An interventional study of quadratus lumborum block; (Anterior QLB or QLB III) and suprainguinal fascia iliaca block in Post Operative Pain, sponsored by Bassant M. Abdelhamid. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-07-08.
Sponsored by Bassant M. Abdelhamid · Not applicable, Interventional, and Treatment
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.
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's planned enrollment of 34 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Bassant M. Abdelhamid is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
this group will receive ultrasound-guided transmuscular quadratus lumborum block; (Anterior QLB or QLB III)
Procedure: quadratus lumborum block; (Anterior QLB or QLB III) · Procedure: Subarachnoid block
this group will receive suprainguinal fascia iliaca block
Procedure: suprainguinal fascia iliaca block · Procedure: Subarachnoid block
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.
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.
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.
Also known as: spinal anesthesia
Duration of analgesia
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.
Time frame: 24 hours postoperative
Static visual analogue pain scale
Visual analogue pain scale (VAS) at rest. The pain visual analogue pain scale( VAS) is a continuous scale 10 centimeters (100 mm) in length. The scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 \[100-mm scale\]).
Time frame: 24 hours postoperative
Dynamic visual analogue pain scale
Visual analogue pain scale (VAS) on movement. The pain visual analogue pain scale( VAS) is a continuous scale 10 centimeters (100 mm) in length. The scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 \[100-mm scale\]).
Time frame: 24 hours postoperative
Onset of sensory block of quadratus lumborum block and fascia iliaca block
the time interval between the injection of the study medication till complete loss of sensation
Time frame: 30 minutes
Time to first postoperative analgesic request
morphine increment will be added per time to maintain a resting VAS at \<3 with maximum
Time frame: 24 hours postoperative
Total morphine requirements
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.
Time frame: 24 hours postoperative
Assessment of the quadriceps muscle power.
the patient will be in supine position and the patient's knee will be fully flexed, and the patient will be asked to extend it. The motor block is classified as follows: grade 0; normal muscle power, grade I; motor weakness, grade II; complete motor paralysis
Time frame: 24 hours
Time needed to perform the block
the total time of the procedure (quadratus lumborum block or fascia iliaca block) started from patient positioning till completion of local anesthesia injection.
Time frame: 30 minutes
incidence of pain during positioning for spinal block
to assess the ability of either two types of the the blocks to relieve pain during positioning for spinal anesthesia
Time frame: 30 minutes
Plan to share: No
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Bassant M. Abdelhamid