The aim of this study is to evaluate the analgesic efficacy of fascia iliaca compartment block using bupivacaine versus bupivacaine with dexamethasone or magnesium sulphate for dynamic hip screw surgery under spinal anesthesia.
The primary outcome will be the duration of effective analgesia from FICB till the first analgesic dose is required,the secondary outcomes will be the severity of postoperative pain as will be assessed by the visual analogue scale and the total dose of pethidin for rescue analgesia.
Condition or disease | Intervention/treatment | Phase |
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Analgesia | Drug: Bupivacaine Drug: Dexamethasone/bupivacaine Drug: Magnesium Sulfate/bupivacaine | Phase 1 |
Different modes of analgesia are given prior to neuraxial blockade for pain relief like non-steroidal anti-inflammatory drugs (NSAID), opioids and peripheral nerve blocks such as, femoral nerve block, 3 in 1 block or fascia iliaca compartment block (FICB).
FICB is believed to be most beneficial compared to other procedures because of its safety and efficacy . FICB provides blockage of at least two of the three major nerves that supply the medial, anterior and lateral thigh with one simple injection, namely the femoral and lateral femoral cutaneous nerves.
FICB is an anterior approach to the lumbar plexus. The pop technique using fascial click had a low success rate of 35% - 47% .However, as the FICB was performed under real-time ultrasound guidance, the success rate was increased up to 82- 87%, leading to an increased interest in FICB as a postoperative analgesia option for hip and knee surgical procedures .
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Care Provider) |
Masking Description: | The anesthetists who will prepare the drug and who will collect the data will be blinded to the study protocol |
Primary Purpose: | Treatment |
Official Title: | Analgesic Efficacy of Fascia Iliaca Compartment Block With Bupivacaine Versus Bupivacaine With Dexamethasone or Magnesium Sulphate for Dynamic Hip Screw Surgeries Randomized Double Blinded Comparative Study |
Estimated Study Start Date : | May 2019 |
Estimated Primary Completion Date : | December 2019 |
Estimated Study Completion Date : | December 2019 |
Arm | Intervention/treatment |
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Placebo Comparator: the control group
Ultrasound guided fascia iliaca compartment block (FICB) will be performed using 28 ml bupivacaine 0.25% + 2 ml of normal saline (total volume 30 ml).(
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Drug: Bupivacaine
Ultrasound guided fascia iliaca compartment block (FICB) will be performed using 28 ml bupivacaine 0.25% + 2 ml of normal saline (total volume 30 ml).(
Other Name: Marcain
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Active Comparator: Group dexamethasone/Bupivacaine:
Ultrasound guided fascia iliaca compartment block (FICB) will be performed using with 28 ml bupivacaine 0.25% + 2 ml dexamethasone (8mg) (total volume 30 ml).(
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Drug: Dexamethasone/bupivacaine
Ultrasound guided fascia iliaca compartment block (FICB) will be performed with 28 ml bupivacaine 0.25% + 2 ml dexamethasone (8mg) (total volume 30 ml)d using
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Active Comparator: Group Magnesium sulphate/Bupivacaine
Ultrasound guided fascia iliaca compartment block (FICB) will be performed using 28 ml bupivacaine 0.25% + 2 ml magnesium sulphate (200mg) (total volume 30 ml).
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Drug: Magnesium Sulfate/bupivacaine
Ultrasound guided fascia iliaca compartment block (FICB) will be performed using 28 ml bupivacaine 0.25% + 2 ml magnesium sulphate (200mg) (total volume 30 ml).
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Ages Eligible for Study: | 20 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Samaa Rashwan, MD | 020120159125 | samakassemrashwan@gmail.com |
Egypt | |
Beni-Suef University Hospital | Recruiting |
Banī Suwayf, Egypt | |
Contact: Samaa Rashwan, MD 0201270159125 |
Principal Investigator: | Samaa Rashwan, MD | Assisstant proffesor of anesthesia |
Tracking Information | |||||
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First Submitted Date ICMJE | May 13, 2019 | ||||
First Posted Date ICMJE | May 21, 2019 | ||||
Last Update Posted Date | May 21, 2019 | ||||
Estimated Study Start Date ICMJE | May 2019 | ||||
Estimated Primary Completion Date | December 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Analgesia [ Time Frame: duration from the end of surgery till the first time to ask for post operative analgesia within the first 12 hours after surgery ] the duration of effective analgesia will be considered as the duration after performing the FICB till the patient ask for first analgesic dose ,in this case pethidin 25 mg will be given intravenously
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Analgesic Efficacy of Fascia Iliaca Compartment Block | ||||
Official Title ICMJE | Analgesic Efficacy of Fascia Iliaca Compartment Block With Bupivacaine Versus Bupivacaine With Dexamethasone or Magnesium Sulphate for Dynamic Hip Screw Surgeries Randomized Double Blinded Comparative Study | ||||
Brief Summary |
The aim of this study is to evaluate the analgesic efficacy of fascia iliaca compartment block using bupivacaine versus bupivacaine with dexamethasone or magnesium sulphate for dynamic hip screw surgery under spinal anesthesia. The primary outcome will be the duration of effective analgesia from FICB till the first analgesic dose is required,the secondary outcomes will be the severity of postoperative pain as will be assessed by the visual analogue scale and the total dose of pethidin for rescue analgesia. |
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Detailed Description |
Different modes of analgesia are given prior to neuraxial blockade for pain relief like non-steroidal anti-inflammatory drugs (NSAID), opioids and peripheral nerve blocks such as, femoral nerve block, 3 in 1 block or fascia iliaca compartment block (FICB). FICB is believed to be most beneficial compared to other procedures because of its safety and efficacy . FICB provides blockage of at least two of the three major nerves that supply the medial, anterior and lateral thigh with one simple injection, namely the femoral and lateral femoral cutaneous nerves. FICB is an anterior approach to the lumbar plexus. The pop technique using fascial click had a low success rate of 35% - 47% .However, as the FICB was performed under real-time ultrasound guidance, the success rate was increased up to 82- 87%, leading to an increased interest in FICB as a postoperative analgesia option for hip and knee surgical procedures . |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Care Provider) Masking Description: The anesthetists who will prepare the drug and who will collect the data will be blinded to the study protocol Primary Purpose: Treatment
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Condition ICMJE | Analgesia | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
60 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 2019 | ||||
Estimated Primary Completion Date | December 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 20 Years to 70 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Egypt | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03957499 | ||||
Other Study ID Numbers ICMJE | Beni-Suef Faculty of Medicine | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Samaa Rashwan, Beni-Suef University | ||||
Study Sponsor ICMJE | Samaa Rashwan | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Beni-Suef University | ||||
Verification Date | May 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |