Effect of Quadratus Lumborum Block on Perioperative Analgesia and Inflammatory Responses in Laparoscopic Nephrectomy
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|ClinicalTrials.gov Identifier: NCT03879980|
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : March 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain||Drug: Bilateral QL block Drug: Non-QL block||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Forty-four healthy patients with American Society of Anesthesiologists (ASA) classification I or II gave written consent to participate and were randomly allocated into QL block group or control (non-QL block) group. Randomisation used blocks of 4 into 2 groups using a list of random numbers and was performed by sealed envelopes. The surgeries were performed by 3 urology surgeon consultants with comparable distributions. Patients and principal investigator were blinded to group allocation.|
|Primary Purpose:||Supportive Care|
|Official Title:||Effect of Preincisional Ultrasound-guided Quadratus Lumborum Block on Perioperative Analgesia and Inflammatory Responses in Transperitoneal Laparoscopic Nephrectomy: A Single-Blinded, Randomised Control Trial|
|Actual Study Start Date :||March 18, 2019|
|Estimated Primary Completion Date :||September 18, 2019|
|Estimated Study Completion Date :||October 1, 2019|
Placebo Comparator: Non-QL block
The control (non-QL block) group only received fentanyl IV during surgery.
Drug: Non-QL block
Only received fentanyl IV during surgery.
Experimental: Bilateral 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.
- Intraoperative fentanyl consumption [ Time Frame: Intraoperative ]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.
- Changes in Interleukin-6 from baseline [ Time Frame: 24 hours ]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.
- Numerical Rating Scale [ Time Frame: 24 hours ]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
- Hemodynamic Profiles: Heart Rate in bpm [ Time Frame: Intraoperative ]The trends of perioperative haemodynamic profiles during and after surgery: heart rate in beat per minute
- Hemodynamic Profiles: Systolic, Diastolic, and Mean Arterial Pressure in mmHg [ Time Frame: Intraoperative ]The trends of perioperative haemodynamic profiles during and after surgery : systolic, diastolic and mean arterial pressure in mmHg
- Number of participants with additional intravenous tramadol [ Time Frame: 24 hours ]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.
- Number of participants with additional intravenous fentanyl [ Time Frame: 24 hours ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03879980
|Contact: Dita Aditianingsih, M.D, PhDfirstname.lastname@example.org|
|Rumah Sakit Cipto Mangunkusumo||Recruiting|
|Jakarta Pusat, DKI Jakarta, Indonesia, 10430|
|Contact: Dita Aditianingsih, M.D., Ph.D +628151819244 email@example.com|
|Principal Investigator: Dita Aditianingsih, M.D.|