Quadratus lumborum block is a newly developed block with good performance in lower abdominal surgery. In a cadaveric study, the spread of local anesthetic in the anterior approach of QL block (QL3) was reported to cover nerve roots from T10 to L3. Thus, it was hypothesized that this approach could be used in hip surgeries with minimal motor affection.
This study aims to compare QL3 block and suprainguinal Fascia Iliaca block in the duration of postoperative analgesia, pain scores, motor power in quadriceps muscle, and side effects.
Condition or disease | Intervention/treatment | Phase |
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Post Operative Pain | Procedure: quadratus lumborum block; (Anterior QLB or QLB III) Procedure: suprainguinal fascia iliaca block Procedure: Subarachnoid block | Not Applicable |
A randomized, controlled, double blinded, trial will be conducted in Cairo university hospital. Written informed consent will be obtained from all participants. Randomization will be achieved using a computer-generated sequence. Concealment will be achieved using opaque envelopes. Patients scheduled for hip replacement surgeries under subarachnoid block (SAB). e.g. hip hemiarthroplasty, total hip arthroplasty.
On arrival of the patients to regional anesthesia room, patients will be secured with 18-gauge intravenous cannula, and will receive ondansetron (4 mg), and dexamethasone (8 mg IV). Monitoring will include Electrocardiography, non-invasive arterial blood pressure, and pulse oximetry.
Before receiving subarachinoid block, patients will be randomly assigned into one of the two study groups:
QLB Group (n=17): this group will receive ultrasound-guided transmuscular quadratus lumborum block; (Anterior QLB or QLB III) FIB Group (n=17): this group will receive suprainguinal fascia iliaca block To achieve double blinding, patients will receive the block with 30 mL bupivacaine (0.25%) by the anesthetist. Another doctor not involved in the block procedure will evaluate the patients postoperative.
After finishing the block & assessment of motor power of quadriceps femoris muscle , patient will receive midazolam (2mg intravenous), and then transferred to operation room.
Postoperatively, all patients will receive 1 g paracetamol every 6 hours and 30 mg ketorolac every 12 hours.
If the visual analogue scale (VAS) is 4 or more, a 2 mg morphine increment will be added per time to maintain a resting VAS at <3 with maximum total 24-hours morphine 10 mg.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 34 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Quadratus Lumborum Block Versus Fascia Iliaca Block for Hip Arthroplasty: A Randomized Controlled Trial |
Actual Study Start Date : | July 5, 2019 |
Estimated Primary Completion Date : | October 5, 2019 |
Estimated Study Completion Date : | October 15, 2019 |
Arm | Intervention/treatment |
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Experimental: QLB Group
this group will receive ultrasound-guided transmuscular quadratus lumborum block; (Anterior QLB or QLB III)
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Procedure: quadratus lumborum block; (Anterior QLB or QLB III)
The patient will be in the lateral position. A low frequency convex probe will be vertically attached above the iliac crest and a needle will be inserted in plane from the posterior edge of the convex probe through the quadratus lumborum in an anteromedial direction. The needle tip will be placed between the psoas major muscle and the quadratus lumborum muscle. After negative aspiration, 30 mL of 0.25 % of bupivacaine will be injected into the fascial plane incrementally, aspirating every 5 ml.
Procedure: Subarachnoid block Patients will receive SAB using 25g spinal needle in the lateral position. Fifteen milligrams of hyperbaric bupivacaine will be administered at L3-L4 or at L4-L5 interspace in addition to 25 mcg fentanyl with rapid crystalloid co-load. Spinal anesthesia will be considered successful when a bilateral block to T12, as assessed by loss of cold (cold ice) and pain (a 23-gauge needle) sensations, will be established 10 -minutes after the intrathecal injection. If spinal anesthesia failed, such patients will be administered general anesthesia and will be excluded from this study. Other Name: spinal anesthesia
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Experimental: FIB Group
this group will receive suprainguinal fascia iliaca block
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Procedure: suprainguinal fascia iliaca block
In supine position, a high frequency linear probe will be placed in the inguinal crease. Scan starting laterally from the femoral artery and nerve in inguinal crease to identify the sartorius muscle, tracing the muscle until it's origin to anterior superior iliac spine. The shadow of the bony of iliac crest & iliacus muscle will be seen, the end point of the injection is deep to the fascia iliaca and above the iliacus muscle in the lateral part of the iliacus muscle. After negative aspiration, 30 mL of 0.25 % of bupivacaine will be injected under the fascial plane incrementally, aspirating every 5 ml.
