Perioperative PainNCT05393726
Suprainguinal Fascia Iliaca Block Versus Lumbar Erector Spinae Plane Block for Oncologic Thigh Surgery
A study testing Ultrasound-Guided Suprainguinal Fascia Iliaca Block Versus Lumbar Erector Spinae Plane Block in people with Perioperative Pain, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
This is a prospective; double blinded randomized controlled trial that will be conducted on cancer patients subjected to oncologic thigh surgery.The aim of this study is to evaluate and compare the analgesic effect of supra-inguinal fascia iliaca block and lumbar erector spinae plane block in oncologic thigh… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Perioperative Pain
- What is being tested?
- Ultrasound-Guided Suprainguinal Fascia Iliaca Block Versus Lumbar Erector Spinae Plane Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 30 Sep 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-65 years.
- Physical status: ASA II,III
- Patient undergoing oncologic thigh surgery under general anesthesia.
- Body mass index (BMI): 20-40 kg/m 2
Who cannot join
- Patient refusal.
- Sensitivity or contraindication to local anesthetics.
- Bleeding tendency due to coagulopathy.
- Patients with opioid dependence or alcohol or drug abuse.
- Patients with psychiatric illness that prevent them from proper perception and assessment of pain.
- Contraindication to regional anesthesia e.g. local infection at the site of block, coagulopathy with INR more than 1.6: hereditary (e.g. hemophilia, fibrinogen abnormalities \& deficiency factor II) acquired (e.g. impaired liver functions with PC less than 60%, vitamin K deficiency \& therapeutic anticoagulant drugs) .
- Significant renal insufficiency (plasma creatinine more than 1.5 mg/dl).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-Guided Suprainguinal Fascia Iliaca Block Versus Lumbar Erector Spinae Plane Block for Oncologic Thigh Surgery: A Randomized Controlled Trial
This is a prospective; double blinded randomized controlled trial that will be conducted on cancer patients subjected to oncologic thigh surgery.The aim of this study is to evaluate and compare the analgesic effect of supra-inguinal fascia iliaca block and lumbar erector spinae plane block in oncologic thigh surgery.Patients will be randomized into three equal comparable groups, Group A (Ultrasound-guided supra-inguinal fascia iliaca block (SIFIB)), Group B (Ultrasound-guided lumbar erector spinae plane block (L-ESPB)), and Group C (control group). Primary outcome parameter is the total postoperative morphine consumption over the first 24 hours postoperative. Data will be analyzed using IBM SPSS 26 (SPSS Inc., Chicago, IL).
Read the detailed description
Pain is one of the most common and significant postoperative events experienced by many surgical patients. Orthopedic surgery is a relatively painful surgery due to the significant amount of bone and soft tissue resection, damage, and reconstruction. After thigh surgery for sarcomas, the patient may experience any of three distinct types of pain, including acute postoperative pain, persistent long-term nociceptive pain, and neuropathic pain related to intraoperative nerve injuries. The management of pain in limb sparing surgery patients and amputated patients is crucial during the rehabilitation program and often its approach is multidisciplinary. The ultrasound-guided supra-inguinal fascia iliaca block further built on earlier anatomic discoveries to more reliably anesthetize the three nerves: femoral, lateral femoral cutaneous, and obturator. The supra-inguinal fascia iliaca block has evolved as an effective means of providing analgesia to the thigh, the knee, and, most notably, the hip. Ultrasound-guided erector spinae plane block (ESPB) is an interfascial plane block reported in the treatment of postoperative pain from surgical procedures, ranging from shoulder to hip surgery. When performed at the lumbar 4th vertebral level, ESPB led to sensorial blockage between Th12 and L4 dermatomes lead to effective postoperative analgesia in hip and proximal femoral surgery. Although supra-inguinal fascia iliaca block and L-ESPB successfully reduced postoperative opioid consumption in previous study, no study has ever compared their efficacy in postoperative analgesia of adult patients undergoing oncologic thigh surgery under general anesthesia. Thus, in this randomized comparative study we are aiming to fill this gape in the literature.
