Anesthesia, RegionalNCT03155568
Safety and Efficacy of Three Local Block Techniques for Diabetic Foot Surgery
A study testing sciatic nerve block, ankle block and Bupivacaine in people with Anesthesia, Regional, run by Assiut University.
Trial summary
Diabetic patients suffering diabetic foot disease have sever comorbidities, as hypertension, ischemic heart disease, autonomic neuropathy, infections and gastric reflux all of which contribute to a high risk profile for anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anesthesia, Regional
- What is being tested?
- sciatic nerve block, ankle block and Bupivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2017to 1 Dec 2017
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) II and III
- Co-operative
- Diabetic patients
- Scheduled for various types of elective diabetic unilateral foot operations
Who cannot join
- Patients suffering psychiatric neurological or neuromuscular disorders.
- Allergy to local anesthetics used.
- Infection at the block site.
- Sever renal and hepatic impairment.
- Patients receiving chronic analgesic therapy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Safety and Efficacy of Single Ankle, Single Popliteal or Combined Ankle and Popliteal Block for Diabetic Foot Surgery: A Comparative Study
Diabetic patients suffering diabetic foot disease have sever comorbidities, as hypertension, ischemic heart disease, autonomic neuropathy, infections and gastric reflux all of which contribute to a high risk profile for anesthesia.
failure rate associated with ankle or popliteal nerve block may be higher than accepted, the study hypothesized that combined ankle and popliteal block may increase the success rate with no added complications.
Read the detailed description
Diabetic patients suffering diabetic foot disease regularly have sever co-morbidities, they are more liable to hypertension, ischemic heart disease, autonomic neuropathy, infections and gastric reflux all of which contribute to a high risk profile for anesthesia according to American society of anesthesiologists patients classification.
Anesthetic management for diabetic foot disease surgery is a frequent challenge and should be undertaken with a careful consideration of the anesthetic techniques available.
Hazards of general anesthesia is more likely in diabetic patients as they have low reserves to preserve against additional straining factors during general anesthesia consequently, avoiding general anesthesia in this population may be a central concern to ensure optimal peri-operative management following lower limb surgery. Neuraxial anesthesia is complicated by urinary retention, hypotension and postdural puncture headache and backache. In chronic ischemic legs, with multiple and diffuse stenosis in the leg segmental vessels, hypotension can precipitate thrombosis easily. In addition fluid loading and vasopressor administration may not be ideal methods to treat hypotension since end stage renal disease and coronary artery occlusive disease are common in these patients.
Relative to central nerve block, peripheral limb blocks are more discriminatory in their action and consequently result in less interference of bladder function and motor impairments. Also with peripheral nerve block, patients do not require postoperative fasting that help in preserving patient glycemic control. Moreover. Nerve block anesthesia has the advantages of improved postoperative pain control and it is more economical reducing hospital and associated expenses.
Ankle block alone has high failure rate and require more than usual dose to get effective. In popliteal block larger dose is needed than ankle and there is more time delay. The investigators thought to get the advantages of using local than general anesthesia with combined ankle and popliteal blocks to increase potentiation and decrease doses in diabetic foot surgery.
Aim of the study is to compare between single ankle, single popliteal and combined ankle popliteal block in diabetic patients undergoing elective foot surgery to determine block success rate, safety and efficacy to find the method of better outcome and lesser side effects.
- Conditions
- Anesthesia, Regional
- Being tested
- sciatic nerve block, ankle block, Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sciatic nerve blockProcedure or surgery
sciatic nerve block at popliteal fossa
ankle blockProcedure or surgery
block of major nerves supplying the foot at the level of the ankle
BupivacaineDrug
blocking the lower limb nerve supply at the level of the popliteal fossa and ankle using the local anesthetic bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| sciatic nerve block | Active comparator | ultrasound guided sciatic nerve block by injecting 30ml of 0.5% bupivacaine and visualized circumferentially spreading around the sciatic nerve Receives: Procedure: sciatic nerve block; Drug: Bupivacaine |
| ankle block | Active comparator | ankle block performed by injecting 20 ml of 0.5% bupivacaine in equal amounts around the five major nerves supplying the foot Receives: Procedure: ankle block; Drug: Bupivacaine |
| combined popliteal and ankle block | Active comparator | combined block performed by the use of 20 ml of 0.25% bupivacaine for sciatic nerve block followed by the ankle block with use of 20 ml of 0.5% bupivacaine both in the same manner as other two groups. Receives: Procedure: sciatic nerve block; Procedure: ankle block; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
failure rate
number of patients converted to general anesthesia
Measured: from the time of randomization until 5 days postoperatively
Secondary outcomes (4)
The onset of sensory block
Loss of sensation to pin- prick
Measured: from the time of randomization until 5 days postoperatively
The onset of motor block
complete inability to move the foot
Measured: from the time of randomization until 5 days postoperatively
duration of sensory block
duration till return in any sensation in the distribution of blocked nerve
Measured: from the time of randomization until 5 days postoperatively
Duration of motor blockade
duration till return of motor function
Measured: from the time of randomization until 5 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start15 Jun 2017 (estimated)
- Primary completion1 Nov 2017 (estimated)
- Study completion1 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, RegionalStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Abdel-Baky Abdel-Rahman, Assiut University
- Investigators
- Jehan S Ahmed, MD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03155568
- Sponsor's protocol ID
- IRB00008718/ref.no2015
- Status last verified
- May 2017
- First submitted
- 10 May 2017
- Last updated
- 15 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Single Ankle, Single Popliteal or Combined Ankle and Popliteal Block for Diabetic Foot Surgery: A Comparative Study
- ClinicalTrials.gov ID
- NCT03155568
- Acronym / sponsor ID
- IRB00008718/ref.no2015
- Conditions
- Anesthesia, Regional
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jun 2017 (estimated)
- Primary completion
- 1 Nov 2017 (estimated)
- Study completion
- 1 Dec 2017 (estimated)
- First posted
- 16 May 2017 (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.
Diabetic patients suffering diabetic foot disease have sever comorbidities, as hypertension, ischemic heart disease, autonomic neuropathy, infections and gastric reflux all of which contribute to a high risk profile for anesthesia.
failure rate associated with ankle or popliteal nerve block may be higher than accepted, the study hypothesized that combined ankle and popliteal block may increase the success rate with no added complications.
Detailed description
Diabetic patients suffering diabetic foot disease regularly have sever co-morbidities, they are more liable to hypertension, ischemic heart disease, autonomic neuropathy, infections and gastric reflux all of which contribute to a high risk profile for anesthesia according to American society of anesthesiologists patients classification.
Anesthetic management for diabetic foot disease surgery is a frequent challenge and should be undertaken with a careful consideration of the anesthetic techniques available.
Hazards of general anesthesia is more likely in diabetic patients as they have low reserves to preserve against additional straining factors during general anesthesia consequently, avoiding general anesthesia in this population may be a central concern to ensure optimal peri-operative management following lower limb surgery. Neuraxial anesthesia is complicated by urinary retention, hypotension and postdural puncture headache and backache. In chronic ischemic legs, with multiple and diffuse stenosis in the leg segmental vessels, hypotension can precipitate thrombosis easily. In addition fluid loading and vasopressor administration may not be ideal methods to treat hypotension since end stage renal disease and coronary artery occlusive disease are common in these patients.
Relative to central nerve block, peripheral limb blocks are more discriminatory in their action and consequently result in less interference of bladder function and motor impairments. Also with peripheral nerve block, patients do not require postoperative fasting that help in preserving patient glycemic control. Moreover. Nerve block anesthesia has the advantages of improved postoperative pain control and it is more economical reducing hospital and associated expenses.
Ankle block alone has high failure rate and require more than usual dose to get effective. In popliteal block larger dose is needed than ankle and there is more time delay. The investigators thought to get the advantages of using local than general anesthesia with combined ankle and popliteal blocks to increase potentiation and decrease doses in diabetic foot surgery.
Aim of the study is to compare between single ankle, single popliteal and combined ankle popliteal block in diabetic patients undergoing elective foot surgery to determine block success rate, safety and efficacy to find the method of better outcome and lesser side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sciatic nerve block | Active comparator | Procedure: sciatic nerve block, Drug: Bupivacaineultrasound guided sciatic nerve block by injecting 30ml of 0.5% bupivacaine and visualized circumferentially spreading around the sciatic nerve |
| ankle block | Active comparator | Procedure: ankle block, Drug: Bupivacaineankle block performed by injecting 20 ml of 0.5% bupivacaine in equal amounts around the five major nerves supplying the foot |
| combined popliteal and ankle block | Active comparator | Procedure: sciatic nerve block, Procedure: ankle block, Drug: Bupivacainecombined block performed by the use of 20 ml of 0.25% bupivacaine for sciatic nerve block followed by the ankle block with use of 20 ml of 0.5% bupivacaine both in the same manner as other two groups. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists (ASA) II and III
- Co-operative
- Diabetic patients
- Scheduled for various types of elective diabetic unilateral foot operations
Key exclusion criteria (5 listed)
- Patients suffering psychiatric neurological or neuromuscular disorders.
- Allergy to local anesthetics used.
- Infection at the block site.
- Sever renal and hepatic impairment.
- Patients receiving chronic analgesic therapy.
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 |
|---|---|---|
| sciatic nerve blocksciatic nerve block at popliteal fossa | Procedure or surgery | combined popliteal and ankle block, sciatic nerve block |
| ankle blockblock of major nerves supplying the foot at the level of the ankle | Procedure or surgery | ankle block, combined popliteal and ankle block |
| Bupivacaineblocking the lower limb nerve supply at the level of the popliteal fossa and ankle using the local anesthetic bupivacaine | Drug | ankle block, combined popliteal and ankle block, sciatic nerve block |
Primary outcome
failure rate
Time frame: from the time of randomization until 5 days postoperatively
number of patients converted to general anesthesia
4 secondary outcomes
The onset of sensory block
Time frame: from the time of randomization until 5 days postoperatively
The onset of motor block
Time frame: from the time of randomization until 5 days postoperatively
duration of sensory block
Time frame: from the time of randomization until 5 days postoperatively
Duration of motor blockade
Time frame: from the time of randomization until 5 days postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
- 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.
Jehan S Ahmed, MD study director
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing sciatic nerve block, ankle block and Bupivacaine in people with Anesthesia, Regional, 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 4 inclusion and 5 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 15 Jun 2017. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact khaled A Abdel-Rahman, MD (+2 088 413201, khbaqy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
failure rate (time frame: from the time of randomization until 5 days postoperatively). 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 15 Jun 2017.