Surgical FieldPhase 4NCT06381401
Bupivacaine 0.125% Versus Bupivacaine 0.25% in Superficial Cervical Plexus Block for Tympanomastoid Surgeries in Adults
A Phase 4 study testing bupivacaine 0.25% and bupivacaine 0.125% in people with Surgical Field and Acute Postoperative Pain, run by Cairo University at 1 site in Egypt.
Trial summary
Bleeding is one of the most common complications in tympanomastoid surgery that could prolong the time of operation and also might lead to morbidity. Pain is also one of the most annoying complications of tympanomastoid surgeries. Thus, adequate surgical field visualization is utmost important. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Surgical Field, Acute Postoperative Pain
- What is being tested?
- bupivacaine 0.25% and bupivacaine 0.125%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to 5 Jul 2024
- Phase
- Phase 4
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults between 21 - 70 years.
- Patients undergoing tympanomastoid surgery.
- Both genders.
- ASA physical class I and II.
Who cannot join
- Patient refusal.
- Uncooperative patients.
- Allergy to the drug enrolled in the study.
- Anatomical abnormality at injection site.
- Infection at injection site.
- Bleeding disorders.
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- ASA physical class III and IV patients.
- Patients having significant chronic diseases as: uncontrolled asthma, cardiovascular disorders (significant arrhythmias, severe valvular diseases, congenital heart diseases, ischemic heart disease, or cardiomyopathy).
- Renal impairment (creatinine level ≥ 2mg/dl), or uncompensated chronic liver disease.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Cairo University
Cairo
Kareem MA Nawwar, M.D., +201003878369, drknawwar@cu.edu.eg
Kareem Nawwar, +201003878369, drknawwar@yahoo.com
About this study
Official title: The Efficacy of Bupivacaine 0.125% Versus Bupivacaine 0.25% in Superficial Cervical Plexus Block on Operative Field Visibility for Adults Undergoing Tympanomastoid Surgeries, A Prospective Randomized Controlled Study
Bleeding is one of the most common complications in tympanomastoid surgery that could prolong the time of operation and also might lead to morbidity. Pain is also one of the most annoying complications of tympanomastoid surgeries. Thus, adequate surgical field visualization is utmost important. A bloodless field allows optimal exposure and identification of vital neurovascular structures. Even small bleeding, inconsequential for the patient's volume status, can create great technical difficulty in the confined space of the tympan, leading to prolonged surgery, incomplete procedures, and increased complications.
The use of regional nerve blocks as an alternative to hypotensive anesthesia has gained popularity in recent years. The superficial cervical plexus block (SCPB) provides effective analgesia and reduces sympathetic activity, resulting in reduced bleeding and improved surgical conditions. The superficial cervical plexus (SCP) provides sensory innervation to the ear and surrounding structures, reducing pain perception during and after surgery.
Read more
This is the first randomized controlled clinical trial investigating the effect of combined general anesthesia with SCPB using 0.125% versus 0.25% bupivacaine during tympanomastoid surgery.
This study aims to compare the efficacy of two different concentrations of bupivacaine 0.125% \& 0.25% in Superficial Cervical Plexus Block in patients undergoing tympanomastoid surgery on operative field visualization, intraoperative hemodynamic stability, and postoperative analgesia.
The investigators hypothesize that bupivacaine 0.125% would be non-inferior to bupivacaine 0.25% in achieving optimal surgical field visualization, hemodynamic stability, surgeon satisfaction and postoperative analgesia.
This prospective double-blinded study will be carried out on 60 patients between 21 to 70 years, with ASA I-II and undergoing tympanomastoid surgery. Participants were equally divided into two groups: Group A: Patients received SCPB using 0.25% bupivacaine (5ml of bupivacaine 0.5% + 5ml normal saline). Group B: Patients received SCPB using 0.125% bupivacaine (2.5ml of bupivacaine 0.5% + 7.5ml normal saline).
- Conditions
- Surgical Field, Acute Postoperative Pain
- Being tested
- bupivacaine 0.25%, bupivacaine 0.125%
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupivacaine 0.25%Drug
superficial cervical plexus block using 10 ml of bupivacaine 0.25%
bupivacaine 0.125%Drug
superficial cervical plexus block using 10 ml of bupivacaine 0.125%
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine 0.25% | Active comparator | Patients will receive superficial cervical plexus block using 0.25% bupivacaine (5ml of bupivacaine 0.5% + 5ml normal saline). Receives: Drug: bupivacaine 0.25% |
| Bupivacaine 0.125% | Active comparator | Patients will receive superficial cervical plexus block using 0.125% bupivacaine (2.5ml of bupivacaine 0.5% + 7.5ml normal saline). Receives: Drug: bupivacaine 0.125% |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total consumption of IV glyceryl trinitrate
The total consumption of IV glyceryl trinitrate administered to maintain a surgical field with a Boezaart bleeding score ≤2 (grade 0 = no bleeding, grade 5 = severe bleeding threatening surgical field)
Measured: up to 5 hours
Secondary outcomes (3)
Fentanyl consumption
Total intraoperative consumption of fentanyl
Measured: up to 5 hours
Postoperative pain
Postoperative pain is measured by Visual Analog Scale (0 = no pain, 10 = worst imaginable pain)
Measured: 1 hour postoperatively
Postoperative hospital stay
Duration of postoperative hospital stay in days
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start1 May 2024
- Primary completion28 Jun 2024 (estimated)
- Study completion5 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical FieldStudies 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kareem Mohammed Assem Nawwar, Cairo University
- Investigators
- Nevan M Mekawy, M.D., Study chair, Professor of Anesthesiology, Surgical ICU & Pain Management, Cairo UniversityMohsen M Waheb, M.D., Study director, Lecturer of Anesthesiology, Surgical ICU & Pain Management, Cairo UniversityKareem MA Nawwar, M.D., Study director, Lecturer of Anesthesiology, Surgical ICU & Pain Management, Cairo UniversityFatma A Mohamed Hassan, M.B.B.Ch., Principal investigator, Resident of Anesthesia, Surgical ICU & Pain Management
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381401
- Sponsor's protocol ID
- MS-492-2023
- Status last verified
- May 2024
- First submitted
- 19 Apr 2024
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Bupivacaine 0.125% Versus Bupivacaine 0.25% in Superficial Cervical Plexus Block on Operative Field Visibility for Adults Undergoing Tympanomastoid Surgeries, A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06381401
- Acronym / sponsor ID
- MS-492-2023
- Conditions
- Surgical Field, Acute Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 28 Jun 2024 (estimated)
- Study completion
- 5 Jul 2024 (estimated)
- First posted
- 24 Apr 2024 (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.
