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

Primary Purpose

Postoperative Pain

Status

Completed

Phase

Not Applicable

Locations

Indonesia

Study Type

Interventional

Intervention

Bilateral QL block

Non-QL block

About this trial

This is an interventional supportive care trial for Postoperative Pain focused on measuring quadratus lumborum block, pre-emptive analgesia, laparoscopic nephrectomy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Rumah Sakit Cipto Mangunkusumo

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Non-QL block

Bilateral QL block

Arm Description

The control (non-QL block) group only received fentanyl IV during surgery.

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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

Hemodynamic Profiles: Heart Rate in bpm

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

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

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

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.

Full Information

NCT ID

NCT03879980

First Posted

March 12, 2019

Last Updated

July 9, 2019

Sponsor

Indonesia University

1. Study Identification

Unique Protocol Identification Number

NCT03879980

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

March 18, 2019 (Actual)

Primary Completion Date

May 13, 2019 (Actual)

Study Completion Date

June 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

Keywords

quadratus lumborum block, pre-emptive analgesia, laparoscopic nephrectomy

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

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.

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Non-QL block

Arm Type

Placebo Comparator

Arm Description

The control (non-QL block) group only received fentanyl IV during surgery.

Arm Title

Bilateral QL block

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Bilateral QL block

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Non-QL block

Intervention Description

Only received fentanyl IV during surgery.

Primary Outcome Measure Information:

Title

Intraoperative fentanyl consumption

Description

Time Frame

Intraoperative

Title

Changes in Interleukin-6 from baseline

Description

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Numerical Rating Scale

Description

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

Title

Hemodynamic Profiles: Heart Rate in bpm

Description

The trends of perioperative haemodynamic profiles during and after surgery: heart rate in beat per minute

Time Frame

Intraoperative

Title

Hemodynamic Profiles: Systolic, Diastolic, and Mean Arterial Pressure in mmHg

Description

The trends of perioperative haemodynamic profiles during and after surgery : systolic, diastolic and mean arterial pressure in mmHg

Time Frame

Intraoperative

Title

Number of participants with additional intravenous tramadol

Description

Time Frame

24 hours

Title

Number of participants with additional intravenous fentanyl

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Rumah Sakit Cipto Mangunkusumo

City

Jakarta Pusat

State/Province

DKI Jakarta

ZIP/Postal Code

10430

Country

Indonesia

12. IPD Sharing Statement

Citations:

Citation

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Results Reference

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PubMed Identifier

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Citation

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Citation

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

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