Skin Graft ComplicationsPhase 2NCT06766474
The Rule of Bupivacaine Hydrochloride in Skin Graft Donor Site
A Phase 2 study testing Bupivacain in people with Skin Graft Complications and Pain Management, run by Minia University at 1 site in Egypt.
Trial summary
Split Thickness Skin Graft is frequently utilized for reconstructing skin loss of various causes. Unfortunately, the donor site of the STSG has an unavoidable, annoying post-operative pain Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Skin Graft Complications, Pain Management
- What is being tested?
- Bupivacain
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 30 Oct 2024
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists Physical Status classification I-II
- scheduled for STSG harvested from a single thigh donor site to reconstruct skin loss post burn or trauma
Who cannot join
- uncooperative
- refusing patient,
- under immunosuppressive treatment
- diabetics
- lower-limb neuropathy
- under corticosteroids treatment
Show all 10Show fewer
- allergy to the study drug,
- STSG procedures performed under spinal anesthesia
- pregnancy
- had a history of opioid abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bupivacaine Hydrochloride-Soaked Dressing Versus Subcutaneous Infiltration for Postoperative Analgesia in Skin Graft Donor Site: a Randomized Controlled Clinical Trial
Split Thickness Skin Graft is frequently utilized for reconstructing skin loss of various causes. Unfortunately, the donor site of the STSG has an unavoidable, annoying post-operative pain
Read the detailed description
The primary objective of this study was to compare the efficacy of bupivacaine hydrochloride-soaked dressing versus bupivacaine HCL subcutaneous infiltration for postoperative donor site pain control for patients undergoing STSG procedures. The patients were divided in 3 equal groups, investigated soaked dressing vs subcutaneous infiltration vs conventional dressing .
- Conditions
- Skin Graft Complications, Pain Management
- Being tested
- Bupivacain
- Keywords
- bupivacaine, skin graft, pain, donor site, local anesthesia
- Medical subject headings
- Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacainDrug
to our knowledge, this study is the 1st to compare the efficacy of bupivacaine hydrochloride-soaked dressing versus subcutaneous infiltration for postoperative donor site pain control for patients undergoing STSG procedures.
| Study group | Role | What they receive |
|---|---|---|
| Group I (soaked dressing group) | Experimental | the donor site dressing was kept soaked in an aqueous solution of bupivacaine HCL in a concentration of 0.25%. Receives: Drug: Bupivacain |
| Group II (subcutaneous infiltration group) | Experimental | Subcutaneous infiltration of the study medication. Receives: Drug: Bupivacain |
| Group III (control group) | No intervention | the conventional dressing was applied without any adjectives |
What is being measured
The primary outcome is the main question the study is designed to answer.
screening pain
Numerical rating scale (NRS), 0, 1, 2, 4, 8, 12, 18 and 24h, a tool for screening pain, often utilized to evaluate pain intensity on a 0-10 scale, where zero indicates no pain and 10 signifies the worst pain possible, in the 1st 24h postoperatively
Measured: 24 hours
frequency of analgesia and the fentanyl requirement
1g of paracetamol IV was given to all patients every 8 h and if NRS >3 in the donor site patient received 30 mg IV of ketorolac (the frequency of analgesia), if the pain still, the patient was given fentanyl 50 mcg per time (fentanyl requirement) in the three studied groups Registration of the frequency of time of 1st analgesia, frequency of analgesia (ketorolac) and the fentanyl requirement over 1st 24 h as (0, 1, 2, 4, 8, 12, 18 and 24h).
Measured: 24 hours
Secondary outcomes (1)
side effects
recording any side effects such as convulsions and myocardial depression.
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 posted9 Jan 2025
- Study start1 Mar 2023
- Primary completion15 Oct 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Skin Graft ComplicationsStudies of the same condition, open and under way.
- More trials run by Minia 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MOHAMED SABRY, Minia University
- Investigators
- MOHAMED SABRY, MD, Principal investigator, Lecturer of plastic and reconstructive surgeryShadwa Rabea, MD, Principal investigator, Assistant professor of anesthesia and Intensive CareMohab Elsayed, Phd, Principal investigator, Assistant lecturer of plastic and reconstructive surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766474
- Sponsor's protocol ID
- bupivacaine analgesia
- Status last verified
- Jan 2025
- First submitted
- 4 Jan 2025
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shahzad F. Management of skin graft donor site in pediatric patients with tumescent technique and AQUACEL(R) Ag foam dressing. J Plast Surg Hand Surg. 2021 Oct;55(5):309-314. doi: 10.1080/2000656X.2021.1883632. Epub 2021 Feb 16.
PubMed 33591240Liu SS, Richman JM, Thirlby RC, Wu CL. Efficacy of continuous wound catheters delivering local anesthetic for postoperative analgesia: a quantitative and qualitative systematic review of randomized controlled trials. J Am Coll Surg. 2006 Dec;203(6):914-32. doi: 10.1016/j.jamcollsurg.2006.08.007. Epub 2006 Oct 25. No abstract available.
PubMed 17116561Sinha 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 28598907Bittner EA, Shank E, Woodson L, Martyn JA. Acute and perioperative care of the burn-injured patient. Anesthesiology. 2015 Feb;122(2):448-64. doi: 10.1097/ALN.0000000000000559.
PubMed 25485468Akan M, Yildirim S, Misirlioglu A, Ulusoy G, Akoz T, Avci G. An alternative method to minimize pain in the split-thickness skin graft donor site. Plast Reconstr Surg. 2003 Jun;111(7):2243-9. doi: 10.1097/01.PRS.0000060087.93322.2F.
