Postoperative PainPhase 4InterventionalNCT04561856
Fascia Iliaca Block Supplemented With Perineural Vs Intravenous Dexamethasone
A Phase 4 study testing Dexamethasone in people with Postoperative Pain, run by Assiut University.
Trial summary
Split-thickness skin grafting is the current standard of care for the reconstructive procedures in managing burn injuries and traumatic tissue defects. Harvesting split-thickness skin creates a new partial thickness wound that is referred to as the donor site . Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2020to 20 Apr 2022
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA I - II
- Scheduled for split thickness grafting.
- Availability and suitability of lateral and anterior aspects of the thigh as a donor site.
Who cannot join
- Patient's guardian refusal to participate in the study.
- Known allergy to local anesthetics
- Children known to be diabetic.
- Coagulopathy.
- Children with motor or sensory deficits in lower extremities.
- Children who are morbidly obese (BMI≥35) because ultrasound guided regional anesthesia could be technically difficult.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Fascia Iliaca Block Supplemented With Perineural Vs Intravenous Dexamethasone: Effect On Post-Operative Pain In Children Undergoing Split Thickness Skin Grafting.
Split-thickness skin grafting is the current standard of care for the reconstructive procedures in managing burn injuries and traumatic tissue defects. Harvesting split-thickness skin creates a new partial thickness wound that is referred to as the donor site . Donor site pain is one of the most distressing symptoms reported by patients in the early postoperative period. Larger donor sites stimulate a greater number of pain receptors and consequently pain is proportional to the size of the graft harvested.Often, the donor site is reported to be more painful than the recipient site,affecting early mobilization, sleep, and need for analgesics postoperatively.
Read the detailed description
Most commonly split thickness auto-grafts are harvested from a convenient and minimally aesthetically intrusive site; often the lateral thigh area, which is innervated by lateral femoral cutaneous nerve (LFCN). However if a larger graft area in needed then it will be obtained from the anterior aspect of the thigh, which is innervated by the femoral nerve.
Regional nerve blockade has been proposed for skin graft harvest and proofed to provide better and longer standing analgesia. Application of fascia iliaca compartment block involves the distribution of anesthesia to the territories of the femoral and lateral cutaneous nerves.
American society of regional anesthesia and pain medicine recommendations on local anesthetics in pediatric regional anesthesia in 2018 stated that the ultrasound guided fascial plane blocks as fascia iliaca block can be successfully and safely performed using a recommended dose of 0.25-0.75 mg/kg of bupivacaine 0.25%.
Prolongation of analgesia after surgery under regional anaesthesia is a goal for clinicians. Many investigators have sought that the ideal analgesic adjuvant that would both prolongs pain relief and avoids side effects after a single-shot peripheral nerve block. Although many agents have failed this test (opioids, ketamine, clonidine, etc.), the perineural addition of dexamethasone to local anaesthetic has been shown in several studies to prolong the analgesic effect and its use has become common in clinical practice around the world. Not surprisingly, much research has been performed with the aim of providing Level 1 evidence via randomized controlled trials design and systematic review and meta-analysis. Despite this, there is still no adequate answer as to whether perineural dexamethasone is superior to systemic administration alone.
- Conditions
- Postoperative Pain
- Being tested
- Dexamethasone, Placebo
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Intravenous 4mg
DexamethasoneDrug
Perineural 4mg
PlaceboDrug
Normal Saline 2ml
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Active comparator | will include 33 patients: each one will receive US guided fascia-iliaca block with 0.7 ml/kg of bupivacaine 0.25% plus 2 ml of normal saline perinural plus 0.15 mg/kg dexamethasone (maximum of 4 mg) in 2 ml volume intravenously. Receives: Drug: Dexamethasone |
| Group2 | Active comparator | will include 33 patients: each one will receive US guided fascia-iliaca block with 0.7 ml/kg of bupivacaine 0.25% plus 0.15 mg/kg dexamethasone (maximum of 4 mg) in 2 ml volume perinural plus 2 ml of normal saline intravenously. Receives: Drug: Dexamethasone |
| Group3 | Placebo comparator | will include 33 patients: each one will receive US guided fascia-iliaca block with 0.7 ml/kg of bupivacaine 0.25% plus 2 ml of normal saline perinural plus 2 ml of normal saline intravenously. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of first postoperative analgesia requirement using FLACC score
FLACC Score for the first 24 hours postoperative; 0 = Relaxed and comfortable, 1-3 = Mild discomfort, 4-6 = Moderate pain, 7-10 = Severe discomfort/pain or both.And The total consumption of postoperative rescue analgesics (total of paracetamol doses) will be recorded over 24 hours.
Measured: 24 Hours
Secondary outcomes (2)
Intraoperative blood pressure
Intraoperative blood pressure will be recorded every 3 minutes till the end of the procedure then postoperative at 1,2, 4,8,12,16 and 24 hours.
Measured: 24 Hours
Intraoperative heart rate
Intraoperative heart rate will be recorded every 3 minutes till the end of the procedure then postoperative at 1,2, 4,8,12,16 and 24 hours.
