Post Operative PainNCT05817474
Efficacy of Local Infiltration of Tranexamic Acid and Lidocaine in Tonsillar Bed on Postoperative Bleeding and Pain During Tonsillectomy Surgery: Prospective, Randomized, Control Study
A study testing lidocaine (2 %) 2 ml and tranexamic acid in people with Post Operative Pain and Postoperative Hemorrhage, run by mohamed at 1 site in Egypt.
Trial summary
All anesthetic techniques aim to lessen intra-operative surgical site bleeding because it is a major problem and does not help with precision, surgery time, or postoperative wound healing. The main reason for reoperation and mortality in children who have had tonsillectomies is post-tonsillectomy hemorrhage. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Post Operative Pain, Postoperative Hemorrhage
- What is being tested?
- lidocaine (2 %) 2 ml and tranexamic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to 1 Mar 2023
- 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female child between 4 and 12 years old
- ASA one and two, planned for an elective tonsillectomy
- Patients having 4 or more episodes of tonsillitis in the last year, 5 or more episodes in the previous two years, or 7 episodes in the previous three years.
Who cannot join
- 1-Children with diabetes mellitus, problems of the heart, kidneys, or liver 4-Obstructive sleep apnea syndrome 5-blood disorders, or a propensity to hemorrhage 6-patients suspected of an allergy to the drug being administered, and those undergoing concurrent surgery such as an adenoidectomy or tongue tie.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Local Infiltration of Tranexamic Acid and Lidocaine in Tonsillar Bed on Postoperative Bleeding and Pain During Tonsillectomy Surgery.
All anesthetic techniques aim to lessen intra-operative surgical site bleeding because it is a major problem and does not help with precision, surgery time, or postoperative wound healing. The main reason for reoperation and mortality in children who have had tonsillectomies is post-tonsillectomy hemorrhage. Pre-emptive analgesia reduces surgical pain blocking of central sensitization by topical or systemic medications.
Read the detailed description
The control of postoperative pain in children after tonsillectomy is a crucial issue. After a tonsillectomy, it is crucial to receive enough postoperative analgesia since discomfort limits swallowing, increases the risk of dehydration, infection, and subsequent bleeding, and can impede a quick recovery and painless convalescence. Immediately following surgery and during the first 24th hours, this pain is at its most intense (1).
The main reason for reoperation and mortality in children who have had tonsillectomy is post-tonsillectomy hemorrhage (PTH). These two categories of PTH as primary bleeding in the first 24 hours and secondary bleeding (after 24th hours). Most PTH cases are secondary, with incidence reaching its peak between days 5 and 7 after surgery when the fibrin clot breaks from the tonsillar fossa. PTH requiring surgical intervention will be an emergency that most anesthesiologists will encounter in their clinical practice (2).
In numerous surgical procedures, bleeding has been observed to be reduced by antifibrinolytic transexamic acid (3). It has been demonstrated that transexamic acid can reduce blood loss during tonsillectomy but has no impact on whether PTH develops in tonsillectomy patients. When administered by nebulization in the emergency room to a patient who was 3 years old, tranexamic acid has been found to reduce secondary PTH (4).
Plasminogen activation is competitively inhibited by tranexamic acid. As a result of inhibition of the fibrinolysis, it prevents the clots from being broken down thereby significantly reducing surgical hemorrhage. After surgical stress, fibrinolysis occurs more frequently, especially in complex surgeries like total knee arthroplasty. Fibrinolysis reaches its peak six hours after surgery and continues to occur at a high rate for up to 18 hours. When administered during this time, tranexamic acid can significantly less blood loss (5). In those who are predisposed, thrombosis risk from tranexamic acid exists. Orthostatic difficulties, vision abnormalities, headaches, myoclonus, and rash are among other uncommon adverse effects.
