PerineuralNCT05830630
Perineural Methylene Blue Infusion in Lower Limb Amputation Surgery
A study testing Bupivacaine methylene blue and bupivacaine saline in people with Perineural and Methylene Blue, run by Tanta University at 1 site in Egypt.
Trial summary
This prospective randomized controlled study will be conducted to evaluate the analgesic effect of continuous perineural infusion of methylene blue with bupivacaine on acute postoperative pain and to evaluate its preventive role against chronic phantom pain in patients undergoing lower limb amputation surgery Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Perineural, Methylene Blue, Lower Limb Amputation
- What is being tested?
- Bupivacaine methylene blue and bupivacaine saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients of both genders, suffering from vascular insufficiency of one or both lower limbs and scheduled for above or below knee amputation under general anesthesia.
Who cannot join
- Patients with a history of allergy to local anesthetics.
- Patients with allergy to methylene blue.
- Anticoagulant use or coagulopathy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, Gharbia Governorate, 31527
Osama M Rehab, MD, 00201095210806, osamarehab@med.tanta.edu.eg
Doha M Bakr, MD
About this study
Official title: The Preventive Value of Continuous Perineural Methylene Blue Infusion in Patients Undergoing Lower Limb Amputation Surgery
This prospective randomized controlled study will be conducted to evaluate the analgesic effect of continuous perineural infusion of methylene blue with bupivacaine on acute postoperative pain and to evaluate its preventive role against chronic phantom pain in patients undergoing lower limb amputation surgery
Read the detailed description
Post amputation pain remains an extremely challenging pain condition to treat, so the prevention of phantom pain is our goal to decrease its incidence.
Methylene blue, an inhibitor of nitric oxide synthase and guanylate cyclase, has been widely applied for a variety of pain-related diseases due to its characteristic abilities, such as the blocking of pain transmission, antioxidant, and anti-inflammatory effects. Methylene blue can maintain local anesthesia for approximately 20 days so it can be used as a nerve block to relieve pain, especially refractory neuropathic pain.
- Conditions
- Perineural, Methylene Blue, Lower Limb Amputation
- Being tested
- Bupivacaine methylene blue, bupivacaine saline
- Keywords
- Perineural, Methylene blue, Lower limb amputation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine methylene blueDrug
Patients in this group will receive the following regimen through the perineural catheter:
Bolus dose of 1 ml methylene blue 1% (10 mg) plus 19 ml bupivacaine 0.25% will be given intraoperatively before wound closure, and perineural infusion of methylene blue plus bupivacaine 0.25% (1 ml of methylene blue added to each 49 ml of bupivacaine 0.25%) will be started in the recovery room at a rate of 2-5 ml/hour for 72 hours postoperatively
bupivacaine salineDrug
Patients in this group will receive the following regimen through the perineural catheter:
Bolus dose of 1 ml normal saline plus 19 ml bupivacaine 0.25% will be given intraoperatively before wound closure, and perineural infusion of bupivacaine 0.25% will be started in the recovery room at a rate of 2-5 ml/hour for 72 hours postoperatively
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine methylene blue group | Experimental | Patients in this group will receive the following regimen through the perineural catheter:
Bolus dose of 1 ml methylene blue 1% (10 mg) plus 19 ml bupivacaine 0.25% will be given intraoperatively before wound closure, and perineural infusion of methylene blue plus bupivacaine 0.25% (1 ml of methylene blue added to each 49 ml of bupivacaine 0.25%) will be started in the recovery room at a rate of 2-5 ml/hour for 72 hours postoperatively Receives: Drug: Bupivacaine methylene blue |
| Bupivacaine saline group | Active comparator | Patients in this group will receive the following regimen through the perineural catheter:
Bolus dose of 1 ml normal saline plus 19 ml bupivacaine 0.25% will be given intraoperatively before wound closure, and perineural infusion of bupivacaine 0.25% will be started in the recovery room at a rate of 2-5 ml/hour for 72 hours postoperatively Receives: Drug: bupivacaine saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of postoperative pain
Degree of postoperative pain will be assessed using visual analogue scale which is a 10 cm scale ranging from (0 = no pain to 10 = worst possible pain)
Measured: 3 days after surgery
Secondary outcomes (1)
Incidence of phantom limb pain
Incidence of phantom limb pain at day 6 after surgery then at 1, 3, 6, 9 months after surgery
Measured: 9 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start1 May 2023
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PerineuralStudies of the same condition, open and under way.