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start30 Sep 2020 (estimated)
- Primary completion30 Sep 2021 (estimated)
- Study completion20 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Mahmoud Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561856
- Sponsor's protocol ID
- FIBS
- Acronym
- Interventional
- Status last verified
- Sep 2020
- First submitted
- 20 Sep 2020
- Last updated
- 24 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sinha S, Schreiner AJ, Biernaskie J, Nickerson D, Gabriel VA. Treating pain on skin graft donor sites: Review and clinical recommendations. J Trauma Acute Care Surg. 2017 Nov;83(5):954-964. doi: 10.1097/TA.0000000000001615.
PubMed 28598907Shank ES, Martyn JA, Donelan MB, Perrone A, Firth PG, Driscoll DN. Ultrasound-Guided Regional Anesthesia for Pediatric Burn Reconstructive Surgery: A Prospective Study. J Burn Care Res. 2016 May-Jun;37(3):e213-7. doi: 10.1097/BCR.0000000000000174.
PubMed 25412051Shteynberg A, Riina LH, Glickman LT, Meringolo JN, Simpson RL. Ultrasound guided lateral femoral cutaneous nerve (LFCN) block: safe and simple anesthesia for harvesting skin grafts. Burns. 2013 Feb;39(1):146-9. doi: 10.1016/j.burns.2012.02.015. Epub 2012 May 30.
PubMed 22657583Suresh S, Ecoffey C, Bosenberg A, Lonnqvist PA, de Oliveira GS Jr, de Leon Casasola O, de Andres J, Ivani G. The European Society of Regional Anaesthesia and Pain Therapy/American Society of Regional Anesthesia and Pain Medicine Recommendations on Local Anesthetics and Adjuvants Dosage in Pediatric Regional Anesthesia. Reg Anesth Pain Med. 2018 Feb;43(2):211-216. doi: 10.1097/AAP.0000000000000702.
PubMed 29319604Hewson D, Bedforth N, McCartney C, Hardman J. Dexamethasone and peripheral nerve blocks: back to basic (science). Br J Anaesth. 2019 Apr;122(4):411-412. doi: 10.1016/j.bja.2019.02.004. Epub 2019 Feb 25. No abstract available.
PubMed 30857596Veneziano G, Martin DP, Beltran R, Barry N, Tumin D, Burrier C, Klingele K, Bhalla T, Tobias JD. Dexamethasone as an Adjuvant to Femoral Nerve Block in Children and Adolescents Undergoing Knee Arthroscopy: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial. Reg Anesth Pain Med. 2018 May;43(4):438-444. doi: 10.1097/AAP.0000000000000739.
PubMed 29377866
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fascia Iliaca Block Supplemented With Perineural Vs Intravenous Dexamethasone: Effect On Post-Operative Pain In Children Undergoing Split Thickness Skin Grafting.
- ClinicalTrials.gov ID
- NCT04561856
- Acronym / sponsor ID
- Interventional / FIBS
- Conditions
- Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Sep 2020 (estimated)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 20 Apr 2022 (estimated)
- First posted
- 24 Sep 2020 (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.
Split-thickness skin grafting is the current standard of care for the reconstructive procedures in managing burn injuries and traumatic tissue defects. Harvesting split-thickness skin creates a new partial thickness wound that is referred to as the donor site . Donor site pain is one of the most distressing symptoms reported by patients in the early postoperative period. Larger donor sites stimulate a greater number of pain receptors and consequently pain is proportional to the size of the graft harvested.Often, the donor site is reported to be more painful than the recipient site,affecting early mobilization, sleep, and need for analgesics postoperatively.
Detailed description
Most commonly split thickness auto-grafts are harvested from a convenient and minimally aesthetically intrusive site; often the lateral thigh area, which is innervated by lateral femoral cutaneous nerve (LFCN). However if a larger graft area in needed then it will be obtained from the anterior aspect of the thigh, which is innervated by the femoral nerve.
Regional nerve blockade has been proposed for skin graft harvest and proofed to provide better and longer standing analgesia. Application of fascia iliaca compartment block involves the distribution of anesthesia to the territories of the femoral and lateral cutaneous nerves.
American society of regional anesthesia and pain medicine recommendations on local anesthetics in pediatric regional anesthesia in 2018 stated that the ultrasound guided fascial plane blocks as fascia iliaca block can be successfully and safely performed using a recommended dose of 0.25-0.75 mg/kg of bupivacaine 0.25%.