Procedure: Subarachnoid block Patients will receive SAB using 25g spinal needle in the lateral position. Fifteen milligrams of hyperbaric bupivacaine will be administered at L3-L4 or at L4-L5 interspace in addition to 25 mcg fentanyl with rapid crystalloid co-load. Spinal anesthesia will be considered successful when a bilateral block to T12, as assessed by loss of cold (cold ice) and pain (a 23-gauge needle) sensations, will be established 10 -minutes after the intrathecal injection. If spinal anesthesia failed, such patients will be administered general anesthesia and will be excluded from this study. Other Name: spinal anesthesia
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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ahmed M. Hasanin, M.D. | +201095076954 | ahmedmohamedhasanin@gmail.com | |
Contact: Mahmoud swilem | +201008855731 | mr.sewilam@gmail.com |
Egypt | |
Anesthesia Department | Recruiting |
Cairo, Egypt, 1772 | |
Contact: Bassant abdelhamid, M.D. 01224254012 bassantmohamed197@yahoo.com | |
Principal Investigator: Ahmed Hassanin, M.D. | |
Sub-Investigator: Mahmoud Swilem |
Principal Investigator: | Ahmed M. Hasanin, M.D. | Cairo University |
Tracking Information | |||||||||
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First Submitted Date ICMJE | June 26, 2019 | ||||||||
First Posted Date ICMJE | July 2, 2019 | ||||||||
Last Update Posted Date | July 8, 2019 | ||||||||
Actual Study Start Date ICMJE | July 5, 2019 | ||||||||
Estimated Primary Completion Date | October 5, 2019 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Duration of analgesia [ Time Frame: 24 hours postoperative ] If the visual analogue scale (VAS) is 4 or more, a 2 mg morphine increment will be added per time to maintain a resting VAS at <3 with maximum total 24-hours morphine 10 mg.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Quadratus Lumborum Block Versus Fascia Iliaca Block for Hip Arthroplasty | ||||||||
Official Title ICMJE | Quadratus Lumborum Block Versus Fascia Iliaca Block for Hip Arthroplasty: A Randomized Controlled Trial | ||||||||
Brief Summary |
Quadratus lumborum block is a newly developed block with good performance in lower abdominal surgery. In a cadaveric study, the spread of local anesthetic in the anterior approach of QL block (QL3) was reported to cover nerve roots from T10 to L3. Thus, it was hypothesized that this approach could be used in hip surgeries with minimal motor affection. This study aims to compare QL3 block and suprainguinal Fascia Iliaca block in the duration of postoperative analgesia, pain scores, motor power in quadriceps muscle, and side effects. |
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Detailed Description |
A randomized, controlled, double blinded, trial will be conducted in Cairo university hospital. Written informed consent will be obtained from all participants. Randomization will be achieved using a computer-generated sequence. Concealment will be achieved using opaque envelopes. Patients scheduled for hip replacement surgeries under subarachnoid block (SAB). e.g. hip hemiarthroplasty, total hip arthroplasty. On arrival of the patients to regional anesthesia room, patients will be secured with 18-gauge intravenous cannula, and will receive ondansetron (4 mg), and dexamethasone (8 mg IV). Monitoring will include Electrocardiography, non-invasive arterial blood pressure, and pulse oximetry. Before receiving subarachinoid block, patients will be randomly assigned into one of the two study groups: QLB Group (n=17): this group will receive ultrasound-guided transmuscular quadratus lumborum block; (Anterior QLB or QLB III) FIB Group (n=17): this group will receive suprainguinal fascia iliaca block To achieve double blinding, patients will receive the block with 30 mL bupivacaine (0.25%) by the anesthetist. Another doctor not involved in the block procedure will evaluate the patients postoperative. After finishing the block & assessment of motor power of quadriceps femoris muscle , patient will receive midazolam (2mg intravenous), and then transferred to operation room. Postoperatively, all patients will receive 1 g paracetamol every 6 hours and 30 mg ketorolac every 12 hours. If the visual analogue scale (VAS) is 4 or more, a 2 mg morphine increment will be added per time to maintain a resting VAS at <3 with maximum total 24-hours morphine 10 mg. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Post Operative Pain | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* 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 | Recruiting | ||||||||
Estimated Enrollment ICMJE |
34 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | October 15, 2019 | ||||||||
Estimated Primary Completion Date | October 5, 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 | 18 Years to 65 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Egypt | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04005326 | ||||||||
Other Study ID Numbers ICMJE | N-144-2018 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Bassant M. Abdelhamid, Cairo University | ||||||||
Study Sponsor ICMJE | Bassant M. Abdelhamid | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Cairo University | ||||||||
Verification Date | July 2019 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |