An interventional study of Bilateral QL block and Non-QL block in Postoperative Pain, sponsored by Indonesia University. Completed at 1 site in Indonesia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-10.
Sponsored by Indonesia University · Not applicable, Interventional, and Supportive care
Quadratus lumborum (QL) block can reduce intraoperative opioid consumption, decrease inflammation responses of IL-6, and reduce acute pain intensity in comparison with non-receiving QL block as the control group.
Quadratus lumborum block had been studied as an effective postoperative analgesia in lower abdominal surgery, due to its spread to the thoracic paravertebral space and thoracolumbar fascia nerve. The effect of preincisional ultrasound (US)-guided QL block as "preemptive analgesia" on patient underwent laparoscopic living donor nephrectomy has never been evaluated. As preemptive analgesia, quadratus lumborum block could provide analgesics before and after surgery. Both groups immediately received basic postoperative analgesia regimen paracetamol 1 gr IV 8th hourly.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 44 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Indonesia University is the lead sponsor of 448 studies on the registry; 56 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Exclusion Criteria:
The control (non-QL block) group only received fentanyl IV during surgery.
Drug: Non-QL block
The patients were in the semi-lateral supine position to show up the side to be blocked. Using USG and 1-6 MHz convex transducer placed in the transverse plane above the iliac crest at the level of the umbilicus. A Stimuplex® 20G 100-mm needle was advanced in anteroposterior direction toward the junction of tapered abdominal muscle layer and QL muscle, and 20 ml of 0.25% bupivacaine was deposited in the anterolateral border of QL muscle at the junction with the transversalis fascia reach outside the anterior layer of transversalis fascia. The lateral approach QL (type I) blocks were performed at both sides of patients. The total amount of bupivacaine was 100 mg for each patient
Drug: Bilateral QL block
Bilateral lateral Quadratus Lumborum block using 20 ml of 0.25% bupivacaine each injection as preemptive analgesia.
Only received fentanyl IV during surgery.
Intraoperative fentanyl consumption
Intraoperative fentanyl consumption was recorded as total consumption in µg, and calculated into mean consumption per hour in µg.kg-1.h-1, due to the influence of patients body weight and duration of surgery to the given dose of fentanyl boluses.
Time frame: Intraoperative
Changes in Interleukin-6 from baseline
Measurement of plasma Interleukin-6 before the anaesthesia induction as the baseline; 2 hours of surgical stimulation and gas insufflation intraoperatively; and 2 hours after recovery from anaesthesia.
Time frame: 24 hours
Numerical Rating Scale
Pain measurement using Numerical Rating Scale (NRS) at rest and during movement. NRS from 0 =no pain to 10= worst pain at 2 hours and 24 hours after anaesthesia recovery
Time frame: 24 hours
Hemodynamic Profiles: Heart Rate in bpm
The trends of perioperative haemodynamic profiles during and after surgery: heart rate in beat per minute
Time frame: Intraoperative
Hemodynamic Profiles: Systolic, Diastolic, and Mean Arterial Pressure in mmHg
The trends of perioperative haemodynamic profiles during and after surgery : systolic, diastolic and mean arterial pressure in mmHg
Time frame: Intraoperative
Number of participants with additional intravenous tramadol
During observation after surgery, when the NRS began to increase \> 3 at rest the intermittent tramadol 50 mg IV boluses was given 8th hourly. If the NRS still remained \> 3, the intermittent tramadol 50 mg IV boluses were administered more frequently up to 4th hourly.
Time frame: 24 hours
Number of participants with additional intravenous fentanyl
If the pain relief was still inadequate after increasing tramadol boluses, the extra fentanyl 1 µg.kg\^-1 IV boluses was given at every 15-30th minute until the NRS ≤ 3.
Time frame: 24 hours
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Indonesia University