Prolongation of analgesia after surgery under regional anaesthesia is a goal for clinicians. Many investigators have sought that the ideal analgesic adjuvant that would both prolongs pain relief and avoids side effects after a single-shot peripheral nerve block. Although many agents have failed this test (opioids, ketamine, clonidine, etc.), the perineural addition of dexamethasone to local anaesthetic has been shown in several studies to prolong the analgesic effect and its use has become common in clinical practice around the world. Not surprisingly, much research has been performed with the aim of providing Level 1 evidence via randomized controlled trials design and systematic review and meta-analysis. Despite this, there is still no adequate answer as to whether perineural dexamethasone is superior to systemic administration alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group1 | Active comparator | Drug: Dexamethasonewill include 33 patients: each one will receive US guided fascia-iliaca block with 0.7 ml/kg of bupivacaine 0.25% plus 2 ml of normal saline perinural plus 0.15 mg/kg dexamethasone (maximum of 4 mg) in 2 ml volume intravenously. |
| Group2 | Active comparator | Drug: Dexamethasonewill include 33 patients: each one will receive US guided fascia-iliaca block with 0.7 ml/kg of bupivacaine 0.25% plus 0.15 mg/kg dexamethasone (maximum of 4 mg) in 2 ml volume perinural plus 2 ml of normal saline intravenously. |
| Group3 | Placebo comparator | Drug: Placebowill include 33 patients: each one will receive US guided fascia-iliaca block with 0.7 ml/kg of bupivacaine 0.25% plus 2 ml of normal saline perinural plus 2 ml of normal saline intravenously. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA I - II
- Scheduled for split thickness grafting.
- Availability and suitability of lateral and anterior aspects of the thigh as a donor site.
Key exclusion criteria (6 listed)
- Patient's guardian refusal to participate in the study.
- Known allergy to local anesthetics
- Children known to be diabetic.
- Coagulopathy.
- Children with motor or sensory deficits in lower extremities.
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 |
|---|---|---|
| DexamethasoneIntravenous 4mg | Drug | Group1 |
| DexamethasonePerineural 4mg | Drug | Group2 |
| PlaceboNormal Saline 2ml | Drug | Group3 |
Primary outcome
Time of first postoperative analgesia requirement using FLACC score
Time frame: 24 Hours
FLACC Score for the first 24 hours postoperative; 0 = Relaxed and comfortable, 1-3 = Mild discomfort, 4-6 = Moderate pain, 7-10 = Severe discomfort/pain or both.And The total consumption of postoperative rescue analgesics (total of paracetamol doses) will be recorded over 24 hours.
2 secondary outcomes
Intraoperative blood pressure
Time frame: 24 Hours
Intraoperative heart rate
Time frame: 24 Hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
- Results publication: PubMed 28598907Sinha S, Schreiner AJ, Biernaskie J, Nickerson D, Gabriel VA. Treating pain on skin graft donor sites: Review and clinical recommendations. J Trauma Acute Care Surg. 2017 Nov;83(5):954-964. doi: 10.1097/TA.0000000000001615.
- Results publication: PubMed 25412051Shank ES, Martyn JA, Donelan MB, Perrone A, Firth PG, Driscoll DN. Ultrasound-Guided Regional Anesthesia for Pediatric Burn Reconstructive Surgery: A Prospective Study. J Burn Care Res. 2016 May-Jun;37(3):e213-7. doi: 10.1097/BCR.0000000000000174.
- Results publication: PubMed 22657583Shteynberg A, Riina LH, Glickman LT, Meringolo JN, Simpson RL. Ultrasound guided lateral femoral cutaneous nerve (LFCN) block: safe and simple anesthesia for harvesting skin grafts. Burns. 2013 Feb;39(1):146-9. doi: 10.1016/j.burns.2012.02.015. Epub 2012 May 30.
- Results publication: PubMed 29319604Suresh S, Ecoffey C, Bosenberg A, Lonnqvist PA, de Oliveira GS Jr, de Leon Casasola O, de Andres J, Ivani G. The European Society of Regional Anaesthesia and Pain Therapy/American Society of Regional Anesthesia and Pain Medicine Recommendations on Local Anesthetics and Adjuvants Dosage in Pediatric Regional Anesthesia. Reg Anesth Pain Med. 2018 Feb;43(2):211-216. doi: 10.1097/AAP.0000000000000702.
- Results publication: PubMed 30857596Hewson D, Bedforth N, McCartney C, Hardman J. Dexamethasone and peripheral nerve blocks: back to basic (science). Br J Anaesth. 2019 Apr;122(4):411-412. doi: 10.1016/j.bja.2019.02.004. Epub 2019 Feb 25. No abstract available.
- Results publication: PubMed 29377866Veneziano G, Martin DP, Beltran R, Barry N, Tumin D, Burrier C, Klingele K, Bhalla T, Tobias JD. Dexamethasone as an Adjuvant to Femoral Nerve Block in Children and Adolescents Undergoing Knee Arthroscopy: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial. Reg Anesth Pain Med. 2018 May;43(4):438-444. doi: 10.1097/AAP.0000000000000739.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone in people with Postoperative Pain, run by Assiut 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 3 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: status not confirmed, as of the sponsor's last update on 24 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. 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 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 Hany Ahmed Ibrahim El morabaa, Professor (01005203980, hany.ibrahim@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of first postoperative analgesia requirement using FLACC score (time frame: 24 Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04561856, which also lists 6 linked publications.
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 24 Sep 2020.