PainPhase 4NCT02576782
Dexamethasone & Bupivacaine vs Bupivacaine Alone in Combined Femoral and Sciatic Nerve Block for Perioperative Analgesia in Patients Undergoing Lower Limb Surgeries
A Phase 4 study testing Perineural Dexamethasone and bupivacaine, Systemic Dexamethasone plus perineural bupivacaine and intravenous saline plus perineural bupivacaine in people with Pain, run by Sherif Mohamed Abd el moneim Soaida, MD.
Trial summary
In regional anesthesia local anaesthetics alone provide analgesia for not more than 4-8 hours. Increasing the duration of local anaesthetic action is often desirable because it prolongs surgical anaesthesia and analgesia. Different additives have been used to prolong regional blockade. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain
- What is being tested?
- Perineural Dexamethasone and bupivacaine, Systemic Dexamethasone plus perineural bupivacaine and intravenous saline plus perineural bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Jan 2015
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ranging from 18 to 70 years
- American Society of Anesthesiologists (ASA) physical status I, II and III
- Patients scheduled for lower limb vascular surgeries
Who cannot join
- Patient refusal for the procedure
- Any bleeding disorder or patients on anticoagulant therapy
- Neurological deficits involving lumbar or sacral plexuses
- Patients with allergy to local anaesthetics
- Local infection at the injection site
- Patients on any sedative or antipsychotic drugs
- Body mass index > 35
About this study
Official title: Combination of Dexamethasone and Bupivacaine Versus Bupivacaine Alone in Combined Femoral and Sciatic Nerve Block for Intraoperative and Postoperative Analgesia in Patients Undergoing Lower Limb Vascular Surgeries
In regional anesthesia local anaesthetics alone provide analgesia for not more than 4-8 hours. Increasing the duration of local anaesthetic action is often desirable because it prolongs surgical anaesthesia and analgesia. Different additives have been used to prolong regional blockade. Vasoconstrictors can be used to constrict vessels, thereby reducing vascular absorption of the local anaesthetic. Additives like opioids, clonidine and verapamil were added to local anaesthetics, but the results are either inconclusive or associated with side effects. Steroids when used intrathecally are reported to cause arachnoiditis, but there is no evidence suggesting any neuritis when steroids are used in low concentration in peripheral nerve blocks.
Steroids have powerful anti-inflammatory as well as analgesic properties. Perineural injection of steroids is reported to influence postoperative analgesia. They relieve pain by reducing inflammation, and blocking transmission of nociceptive C-fibres and by suppressing ectopic neural discharge. The addition of 5 mg of dexamethasone to 10 ml of 0.5% levobupivacaine in interscalene brachial plexus block showed improvement of postoperative analgesia for arthroscopic shoulder operation without any specific complications.
Read more
The objective of this study is to compare the effects of combining of dexamethasone and bupivacaine versus bupivacaine alone in combined femoral and sciatic nerve block in patients undergoing lower limb vascular surgeries. The effects will be studied in terms of:
- Onset of sensory blockade and motor blockade
- Duration of analgesia / first request for analgesic
- Duration of motor blockade
- Conditions
- Pain
- Being tested
- Perineural Dexamethasone and bupivacaine, Systemic Dexamethasone plus perineural bupivacaine, intravenous saline plus perineural bupivacaine
- Keywords
- regional anesthesia, dexamethasone, bupivacaine, femoral, sciatic
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perineural Dexamethasone and bupivacaineDrug
Systemic Dexamethasone plus perineural bupivacaineDrug
intravenous saline plus perineural bupivacaineDrug
| Study group | Role | What they receive |
|---|---|---|
| perineural dexamethasone group | Active comparator | 21 patients received perineural dexamethasone plus bupivacaine 0.5% Receives: Drug: Perineural Dexamethasone and bupivacaine |
| systemic dexamethasone group | Active comparator | 21 patients received systemic (intravenous) dexamethasone plus perineural bupivacaine 0.5% Receives: Drug: Systemic Dexamethasone plus perineural bupivacaine |
| control group | Sham comparator | 21 patients received only perineural bupivacaine 0.5% plus intravenous saline Receives: Drug: intravenous saline plus perineural bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of onset of sensory blockade
from time of performing the nerve block till the occurrence of sensory block
Measured: upto 30 min
Time of onset of motor blockade
from time of performing the nerve block till the occurrence of motor block
Measured: up to 30 min
Duration of analgesia
time from onset of analgesia till the first request for an analgesic
Measured: upto 24 hours
Duration of motor blockade
time from motor blockade till ability to move the limb
Measured: upto 24 hours
Secondary outcomes (1)
perioperative hemodynamics
systolic and diastolic blood pressure, heart rate before starting the procedure;Respiratory rate;and Oxygen saturation during the procedure and in the 24 hours following the procedure
Measured: time immediately before block and every 30 minutes till end of surgery and 24 hours after surgery (1 hour interval)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study startJun 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sherif Mohamed Abd el moneim Soaida, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sherif Mohamed Abd el moneim Soaida, MD, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02576782
- Sponsor's protocol ID
- SMS2015-1
- Status last verified
- Oct 2015
- First submitted
- 8 Oct 2015
- Last updated
- 15 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Dexamethasone and Bupivacaine Versus Bupivacaine Alone in Combined Femoral and Sciatic Nerve Block for Intraoperative and Postoperative Analgesia in Patients Undergoing Lower Limb Vascular Surgeries
- ClinicalTrials.gov ID
- NCT02576782
- Acronym / sponsor ID
- SMS2015-1
- Conditions
- Pain
- Keywords
- regional anesthesia, dexamethasone, bupivacaine, femoral, sciatic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Sherif Mohamed Abd el moneim Soaida, MDUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 15 Oct 2015 (estimated)
- 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.
In regional anesthesia local anaesthetics alone provide analgesia for not more than 4-8 hours. Increasing the duration of local anaesthetic action is often desirable because it prolongs surgical anaesthesia and analgesia. Different additives have been used to prolong regional blockade. Vasoconstrictors can be used to constrict vessels, thereby reducing vascular absorption of the local anaesthetic. Additives like opioids, clonidine and verapamil were added to local anaesthetics, but the results are either inconclusive or associated with side effects. Steroids when used intrathecally are reported to cause arachnoiditis, but there is no evidence suggesting any neuritis when steroids are used in low concentration in peripheral nerve blocks.
Steroids have powerful anti-inflammatory as well as analgesic properties. Perineural injection of steroids is reported to influence postoperative analgesia. They relieve pain by reducing inflammation, and blocking transmission of nociceptive C-fibres and by suppressing ectopic neural discharge. The addition of 5 mg of dexamethasone to 10 ml of 0.5% levobupivacaine in interscalene brachial plexus block showed improvement of postoperative analgesia for arthroscopic shoulder operation without any specific complications.
The objective of this study is to compare the effects of combining of dexamethasone and bupivacaine versus bupivacaine alone in combined femoral and sciatic nerve block in patients undergoing lower limb vascular surgeries. The effects will be studied in terms of:
- Onset of sensory blockade and motor blockade
- Duration of analgesia / first request for analgesic
- Duration of motor blockade
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| perineural dexamethasone group | Active comparator | Drug: Perineural Dexamethasone and bupivacaine21 patients received perineural dexamethasone plus bupivacaine 0.5% |
| systemic dexamethasone group | Active comparator | Drug: Systemic Dexamethasone plus perineural bupivacaine21 patients received systemic (intravenous) dexamethasone plus perineural bupivacaine 0.5% |
| control group | Sham comparator | Drug: intravenous saline plus perineural bupivacaine21 patients received only perineural bupivacaine 0.5% plus intravenous saline |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ranging from 18 to 70 years
- American Society of Anesthesiologists (ASA) physical status I, II and III
- Patients scheduled for lower limb vascular surgeries
Key exclusion criteria (7 listed)
- Patient refusal for the procedure
- Any bleeding disorder or patients on anticoagulant therapy
- Neurological deficits involving lumbar or sacral plexuses
- Patients with allergy to local anaesthetics
- Local infection at the injection site
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 |
|---|---|---|
| Perineural Dexamethasone and bupivacaine | Drug | perineural dexamethasone group |
| Systemic Dexamethasone plus perineural bupivacaine | Drug | systemic dexamethasone group |
| intravenous saline plus perineural bupivacaine | Drug | control group |
Primary outcome
Time of onset of sensory blockade
Time frame: upto 30 min
from time of performing the nerve block till the occurrence of sensory block
Time of onset of motor blockade
Time frame: up to 30 min
from time of performing the nerve block till the occurrence of motor block
Duration of analgesia
Time frame: upto 24 hours
time from onset of analgesia till the first request for an analgesic
Duration of motor blockade
Time frame: upto 24 hours
time from motor blockade till ability to move the limb
1 secondary outcome
perioperative hemodynamics
Time frame: time immediately before block and every 30 minutes till end of surgery and 24 hours after surgery (1 hour interval)
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 15 Oct 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Perineural Dexamethasone and bupivacaine, Systemic Dexamethasone plus perineural bupivacaine and intravenous saline plus perineural bupivacaine in people with Pain, run by Sherif Mohamed Abd el moneim Soaida, MD.
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 7 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 15 Oct 2015. 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?
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?
Time of onset of sensory blockade (time frame: upto 30 min). The study lists 4 primary outcomes in all. 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 Oct 2015; AzTrials last refreshed its copy on 8 Nov 2026.