The safety and efficacy of tranexamic acid (TXA) have been well studied by surgical services including cardiac, orthopedic, dental, trauma, critical care, and dermatologic surgery. However, except for craniofacial surgery (6). The most serious problems following a tonsillectomy include hemorrhage and respiratory obstruction from edema. The most frequent complaint in the initial post-operative phase is pain. With individual differences, the pain increases anxiety and the fear of swallowing, predisposes to delayed food intake, reduces respiratory effort, increases the risk of pulmonary problems, and lengthens hospital stays (7).
Pre-emptive analgesia, which reduces surgical pain, is the blocking of central sensitization by topical or systemic medications. Opioids, steroids, and NSAIDs have all been tested as pre-emptive analgesics, as well as local anesthetic sprays and infiltration in the tonsillar fossa (8). The use of local anesthetics, opioids, ketamine (9), gabapentin (10), corticosteroids, and even non-pharmacologic interventions as adjuvant local analgesic compounds has been cited frequently in recent years in children undergoing adenotonsillectomy (11).
- Conditions
- Post Operative Pain, Postoperative Hemorrhage
- Being tested
- lidocaine (2 %) 2 ml and tranexamic acid
- Keywords
- Tonsillectomy, Lidocaine
- Medical subject headings
- Pain, Postoperative, Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaine (2 %) 2 ml and tranexamic acidDrug
lidocaine (2 %) 2 ml and tranexamic acid 2 ml in each tonsillar bed
| Study group | Role | What they receive |
|---|---|---|
| Group T | Experimental | Group T: received lidocaine (2 %) 2 ml and tranexamic acid 2 ml in each tonsillar bed; Receives: Drug: lidocaine (2 %) 2 ml and tranexamic acid |
| Group N | Placebo comparator | Group N (Control group): received 4 ml of normal saline in each tonsillar bed. Receives: Drug: lidocaine (2 %) 2 ml and tranexamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative bleeding, pain and postoperative opioid consumption
Postoperative bleeding, pain and postoperative opioid consumption
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 May 2022
- Primary completion15 May 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- mohamed
- Sponsor type
- University, hospital or other
- Collaborators
- Al-Azhar University
- Responsible party
- Sponsor-investigator, mohamed, Al-Azhar University
- Investigators
- abdalla mohamed abdalla, MD, Principal investigator, AZHAR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817474
- Sponsor's protocol ID
- Mohamed
- Status last verified
- Apr 2023
- First submitted
- 5 Apr 2023
- Last updated
- 21 Apr 2023
- Results posted
- No
- 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 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Local Infiltration of Tranexamic Acid and Lidocaine in Tonsillar Bed on Postoperative Bleeding and Pain During Tonsillectomy Surgery.
- ClinicalTrials.gov ID
- NCT05817474
- Acronym / sponsor ID
- Mohamed
- Conditions
- Post Operative Pain, Postoperative Hemorrhage
- Keywords
- Tonsillectomy, Lidocaine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- mohamedUniversity, hospital or other
- Collaborators
- Al-Azhar University
- Study start
- 1 May 2022 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 18 Apr 2023 (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.
All anesthetic techniques aim to lessen intra-operative surgical site bleeding because it is a major problem and does not help with precision, surgery time, or postoperative wound healing. The main reason for reoperation and mortality in children who have had tonsillectomies is post-tonsillectomy hemorrhage. Pre-emptive analgesia reduces surgical pain blocking of central sensitization by topical or systemic medications.
Detailed description
The control of postoperative pain in children after tonsillectomy is a crucial issue. After a tonsillectomy, it is crucial to receive enough postoperative analgesia since discomfort limits swallowing, increases the risk of dehydration, infection, and subsequent bleeding, and can impede a quick recovery and painless convalescence. Immediately following surgery and during the first 24th hours, this pain is at its most intense (1).
The main reason for reoperation and mortality in children who have had tonsillectomy is post-tonsillectomy hemorrhage (PTH). These two categories of PTH as primary bleeding in the first 24 hours and secondary bleeding (after 24th hours). Most PTH cases are secondary, with incidence reaching its peak between days 5 and 7 after surgery when the fibrin clot breaks from the tonsillar fossa. PTH requiring surgical intervention will be an emergency that most anesthesiologists will encounter in their clinical practice (2).
