Intraoperative BleedingPhase 2NCT03047070
Lidocaine in ERAS for FESS
A Phase 2 study testing Lidocaine and Normal saline in people with Intraoperative Bleeding, run by Assiut University at 2 sites in Egypt.
Trial summary
Functional endoscopic sinus surgery (FESS) is a commonly performed procedure. It is known that bleeding during FESS can affect directly to the visibility of safe landmarks and surgical outcomes. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Intraoperative Bleeding
- What is being tested?
- Lidocaine and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 2 sitesEgypt
- Study dates
- 9 Feb 2017to 31 Dec 2021
- Phase
- Phase 2
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients, 20-50 yr ASA class I and II
- Elective Functional endoscopic sinus surgery (FESS) under general anesthesia.
Who cannot join
- Patient refusal, allergy to the study medication, pre-existing chronic pain at any site requiring treatment, intolerance to nonsteroidal anti-inflammatory drugs (NSAIDs), psychiatric or neurological disorders, seizure disorder requiring medication within the previous 2 years, body mass index > 30 kg/ m2, revision sinus surgery, pregnancy, and patients with cardiovascular, cerebrovascular, respiratory, renal or hepatic diseases
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of Medicine Assuit University
Asyut, Assuit, 71111
Seham Mohamed Moeen Ibrahim
Asyut, 71111
About this study
Official title: Lidocaine Infusion in Functional Endoscopic Sinus Surgery
Functional endoscopic sinus surgery (FESS) is a commonly performed procedure. It is known that bleeding during FESS can affect directly to the visibility of safe landmarks and surgical outcomes.
Read the detailed description
Functional endoscopic sinus surgery (FESS) is a commonly performed procedure in the head and neck field. It is known that bleeding during FESS can affect directly to the visibility of safe landmarks and surgical outcomes.
Use of vasoactive drugs to control bleeding is not without pitfalls. Systemic effects of epinephrine may constitute a potential hazard in patients with hypertension, ischemic heart disease, anemia, preexistent liver or renal damage and endocrine dysfunction (hyperthyroidism, pheochromocytoma and diabetes mellitus).
Lidocaine is a prototypical local anesthetic, but it also has systemic effects that are mediated by inhibitory effects on N-methyl-d-aspartate receptors and leukocyte priming. Consequently, systemic lidocaine is antiinflammatory, analgesic, and antihyperalgesic. Randomized clinical trials, however, have produced mixed results. Several studies have shown reduction in postoperative opioid consumption and pain scores, whereas others have failed to show a benefit.
- Conditions
- Intraoperative Bleeding
- Being tested
- Lidocaine, Normal saline
- Medical subject headings
- Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
IV Lidocaine infusion
Normal salineDrug
IV normal saline infusion
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Active comparator | IV Lidocaine infusion Receives: Drug: Lidocaine |
| Control | Placebo comparator | IV normal saline infusion Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative bleeding
Will be calculated from the fluid volume of the suction canister. The volume of irrigating fluid will subtracted from the total volume of fluid contained in the suction bottle. Additionally, a fully soaked cotton strip will be assumed to contain 5 ml of blood and a partially soaked one to contain 2-3 ml of blood
Measured: Intraoperative assessment till end of operation
Secondary outcomes (4)
Quality of surgical field
The surgeon will assess the quality of surgical field every 15 min after the beginning of drug infusion for the first 60 min according to a 6-point Boezaart scale
Measured: intraoperative assessment
Surgeon satisfaction
with a 4-point scale: 1 = Poor, 2 = Moderate, 3 = Good, 4 = Excellent
Measured: At the end of surgery
Mean arterial pressure
Will be assessed at the initial phase (baseline), immediately after induction of anesthesia, and then 15, 30. 45, 60 min after the begining of drug infusion
Measured: intraoperative assessment
Heart rate
Will be assessed at the initial phase (baseline), immediately after induction of anesthesia, and then 15, 30. 45, 60 min after the begining of drug infusion
Measured: intraoperative assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start9 Feb 2017
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative BleedingStudies of the same condition, open and under way.
- More trials run by Assiut 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seham Mohamed Moeen Ibrahim, Assiut University
- Investigators
- Seham M Moeen, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047070
- Sponsor's protocol ID
- SM22017
- Status last verified
- Apr 2022
- First submitted
- 6 Feb 2017
- Last updated
- 28 Apr 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 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lidocaine Infusion in Functional Endoscopic Sinus Surgery
- ClinicalTrials.gov ID
- NCT03047070
- Acronym / sponsor ID
- SM22017
- Conditions
- Intraoperative Bleeding
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 9 Feb 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 8 Feb 2017 (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.
Functional endoscopic sinus surgery (FESS) is a commonly performed procedure. It is known that bleeding during FESS can affect directly to the visibility of safe landmarks and surgical outcomes.
Detailed description
Functional endoscopic sinus surgery (FESS) is a commonly performed procedure in the head and neck field. It is known that bleeding during FESS can affect directly to the visibility of safe landmarks and surgical outcomes.
Use of vasoactive drugs to control bleeding is not without pitfalls. Systemic effects of epinephrine may constitute a potential hazard in patients with hypertension, ischemic heart disease, anemia, preexistent liver or renal damage and endocrine dysfunction (hyperthyroidism, pheochromocytoma and diabetes mellitus).
Lidocaine is a prototypical local anesthetic, but it also has systemic effects that are mediated by inhibitory effects on N-methyl-d-aspartate receptors and leukocyte priming. Consequently, systemic lidocaine is antiinflammatory, analgesic, and antihyperalgesic. Randomized clinical trials, however, have produced mixed results. Several studies have shown reduction in postoperative opioid consumption and pain scores, whereas others have failed to show a benefit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Active comparator | Drug: LidocaineIV Lidocaine infusion |
| Control | Placebo comparator | Drug: Normal salineIV normal saline infusion |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients, 20-50 yr ASA class I and II
- Elective Functional endoscopic sinus surgery (FESS) under general anesthesia.
Key exclusion criteria (1 listed)
- Patient refusal, allergy to the study medication, pre-existing chronic pain at any site requiring treatment, intolerance to nonsteroidal anti-inflammatory drugs (NSAIDs), psychiatric or neurological disorders, seizure disorder requiring medication within the previous 2 years, body mass index > 30 kg/ m2, revision sinus surgery, pregnancy, and patients with cardiovascular, cerebrovascular, respiratory, renal or hepatic diseases
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 |
|---|---|---|
| LidocaineIV Lidocaine infusion | Drug | Lidocaine |
| Normal salineIV normal saline infusion | Drug | Control |
Primary outcome
Intraoperative bleeding
Time frame: Intraoperative assessment till end of operation
Will be calculated from the fluid volume of the suction canister. The volume of irrigating fluid will subtracted from the total volume of fluid contained in the suction bottle. Additionally, a fully soaked cotton strip will be assumed to contain 5 ml of blood and a partially soaked one to contain 2-3 ml of blood
4 secondary outcomes
Quality of surgical field
Time frame: intraoperative assessment
Surgeon satisfaction
Time frame: At the end of surgery
Mean arterial pressure
Time frame: intraoperative assessment
Heart rate
Time frame: intraoperative assessment
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 28 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Seham M Moeen, MD principal investigator
Assiut University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lidocaine and Normal saline in people with Intraoperative Bleeding, run by Assiut University at 2 sites 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 2 inclusion and 1 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 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Intraoperative bleeding (time frame: Intraoperative assessment till end 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 28 Apr 2022.