- Conditions
- Perioperative Pain
- Being tested
- Ultrasound-Guided Suprainguinal Fascia Iliaca Block Versus Lumbar Erector Spinae Plane Block
- Keywords
- Suprainguinal Fascia Iliaca Block, Lumbar Erector Spinae Plane Block, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Suprainguinal Fascia Iliaca Block Versus Lumbar Erector Spinae Plane BlockProcedure or surgery
Suprainguinal Fascia Iliaca Block group will receive ultrasound-guided suprainguinal fascia iliaca block injection 40 ml of bupivacaine 0.25% mixed with 2 ml of dexamethasone 4 mg/ml.
Lumbar Erector Spinae Plane Block group will receive ultrasound-guided lumber erector spinae plane block (L-ESPB) injection 40 ml bupivacaine 0.25% mixed with 2 ml of dexamethasone 4 mg/ml.
control group will underwent surgery under general anesthesia and receive the perioperative routine protocol of analgesia
| Study group | Role | What they receive |
|---|---|---|
| Suprainguinal Fascia Iliaca Block group | Experimental | Patients will receive ultrasound-guided suprainguinal fascia iliaca block injection 40 ml of bupivacaine 0.25% mixed with 2 ml of dexamethasone 4 mg/ml. Receives: Procedure: Ultrasound-Guided Suprainguinal Fascia Iliaca Block Versus Lumbar Erector Spinae Plane Block |
| Lumbar Erector Spinae Plane Block group | Experimental | Patients will receive ultrasound-guided lumber erector spinae plane block (L-ESPB) injection 40ml bupivacaine 0.25% mixed with 2 ml of dexamethasone 4 mg/ml. Receives: Procedure: Ultrasound-Guided Suprainguinal Fascia Iliaca Block Versus Lumbar Erector Spinae Plane Block |
| control group | No intervention | Patients underwent surgery under general anesthesia and received the perioperative routine protocol of analgesia by using I.V. fentanyl (1µg/kg), with elevation of mean arterial blood pressure for more than 20% of their baseline values, additional bolus doses of fentanyl 0.5 µg /kg. |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative morphine consumption .
Total postoperative morphine consumption over the first 24 hours postoperative.
Measured: over the first 24 hours postoperative
Secondary outcomes (3)
fentanyl consumption.
Total intra-operative fentanyl consumption.
Measured: intra-operative
The time of first rescue analgesia.
The time of first rescue analgesia.
Measured: over the first 24 hours postoperative
Visual Analogue Scale
Pain will be assessed using Visual Analogue Scale, both at rest and during movement, pain scores using visual Analogue Scale will be recorded in the post anesthesia care unit and for the next 24 hours postoperative.score (0) means no pain, scores(1-3) are considered mild pain, (4-6) moderate pain and (7-10) severe pain
Measured: over the first 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start1 Jun 2022
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamed Sayed Ashour, National Cancer Institute, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393726
- Sponsor's protocol ID
- 2203-301-014
- Status last verified
- Nov 2024
- First submitted
- 22 May 2022
- Last updated
- 5 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Suprainguinal Fascia Iliaca Block Versus Lumbar Erector Spinae Plane Block for Oncologic Thigh Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05393726
- Acronym / sponsor ID
- 2203-301-014
- Conditions
- Perioperative Pain
- Keywords
- Suprainguinal Fascia Iliaca Block, Lumbar Erector Spinae Plane Block, postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 26 May 2022 (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 is a prospective; double blinded randomized controlled trial that will be conducted on cancer patients subjected to oncologic thigh surgery.The aim of this study is to evaluate and compare the analgesic effect of supra-inguinal fascia iliaca block and lumbar erector spinae plane block in oncologic thigh surgery.Patients will be randomized into three equal comparable groups, Group A (Ultrasound-guided supra-inguinal fascia iliaca block (SIFIB)), Group B (Ultrasound-guided lumbar erector spinae plane block (L-ESPB)), and Group C (control group). Primary outcome parameter is the total postoperative morphine consumption over the first 24 hours postoperative. Data will be analyzed using IBM SPSS 26 (SPSS Inc., Chicago, IL).
