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OpenTrials
Completed

NCT Number: NCT03879980

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

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rumah Sakit Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bilateral QL block

Drug

Bilateral lateral Quadratus Lumborum block using 20 ml of 0.25% bupivacaine each injection as preemptive analgesia.

Non-QL block

Drug

Only received fentanyl IV during surgery.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 19, 2019
Registry last updated
Jul 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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