In numerous surgical procedures, bleeding has been observed to be reduced by antifibrinolytic transexamic acid (3). It has been demonstrated that transexamic acid can reduce blood loss during tonsillectomy but has no impact on whether PTH develops in tonsillectomy patients. When administered by nebulization in the emergency room to a patient who was 3 years old, tranexamic acid has been found to reduce secondary PTH (4).
Plasminogen activation is competitively inhibited by tranexamic acid. As a result of inhibition of the fibrinolysis, it prevents the clots from being broken down thereby significantly reducing surgical hemorrhage. After surgical stress, fibrinolysis occurs more frequently, especially in complex surgeries like total knee arthroplasty. Fibrinolysis reaches its peak six hours after surgery and continues to occur at a high rate for up to 18 hours. When administered during this time, tranexamic acid can significantly less blood loss (5). In those who are predisposed, thrombosis risk from tranexamic acid exists. Orthostatic difficulties, vision abnormalities, headaches, myoclonus, and rash are among other uncommon adverse effects.
The safety and efficacy of tranexamic acid (TXA) have been well studied by surgical services including cardiac, orthopedic, dental, trauma, critical care, and dermatologic surgery. However, except for craniofacial surgery (6). The most serious problems following a tonsillectomy include hemorrhage and respiratory obstruction from edema. The most frequent complaint in the initial post-operative phase is pain. With individual differences, the pain increases anxiety and the fear of swallowing, predisposes to delayed food intake, reduces respiratory effort, increases the risk of pulmonary problems, and lengthens hospital stays (7).
Pre-emptive analgesia, which reduces surgical pain, is the blocking of central sensitization by topical or systemic medications. Opioids, steroids, and NSAIDs have all been tested as pre-emptive analgesics, as well as local anesthetic sprays and infiltration in the tonsillar fossa (8). The use of local anesthetics, opioids, ketamine (9), gabapentin (10), corticosteroids, and even non-pharmacologic interventions as adjuvant local analgesic compounds has been cited frequently in recent years in children undergoing adenotonsillectomy (11).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group T | Experimental | Drug: lidocaine (2 %) 2 ml and tranexamic acidGroup T: received lidocaine (2 %) 2 ml and tranexamic acid 2 ml in each tonsillar bed; |
| Group N | Placebo comparator | Drug: lidocaine (2 %) 2 ml and tranexamic acidGroup N (Control group): received 4 ml of normal saline in each tonsillar bed. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Male or female child between 4 and 12 years old
- ASA one and two, planned for an elective tonsillectomy
- Patients having 4 or more episodes of tonsillitis in the last year, 5 or more episodes in the previous two years, or 7 episodes in the previous three years.
Key exclusion criteria (1 listed)
- 1-Children with diabetes mellitus, problems of the heart, kidneys, or liver 4-Obstructive sleep apnea syndrome 5-blood disorders, or a propensity to hemorrhage 6-patients suspected of an allergy to the drug being administered, and those undergoing concurrent surgery such as an adenoidectomy or tongue tie.
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 |
|---|---|---|
| lidocaine (2 %) 2 ml and tranexamic acidlidocaine (2 %) 2 ml and tranexamic acid 2 ml in each tonsillar bed | Drug | Group N, Group T |
Primary outcome
Postoperative bleeding, pain and postoperative opioid consumption
Time frame: 12 month
Postoperative bleeding, pain and postoperative opioid consumption
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 21 Apr 2023.
- 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.
abdalla mohamed abdalla, MD principal investigator
AZHAR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lidocaine (2 %) 2 ml and tranexamic acid in people with Post Operative Pain and Postoperative Hemorrhage, run by mohamed 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 3 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 21 Apr 2023. 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?
Postoperative bleeding, pain and postoperative opioid consumption (time frame: 12 month). 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 21 Apr 2023.