Detailed description
Pain is one of the most common and significant postoperative events experienced by many surgical patients. Orthopedic surgery is a relatively painful surgery due to the significant amount of bone and soft tissue resection, damage, and reconstruction. After thigh surgery for sarcomas, the patient may experience any of three distinct types of pain, including acute postoperative pain, persistent long-term nociceptive pain, and neuropathic pain related to intraoperative nerve injuries. The management of pain in limb sparing surgery patients and amputated patients is crucial during the rehabilitation program and often its approach is multidisciplinary. The ultrasound-guided supra-inguinal fascia iliaca block further built on earlier anatomic discoveries to more reliably anesthetize the three nerves: femoral, lateral femoral cutaneous, and obturator. The supra-inguinal fascia iliaca block has evolved as an effective means of providing analgesia to the thigh, the knee, and, most notably, the hip. Ultrasound-guided erector spinae plane block (ESPB) is an interfascial plane block reported in the treatment of postoperative pain from surgical procedures, ranging from shoulder to hip surgery. When performed at the lumbar 4th vertebral level, ESPB led to sensorial blockage between Th12 and L4 dermatomes lead to effective postoperative analgesia in hip and proximal femoral surgery. Although supra-inguinal fascia iliaca block and L-ESPB successfully reduced postoperative opioid consumption in previous study, no study has ever compared their efficacy in postoperative analgesia of adult patients undergoing oncologic thigh surgery under general anesthesia. Thus, in this randomized comparative study we are aiming to fill this gape in the literature.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Suprainguinal Fascia Iliaca Block group | Experimental | Procedure: Ultrasound-Guided Suprainguinal Fascia Iliaca Block Versus Lumbar Erector Spinae Plane BlockPatients will receive ultrasound-guided suprainguinal fascia iliaca block injection 40 ml of bupivacaine 0.25% mixed with 2 ml of dexamethasone 4 mg/ml. |
| Lumbar Erector Spinae Plane Block group | Experimental | Procedure: Ultrasound-Guided Suprainguinal Fascia Iliaca Block Versus Lumbar Erector Spinae Plane BlockPatients will receive ultrasound-guided lumber erector spinae plane block (L-ESPB) injection 40ml bupivacaine 0.25% mixed with 2 ml of dexamethasone 4 mg/ml. |
| control group | No intervention | –Patients underwent surgery under general anesthesia and received the perioperative routine protocol of analgesia by using I.V. fentanyl (1µg/kg), with elevation of mean arterial blood pressure for more than 20% of their baseline values, additional bolus doses of fentanyl 0.5 µg /kg. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 18-65 years.
- Physical status: ASA II,III
- Patient undergoing oncologic thigh surgery under general anesthesia.
- Body mass index (BMI): 20-40 kg/m 2
Key exclusion criteria (7 listed)
- Patient refusal.
- Sensitivity or contraindication to local anesthetics.
- Bleeding tendency due to coagulopathy.
- Patients with opioid dependence or alcohol or drug abuse.
- Patients with psychiatric illness that prevent them from proper perception and assessment of pain.
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 |
|---|---|---|
| Ultrasound-Guided Suprainguinal Fascia Iliaca Block Versus Lumbar Erector Spinae Plane BlockSuprainguinal Fascia Iliaca Block group will receive ultrasound-guided suprainguinal fascia iliaca block injection 40 ml of bupivacaine 0.25% mixed with 2 ml of dexamethasone 4 mg/ml. Lumbar Erector Spinae Plane Block group will receive ultrasound-guided lumber erector spinae plane block (L-ESPB) injection 40 ml bupivacaine 0.25% mixed with 2 ml of dexamethasone 4 mg/ml. control group will underwent surgery under general anesthesia and receive the perioperative routine protocol of analgesia | Procedure or surgery | Lumbar Erector Spinae Plane Block group, Suprainguinal Fascia Iliaca Block group |
Primary outcome
postoperative morphine consumption .
Time frame: over the first 24 hours postoperative
Total postoperative morphine consumption over the first 24 hours postoperative.
3 secondary outcomes
fentanyl consumption.
Time frame: intra-operative
The time of first rescue analgesia.
Time frame: over the first 24 hours postoperative
Visual Analogue Scale
Time frame: over the first 24 hours postoperative
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 5 Nov 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Guided Suprainguinal Fascia Iliaca Block Versus Lumbar Erector Spinae Plane Block in people with Perioperative Pain, run by National Cancer Institute, Egypt 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 4 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 5 Nov 2024. 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?
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?
postoperative morphine consumption . (time frame: over the first 24 hours postoperative). 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 5 Nov 2024.