- More trials run by Tanta 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Rehab, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830630
- Sponsor's protocol ID
- 36264PR174/4/23
- Status last verified
- Jul 2026
- First submitted
- 14 Apr 2023
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Preventive Value of Continuous Perineural Methylene Blue Infusion in Patients Undergoing Lower Limb Amputation Surgery
- ClinicalTrials.gov ID
- NCT05830630
- Acronym / sponsor ID
- 36264PR174/4/23
- Conditions
- Perineural, Methylene Blue, Lower Limb Amputation
- Keywords
- Perineural, Methylene blue, Lower limb amputation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 26 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.
This prospective randomized controlled study will be conducted to evaluate the analgesic effect of continuous perineural infusion of methylene blue with bupivacaine on acute postoperative pain and to evaluate its preventive role against chronic phantom pain in patients undergoing lower limb amputation surgery
Detailed description
Post amputation pain remains an extremely challenging pain condition to treat, so the prevention of phantom pain is our goal to decrease its incidence.
Methylene blue, an inhibitor of nitric oxide synthase and guanylate cyclase, has been widely applied for a variety of pain-related diseases due to its characteristic abilities, such as the blocking of pain transmission, antioxidant, and anti-inflammatory effects. Methylene blue can maintain local anesthesia for approximately 20 days so it can be used as a nerve block to relieve pain, especially refractory neuropathic pain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine methylene blue group | Experimental | Drug: Bupivacaine methylene bluePatients in this group will receive the following regimen through the perineural catheter: Bolus dose of 1 ml methylene blue 1% (10 mg) plus 19 ml bupivacaine 0.25% will be given intraoperatively before wound closure, and perineural infusion of methylene blue plus bupivacaine 0.25% (1 ml of methylene blue added to each 49 ml of bupivacaine 0.25%) will be started in the recovery room at a rate of 2-5 ml/hour for 72 hours postoperatively |
| Bupivacaine saline group | Active comparator | Drug: bupivacaine salinePatients in this group will receive the following regimen through the perineural catheter: Bolus dose of 1 ml normal saline plus 19 ml bupivacaine 0.25% will be given intraoperatively before wound closure, and perineural infusion of bupivacaine 0.25% will be started in the recovery room at a rate of 2-5 ml/hour for 72 hours postoperatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients of both genders, suffering from vascular insufficiency of one or both lower limbs and scheduled for above or below knee amputation under general anesthesia.
Key exclusion criteria (3 listed)
- Patients with a history of allergy to local anesthetics.
- Patients with allergy to methylene blue.
- Anticoagulant use or coagulopathy.
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 methylene bluePatients in this group will receive the following regimen through the perineural catheter: Bolus dose of 1 ml methylene blue 1% (10 mg) plus 19 ml bupivacaine 0.25% will be given intraoperatively before wound closure, and perineural infusion of methylene blue plus bupivacaine 0.25% (1 ml of methylene blue added to each 49 ml of bupivacaine 0.25%) will be started in the recovery room at a rate of 2-5 ml/hour for 72 hours postoperatively | Drug | Bupivacaine methylene blue group |
| bupivacaine salinePatients in this group will receive the following regimen through the perineural catheter: Bolus dose of 1 ml normal saline plus 19 ml bupivacaine 0.25% will be given intraoperatively before wound closure, and perineural infusion of bupivacaine 0.25% will be started in the recovery room at a rate of 2-5 ml/hour for 72 hours postoperatively | Drug | Bupivacaine saline group |
Primary outcome
Degree of postoperative pain
Time frame: 3 days after surgery
Degree of postoperative pain will be assessed using visual analogue scale which is a 10 cm scale ranging from (0 = no pain to 10 = worst possible pain)
1 secondary outcome
Incidence of phantom limb pain
Time frame: 9 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine methylene blue and bupivacaine saline in people with Perineural and Methylene Blue, run by Tanta 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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 6 Jul 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Osama M Rehab, MD (00201095210806, osamarehab@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of postoperative pain (time frame: 3 days after surgery). 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 6 Jul 2026.