Effect of Quadratus Lumborum Block on Perioperative Analgesia and Inflammatory Responses in Laparoscopic Nephrectomy

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Non-QL block; Drug: Bilateral QL block

• Registration Number: NCT03879980
• Lead Sponsor: Indonesia University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-03-12
• Study First Submitted QC: 2019-03-14
• Study Start: 2019-03-18
• Study First Posted: 2019-03-19
• Primary Completion: 2019-05-13
• Study Completion: 2019-06-17
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-09
• Last Update Posted: 2019-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• BMI < 30 kg/m2
• ASA 1 or 2

Exclusion Criteria

• refused to participate
• chronic use of analgesics or anti-inflammatory drugs
• allergy to local anaesthetic
• duration of surgery <4 or > 6 hours
• duration of anaesthesia <5 or > 7 hours
• neuropathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-QL block	Non-QL block	The control (non-QL block) group only received fentanyl IV during surgery.
Bilateral QL block	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

Primary Outcome Measures

Name	Time	Method
Intraoperative fentanyl consumption	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	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.

Secondary Outcome Measures

Name	Time	Method
Numerical Rating Scale	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	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	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	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	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.

Trial Locations

Locations (1)

Rumah Sakit Cipto Mangunkusumo; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia