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Postoperative PainNCT03879980

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

A study testing Bilateral QL block and Non-QL block in people with Postoperative Pain, run by Universitas Indonesia at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Postoperative Pain
What is being tested?
Bilateral QL block and Non-QL block
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
44 participants
Where
1 siteIndonesia
Study dates
18 Mar 2019to 17 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • BMI < 30 kg/m2
  • ASA 1 or 2

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Rumah Sakit Cipto Mangunkusumo

    Jakarta Pusat, DKI Jakarta, 10430

Other trials in Indonesia

About this study

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

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.

Read the 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.

Being tested
Bilateral QL block, Non-QL block
Keywords
quadratus lumborum block, pre-emptive analgesia, laparoscopic nephrectomy
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bilateral QL blockDrug

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

  • Non-QL blockDrug

    Only received fentanyl IV during surgery.

Study groups in NCT03879980
Study groupRoleWhat they receive
Non-QL blockPlacebo comparatorThe control (non-QL block) group only received fentanyl IV during surgery.
Receives: Drug: Non-QL block
Bilateral QL blockExperimentalThe 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
Receives: Drug: Bilateral QL block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Intraoperative

  2. 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.

    Measured: 24 hours

Secondary outcomes (5)

  1. 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

    Measured: 24 hours

  2. Hemodynamic Profiles: Heart Rate in bpm

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

    Measured: Intraoperative

  3. 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

    Measured: Intraoperative

  4. 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.

    Measured: 24 hours

  5. 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.

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2019
  2. Study start18 Mar 2019
  3. Primary completion13 May 2019
  4. Study completion17 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03879980
Sponsor's protocol ID
IndonesiaUAnes031
Status last verified
Jul 2019
First submitted
12 Mar 2019
Last updated
10 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Hayden P, Cowman S. Anaesthesia for laparoscopic surgery. Continuing Education in Anaesthesia, Critical Care & Pain 2011;11(5):177-80.

  • Barreveld A, Witte J, Chahal H, Durieux ME, Strichartz G. Preventive analgesia by local anesthetics: the reduction of postoperative pain by peripheral nerve blocks and intravenous drugs. Anesth Analg. 2013 May;116(5):1141-1161. doi: 10.1213/ANE.0b013e318277a270. Epub 2013 Feb 13.

    PubMed 23408672

  • Richebe P, Rivat C, Liu SS. Perioperative or postoperative nerve block for preventive analgesia: should we care about the timing of our regional anesthesia? Anesth Analg. 2013 May;116(5):969-970. doi: 10.1213/ANE.0b013e31828843c9. No abstract available.

    PubMed 23606468

  • Meleine M, Rivat C, Laboureyras E, Cahana A, Richebe P. Sciatic nerve block fails in preventing the development of late stress-induced hyperalgesia when high-dose fentanyl is administered perioperatively in rats. Reg Anesth Pain Med. 2012 Jul-Aug;37(4):448-54. doi: 10.1097/AAP.0b013e318257a87a.

    PubMed 22660486

  • de Oliveira CM, Sakata RK, Issy AM, Gerola LR, Salomao R. Cytokines and pain. Rev Bras Anestesiol. 2011 Mar-Apr;61(2):255-9, 260-5, 137-42. doi: 10.1016/S0034-7094(11)70029-0. English, Portuguese, Spanish.

    PubMed 21474032

  • Vadivelu N, Mitra S, Schermer E, Kodumudi V, Kaye AD, Urman RD. Preventive analgesia for postoperative pain control: a broader concept. Local Reg Anesth. 2014 May 29;7:17-22. doi: 10.2147/LRA.S62160. eCollection 2014.

    PubMed 24872720

  • Krohg A, Ullensvang K, Rosseland LA, Langesaeter E, Sauter AR. The Analgesic Effect of Ultrasound-Guided Quadratus Lumborum Block After Cesarean Delivery: A Randomized Clinical Trial. Anesth Analg. 2018 Feb;126(2):559-565. doi: 10.1213/ANE.0000000000002648.

    PubMed 29135590

  • Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.

    PubMed 28154824

  • Warle MC, Berkers AW, Langenhuijsen JF, van der Jagt MF, Dooper PM, Kloke HJ, Pilzecker D, Renes SH, Wever KE, Hoitsma AJ, van der Vliet JA, D'Ancona FC. Low-pressure pneumoperitoneum during laparoscopic donor nephrectomy to optimize live donors' comfort. Clin Transplant. 2013 Jul-Aug;27(4):E478-83. doi: 10.1111/ctr.12143. Epub 2013 Jun 24.

    PubMed 23795745

  • Agarwal A, Yadav G, Gupta D, Singh PK, Singh U. Evaluation of intra-operative tramadol for prevention of catheter-related bladder discomfort: a prospective, randomized, double-blind study. Br J Anaesth. 2008 Oct;101(4):506-10. doi: 10.1093/bja/aen217. Epub 2008 Jul 24.

    PubMed 18653496

  • Moeller-Bertram T, Ky L, Coe C, Strigo I, Kincaid M, Keltner J, et al. Correlation of pain ratings and systemic interleukin-6 release in response to intramuscular capsaicin in healthy Humans. J Pain 2012;13(4):S52.

  • Blanco R. TAP block under ultrasound guidance: the description of a "no pops" technique [Abstract]. Reg Anesth Pain Med 2007;32:S1-S130.

  • Jianda X, Yuxing Q, Yi G, Hong Z, Libo P, Jianning Z. Impact of Preemptive Analgesia on inflammatory responses and Rehabilitation after Primary Total Knee Arthroplasty: A Controlled Clinical Study. Sci Rep. 2016 Aug 31;6:30354. doi: 10.1038/srep30354.

    PubMed 27578313

  • Farouk S. Pre-incisional epidural magnesium provides pre-emptive and preventive analgesia in patients undergoing abdominal hysterectomy. Br J Anaesth. 2008 Nov;101(5):694-9. doi: 10.1093/bja/aen274. Epub 2008 Sep 26.

    PubMed 18820247

Questions about this trial

What is this clinical trial studying?

A study testing Bilateral QL block and Non-QL block in people with Postoperative Pain, run by Universitas Indonesia at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intraoperative fentanyl consumption (time frame: Intraoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03879980, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.

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