Bleeding is one of the most common complications in tympanomastoid surgery that could prolong the time of operation and also might lead to morbidity. Pain is also one of the most annoying complications of tympanomastoid surgeries. Thus, adequate surgical field visualization is utmost important. A bloodless field allows optimal exposure and identification of vital neurovascular structures. Even small bleeding, inconsequential for the patient's volume status, can create great technical difficulty in the confined space of the tympan, leading to prolonged surgery, incomplete procedures, and increased complications.
The use of regional nerve blocks as an alternative to hypotensive anesthesia has gained popularity in recent years. The superficial cervical plexus block (SCPB) provides effective analgesia and reduces sympathetic activity, resulting in reduced bleeding and improved surgical conditions. The superficial cervical plexus (SCP) provides sensory innervation to the ear and surrounding structures, reducing pain perception during and after surgery.
This is the first randomized controlled clinical trial investigating the effect of combined general anesthesia with SCPB using 0.125% versus 0.25% bupivacaine during tympanomastoid surgery.
This study aims to compare the efficacy of two different concentrations of bupivacaine 0.125% \& 0.25% in Superficial Cervical Plexus Block in patients undergoing tympanomastoid surgery on operative field visualization, intraoperative hemodynamic stability, and postoperative analgesia.
The investigators hypothesize that bupivacaine 0.125% would be non-inferior to bupivacaine 0.25% in achieving optimal surgical field visualization, hemodynamic stability, surgeon satisfaction and postoperative analgesia.
This prospective double-blinded study will be carried out on 60 patients between 21 to 70 years, with ASA I-II and undergoing tympanomastoid surgery. Participants were equally divided into two groups: Group A: Patients received SCPB using 0.25% bupivacaine (5ml of bupivacaine 0.5% + 5ml normal saline). Group B: Patients received SCPB using 0.125% bupivacaine (2.5ml of bupivacaine 0.5% + 7.5ml normal saline).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine 0.25% | Active comparator | Drug: bupivacaine 0.25%Patients will receive superficial cervical plexus block using 0.25% bupivacaine (5ml of bupivacaine 0.5% + 5ml normal saline). |
| Bupivacaine 0.125% | Active comparator | Drug: bupivacaine 0.125%Patients will receive superficial cervical plexus block using 0.125% bupivacaine (2.5ml of bupivacaine 0.5% + 7.5ml normal saline). |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults between 21 - 70 years.
- Patients undergoing tympanomastoid surgery.
- Both genders.
- ASA physical class I and II.
Key exclusion criteria (9 listed)
- Patient refusal.
- Uncooperative patients.
- Allergy to the drug enrolled in the study.
- Anatomical abnormality at injection site.
- Infection at injection site.
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 |
|---|---|---|
| bupivacaine 0.25%superficial cervical plexus block using 10 ml of bupivacaine 0.25% | Drug | Bupivacaine 0.25% |
| bupivacaine 0.125%superficial cervical plexus block using 10 ml of bupivacaine 0.125% | Drug | Bupivacaine 0.125% |
Primary outcome
The total consumption of IV glyceryl trinitrate
Time frame: up to 5 hours
The total consumption of IV glyceryl trinitrate administered to maintain a surgical field with a Boezaart bleeding score ≤2 (grade 0 = no bleeding, grade 5 = severe bleeding threatening surgical field)
3 secondary outcomes
Fentanyl consumption
Time frame: up to 5 hours
Postoperative pain
Time frame: 1 hour postoperatively
Postoperative hospital stay
Time frame: 4 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
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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.
Nevan M Mekawy, M.D. study chair
Professor of Anesthesiology, Surgical ICU & Pain Management, Cairo University
Mohsen M Waheb, M.D. study director
Lecturer of Anesthesiology, Surgical ICU & Pain Management, Cairo University
Kareem MA Nawwar, M.D. study director
Lecturer of Anesthesiology, Surgical ICU & Pain Management, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bupivacaine 0.25% and bupivacaine 0.125% in people with Surgical Field and Acute Postoperative Pain, 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 4 inclusion and 9 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 7 May 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Kareem MA Nawwar, M.D. (+201003878369, drknawwar@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The total consumption of IV glyceryl trinitrate (time frame: up to 5 hours). 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 7 May 2024.