PubMed 12794466
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bupivacaine Hydrochloride-Soaked Dressing Versus Subcutaneous Infiltration for Postoperative Analgesia in Skin Graft Donor Site: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06766474
- Acronym / sponsor ID
- bupivacaine analgesia
- Conditions
- Skin Graft Complications, Pain Management
- Keywords
- bupivacaine, skin graft, pain, donor site, local anesthesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 9 Jan 2025 (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 Graft is frequently utilized for reconstructing skin loss of various causes. Unfortunately, the donor site of the STSG has an unavoidable, annoying post-operative pain
Detailed description
The primary objective of this study was to compare the efficacy of bupivacaine hydrochloride-soaked dressing versus bupivacaine HCL subcutaneous infiltration for postoperative donor site pain control for patients undergoing STSG procedures. The patients were divided in 3 equal groups, investigated soaked dressing vs subcutaneous infiltration vs conventional dressing .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I (soaked dressing group) | Experimental | Drug: Bupivacainthe donor site dressing was kept soaked in an aqueous solution of bupivacaine HCL in a concentration of 0.25%. |
| Group II (subcutaneous infiltration group) | Experimental | Drug: BupivacainSubcutaneous infiltration of the study medication. |
| Group III (control group) | No intervention | –the conventional dressing was applied without any adjectives |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists Physical Status classification I-II
- scheduled for STSG harvested from a single thigh donor site to reconstruct skin loss post burn or trauma
Key exclusion criteria (10 listed)
- uncooperative
- refusing patient,
- under immunosuppressive treatment
- diabetics
- lower-limb neuropathy
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 |
|---|---|---|
| Bupivacainto our knowledge, this study is the 1st to compare the efficacy of bupivacaine hydrochloride-soaked dressing versus subcutaneous infiltration for postoperative donor site pain control for patients undergoing STSG procedures. | Drug | Group I (soaked dressing group), Group II (subcutaneous infiltration group) |
Primary outcome
screening pain
Time frame: 24 hours
Numerical rating scale (NRS), 0, 1, 2, 4, 8, 12, 18 and 24h, a tool for screening pain, often utilized to evaluate pain intensity on a 0-10 scale, where zero indicates no pain and 10 signifies the worst pain possible, in the 1st 24h postoperatively
frequency of analgesia and the fentanyl requirement
Time frame: 24 hours
1g of paracetamol IV was given to all patients every 8 h and if NRS >3 in the donor site patient received 30 mg IV of ketorolac (the frequency of analgesia), if the pain still, the patient was given fentanyl 50 mcg per time (fentanyl requirement) in the three studied groups Registration of the frequency of time of 1st analgesia, frequency of analgesia (ketorolac) and the fentanyl requirement over 1st 24 h as (0, 1, 2, 4, 8, 12, 18 and 24h).
1 secondary outcome
side effects
Time frame: 24 hours
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 13 Jan 2025.
- Background: PubMed 33591240Shahzad F. Management of skin graft donor site in pediatric patients with tumescent technique and AQUACEL(R) Ag foam dressing. J Plast Surg Hand Surg. 2021 Oct;55(5):309-314. doi: 10.1080/2000656X.2021.1883632. Epub 2021 Feb 16.
- Background: PubMed 17116561Liu SS, Richman JM, Thirlby RC, Wu CL. Efficacy of continuous wound catheters delivering local anesthetic for postoperative analgesia: a quantitative and qualitative systematic review of randomized controlled trials. J Am Coll Surg. 2006 Dec;203(6):914-32. doi: 10.1016/j.jamcollsurg.2006.08.007. Epub 2006 Oct 25. No abstract available.
- Background: 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.
- Background: PubMed 25485468Bittner EA, Shank E, Woodson L, Martyn JA. Acute and perioperative care of the burn-injured patient. Anesthesiology. 2015 Feb;122(2):448-64. doi: 10.1097/ALN.0000000000000559.
- Background: PubMed 12794466Akan M, Yildirim S, Misirlioglu A, Ulusoy G, Akoz T, Avci G. An alternative method to minimize pain in the split-thickness skin graft donor site. Plast Reconstr Surg. 2003 Jun;111(7):2243-9. doi: 10.1097/01.PRS.0000060087.93322.2F.
- Individual participant dataSharing planned: Undecided
Related trials for Skin Graft Complications
Recruiting
Lower Extremity Graft Study (LEGS): A Multicentre Randomised Controlled Trial of Negative Pressure Wound Therapy Versus Conventional Dressings for Split-thickness Skin Grafts After Lower Leg Skin Tumour Excision
Skin Transplantation, Skin Grafting
RecruitingPhase 4
Burn Study- Tranexamic Acid Versus Thrombin in Split Thickness Skin Graft
Burns, Skin Graft Complications
Recruiting
Aloe Vera vs Paraffin Tulle Dressings for Pain Management in Split Thickness Skin Graft Donor Sites
Skin Graft Wounds, Donor Site Complication
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.
MOHAMED SABRY, MD principal investigator
Lecturer of plastic and reconstructive surgery
Shadwa Rabea, MD principal investigator
Assistant professor of anesthesia and Intensive Care
Mohab Elsayed, Phd principal investigator
Assistant lecturer of plastic and reconstructive surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bupivacain in people with Skin Graft Complications and Pain Management, run by Minia 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 2 inclusion and 10 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 13 Jan 2025. 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 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?
screening pain (time frame: 24 hours). The study lists 2 primary outcomes in all. 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 NCT06766474, which also lists 5 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 13 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.