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Postoperative PainNCT03771339

Comparison of Quadratus Lumborum Block and Epidural Analgesia Following Kidney Transplant Surgery

A study testing Continuous Epidural analgesia and Bilateral Quadratus Lumborum 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
Search all trials

Trial summary

Quadratus lumborum block as an alternative for postoperative analgesia compared with epidural block Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Postoperative Pain
What is being tested?
Continuous Epidural analgesia and Bilateral Quadratus Lumborum block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteIndonesia
Study dates
10 Dec 2018to 31 Jan 2020
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 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients undergoing elective kidney transplant laparotomy surgery
  • Agrees to participate in research
  • BMI < 30 kg/m2

Who cannot join

  • Declines to participate in research
  • Contraindications to intervention procedures (epidural or quadratus lumborum block)
  • History of local anaesthetic allergy
  • Systemic allergic reactions, anaphylactic reaction, cardiac arrest
  • Failure of intervention procedures (epidural or quadratus lumborum block)
  • Intraoperative complications (massive bleeding, hypotension)

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: Comparison of Ultrasound-Guided Quadratus Lumborum Block and Epidural Analgesia for Postoperative Pain Management After Renal Transplantation

Quadratus lumborum block as an alternative for postoperative analgesia compared with epidural block

Read the detailed description

Epidural analgesia is the main choice of analgesia following kidney transplant surgery. However, continuous epidural technique had some concerning side effects such as hemodynamic instabilities, urine retention, motor/sensory disturbances/weakness, and mobilisation comfort, it could also cause hypotension which could affect graft success. Quadratus lumborum (QL) block had lesser side effects thus could be an option for postoperative analgesia, however there are no study showing the safety and success rate of QL block techniques for patients who underwent kidney transplant surgery.

Being tested
Continuous Epidural analgesia, Bilateral Quadratus Lumborum block
Keywords
quadratus lumborum block, continuous epidural, postoperative analgesia, kidney transplant
Medical subject headings
Pain, Postoperative

What participants receive

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

  • Continuous Epidural analgesiaProcedure or surgery

    Continuous Epidural catheter is inserted at the Thoracic 11-T12 level, using Ropivacaine 0.375% 3 mL bolus followed by Ropivacaine 0.2% with rate 6 mL/hour for 24 hours after laparoscopic nephrectomy

  • Bilateral Quadratus Lumborum blockProcedure or surgery

    Bilateral anterior Quadratus Lumborum block using Ropivacaine 0.375% 20 mL each injection as postoperative analgesia treatment for 24 hours

Study groups in NCT03771339
Study groupRoleWhat they receive
Continuous Epidural AnalgesiaActive comparatorContinuous epidural analgesia using ropivacaine 0.375% 3 mL boluses followed by ropivacaine 0.2% with rate 6 mL per hour for 24 hours
Receives: Procedure: Continuous Epidural analgesia
Bilateral Quadratus Lumborum BlockExperimentalBilateral Quadratus lumborum block using ropivacaine 0.2% 20 mL each injection after surgery
Receives: Procedure: Bilateral Quadratus Lumborum block

What is being measured

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

  1. Morphine consumption

    Additional analgesia required at 2, 6, 12, and 24 hours after surgery

    Measured: 24 hours

Secondary outcomes (8)

  1. Pain Intensity

    Pain intensity measured using the Visual Analogue Scale (VAS) at 2, 6, 12, and 24 hours after surgery. VAS assessed with horizontal line 0-100 mm for no pain to the worst pain, with range 0-30 mm for none to mild pain, 31-70 mm for moderate pain, 71-100 mm for severe pain.

    Measured: 24 hours

  2. First time morphine required

    Total time gap from postoperative analgesia procedure administration to first morphine requirement

    Measured: 24 hours

  3. Total minimum and maximum dose of vasoactive agents

    Minimum and maximum dose of norepinephrine and dobutamine as vasoactive agents within 24 hours after surgery

    Measured: 24 hours

  4. Urine output

    Urine output (mL/kgBW/hour) after surgery

    Measured: 24 hours

  5. Bromage score

    Bromage score at 2, 6, 12, and 24 hours after surgery to assess lower limb motoric block.

    Score for Bromage:

    1. free movement
    2. partial block
    3. almost complete
    4. complete block

    Measured: 24 hours

  6. Ramsay score

    Ramsay score at 2, 6, 12, and 24 hours after surgery to assess patient sedation level.

