatment of choice for most patients with tracheal stenosis or tracheal tumors .The postintubation 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
- Upper Tracheal Resection, Tracheal Reconstruction Surgery
- What is being tested?
- Superficial cervical plexus block and Local wound infiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to May 2017
- 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 class status I or II
- Undergoing elective upper tracheal resection and reconstruction surgery
Who cannot join
- Age less than18 years
- Patients with preoperative medication included opioid
- History of allergy to the drugs used
- Coagulation disorders
- Pregnancy
- Patient refusal
- Local sepsis
- Inability to understand the study protocol or pain scale.
About this study
Official title: Local Wound Infiltration Versus Bilateral Superficial Cervical Plexus Block With Levobupivacaine 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 postintubation 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
Local anesthetic infiltration into the surgical incision can relieve pain at the wound site after surgery, as part of multimodal analgesic approach.
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 local wound infiltration versus bilateral superficial cervical plexus block with levobupivacaine for upper tracheal resection and reconstruction surgery.
- Being tested
- Superficial cervical plexus block, Local wound infiltration
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
Patients will receive bilateral superficial cervical plexus block
Local wound infiltrationProcedure or surgery
Patients will receive local wound infiltration
| Study group | Role | What they receive |
|---|---|---|
| Superficial cervical plexus block | Experimental | Patients will receive bilateral superficial cervical plexus block using levobupivacaine Receives: Procedure: Superficial cervical plexus block |
| Local wound infiltration | Active comparator | Patients will receive local wound infiltration with levobupivacaine after the conclusion of surgery Receives: Procedure: Local wound infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain score
Postoperative pain scores will be assessed using postoperative visual analogue score
Measured: For 24 hours after surgery
Secondary outcomes (9)
Systolic blood pressure
Measured: For 4 hours after start of surgery
Diastolic blood pressure
Measured: For 4 hours after start of surgery
Heart rate
Measured: For 4 hours after start of surgery
Peripheral oxygen saturation
Measured: For 4 hours after start of surgery
End-tidal Carbon dioxide tension
Measured: For 4 hours after start of surgery
Bispectral index
Measured: For 4 hours after start of surgery
Duration of analgesia
It is defined as time taken for first analgesic request of analgesia from extubation
Measured: For 24 hours after surgery
Cumulative analgesic consumption
total analgesics used for 24 hrs after surgery
Measured: For 24 hours after surgery
Cortisol serum
Plasma cortisol assay
Measured: before induction ,one hour after start of surgery and one hour after end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study startSep 2016 (estimated)
- Primary completionMar 2017 (estimated)
- Study completionMay 2017 (estimated)
Why it stopped: Loss of interest in the subject
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Tracheal ResectionStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hanaa M Elbendary, MD, Study chair, Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02949661
- Sponsor's protocol ID
- R ∕16.08.18
- Status last verified
- Sep 2020
- First submitted
- 27 Oct 2016
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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
- Local Wound Infiltration Versus Bilateral Superficial Cervical Plexus Block With Levobupivacaine for Upper Tracheal Resection and Reconstruction Surgery Under General Anesthesia.
- ClinicalTrials.gov ID
- NCT02949661
- Acronym / sponsor ID
- R ∕16.08.18
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Loss of interest in the subject
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Sep 2016 (estimated)
- Primary completion
- Mar 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 31 Oct 2016 (estimated)
- 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 postintubation 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
Local anesthetic infiltration into the surgical incision can relieve pain at the wound site after surgery, as part of multimodal analgesic approach.
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 local wound infiltration versus bilateral superficial cervical plexus block with levobupivacaine for upper tracheal resection and reconstruction surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Superficial cervical plexus block | Experimental | Procedure: Superficial cervical plexus blockPatients will receive bilateral superficial cervical plexus block using levobupivacaine |
| Local wound infiltration | Active comparator | Procedure: Local wound infiltrationPatients will receive local wound infiltration with levobupivacaine after the conclusion of surgery |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists physical class status I or II
- Undergoing elective upper tracheal resection and reconstruction surgery
Key exclusion criteria (8 listed)
- Age less than18 years
- Patients with preoperative medication included opioid
- History of allergy to the drugs used
- Coagulation disorders
- Pregnancy
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 blockPatients will receive bilateral superficial cervical plexus block | Procedure or surgery | Superficial cervical plexus block |
| Local wound infiltrationPatients will receive local wound infiltration | Procedure or surgery | Local wound infiltration |
Primary outcome
Postoperative pain score
Time frame: For 24 hours after surgery
Postoperative pain scores will be assessed using postoperative visual analogue score
9 secondary outcomes
Systolic blood pressure
Time frame: For 4 hours after start of surgery
Diastolic blood pressure
Time frame: For 4 hours after start of surgery
Heart rate
Time frame: For 4 hours after start of surgery
Peripheral oxygen saturation
Time frame: For 4 hours after start of surgery
End-tidal Carbon dioxide tension
Time frame: For 4 hours after start of surgery
Bispectral index
Time frame: For 4 hours after start of surgery
Duration of analgesia
Time frame: For 24 hours after surgery
Cumulative analgesic consumption
Time frame: For 24 hours after surgery
Cortisol serum
Time frame: before induction ,one hour after start of surgery and one hour after end of surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
- Individual participant dataSharing planned: Undecided
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.
Hanaa M Elbendary, MD study chair
Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt
Questions about this trial
What is this clinical trial studying?
A study testing Superficial cervical plexus block and Local wound infiltration in people with Upper Tracheal Resection and Tracheal Reconstruction Surgery, run by Mansoura University.
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 8 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: withdrawn, 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.
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 was withdrawn before enrolling participants, so there are no results.
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?
Postoperative pain score (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.