    Measured: 24 hours

  7. Dermatomal coverage of analgesia procedure

    dermatome sensory block distribution using cold sensation test

    Measured: Immediately after anaesthesia completion

  8. Blood ropivacaine level

    Arterial blood sample of all subjects will be withdrawn approximately 3 mL from the arterial line at 0, 30, 45, 60 minute, and 2, 4, 6,12,18, 24 hours after designated analgesia procedure, and will be used for ropivacaine blood level measurements using High-Performance Liquid Chromatography (HPLC), to measure Total plasma ropivacaine concentration (Cstop), maximum plasma concentration (Cmax), time of maximum plasma concentration, area under the curve (AUC)

    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 posted11 Dec 2018
  2. Study start10 Dec 2018
  3. Primary completion31 Jan 2020
  4. Study completion31 Jan 2020

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03771339
Sponsor's protocol ID
IndonesiaUAnes030
Status last verified
Oct 2020
First submitted
6 Dec 2018
Last updated
28 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Mochtar CA, Alfarissi F, Soeroto AA, Hamid ARAH, Wahyudi I, Marbun MBH, et al. Milestones of kidney transplantation in Indonesia. Med J Indones. 2017 Nov 27;26(3):229.

  • Kakaei F, Nikeghbalian S, Ali S. Kidney Transplantation Techniques. In: Rath T, editor. Current Issues and Future Direction in Kidney Transplantation [Internet]. InTech; 2013 [cited 2018 Jun 6]. Available from: http://www.intechopen.com/books/current-issues-and-future-direction-in-kidney-transplantation/kidney-transplantation-techniques

  • Pham PC, Khaing K, Sievers TM, Pham PM, Miller JM, Pham SV, Pham PA, Pham PT. 2017 update on pain management in patients with chronic kidney disease. Clin Kidney J. 2017 Oct;10(5):688-697. doi: 10.1093/ckj/sfx080. Epub 2017 Aug 18.

    PubMed 28979781

  • Abdelsalam K., Sultan S. Effectiveness of ultrasound-guided transversus abdominis plane block for intraoperative and postoperative analgesia in kidney transplantation. Ain-Shams J Anaesthesiol. 2015;8(1):140.

  • Srivastava D, Tiwari T, Sahu S, Chandra A, Dhiraaj S. Anaesthetic management of renal transplant surgery in patients of dilated cardiomyopathy with ejection fraction less than 40%. Anesthesiol Res Pract. 2014;2014:525969. doi: 10.1155/2014/525969. Epub 2014 Aug 19.

    PubMed 25210514

  • S Martinez B. Anesthesia for Kidney Transplantation-A Review. J Anesth Clin Res [Internet]. 2013 [cited 2018 Jun 6];04(01). Available from: https://www.omicsonline.org/anesthesia-for-kidney-transplantation-a-review-2155-6148.1000270.php?aid=11555

  • Hirata ES, Baghin MF, Pereira RI, Alves Filho G, Udelsmann A. Influence of the anesthetic technique on the hemodynamic changes in renal transplantation: a retrospective study. Rev Bras Anestesiol. 2009 Mar-Apr;59(2):166-76. doi: 10.1590/s0034-70942009000200004. English, Portuguese.

    PubMed 19488528

  • Aulakh NK, Garg K, Bose A, Aulakh BS, Chahal HS, Aulakh GS. Influence of hemodynamics and intra-operative hydration on biochemical outcome of renal transplant recipients. J Anaesthesiol Clin Pharmacol. 2015 Apr-Jun;31(2):174-9. doi: 10.4103/0970-9185.155144.

    PubMed 25948896

  • 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

  • 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

  • Mieszkowski MM, Mayzner-Zawadzka E, Tuyakov B, Mieszkowska M, Zukowski M, Wasniewski T, Onichimowski D. Evaluation of the effectiveness of the Quadratus Lumborum Block type I using ropivacaine in postoperative analgesia after a cesarean section - a controlled clinical study. Ginekol Pol. 2018;89(2):89-96. doi: 10.5603/GP.a2018.0015.

    PubMed 29512813

  • Lemmens HJ. Kidney transplantation: recent developments and recommendations for anesthetic management. Anesthesiol Clin North Am. 2004 Dec;22(4):651-62. doi: 10.1016/j.atc.2004.05.007.

    PubMed 15541928

  • Hockett MM, Hembrador S, Lee A. Continuous Quadratus Lumborum Block for Postoperative Pain in Total Hip Arthroplasty: A Case Report. A A Case Rep. 2016 Sep 15;7(6):129-31. doi: 10.1213/XAA.0000000000000363.

    PubMed 27513972

  • Mukhtar K, Khattak I. Transversus abdominis plane block for renal transplant recipients. Br J Anaesth. 2010 May;104(5):663-4. doi: 10.1093/bja/aeq077. No abstract available.

    PubMed 20400617

  • Tsai HC, Yoshida T, Chuang TY, Yang SF, Chang CC, Yao HY, Tai YT, Lin JA, Chen KY. Transversus Abdominis Plane Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:8284363. doi: 10.1155/2017/8284363. Epub 2017 Oct 31.

    PubMed 29226150

Questions about this trial

What is this clinical trial studying?

A study testing Continuous Epidural analgesia and Bilateral Quadratus Lumborum 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 3 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 28 Oct 2020. 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. 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?

Morphine consumption (time frame: 24 hours). 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 NCT03771339, which also lists 32 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 28 Oct 2020.

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