Ultrasound Guided Continuous Quadratus Lumborum Block Versus Continuous Paravertebral Block In Radical Cystectomy

NCT03547011 | Completed

• 1 other identifier: 050108380 (13/6/2017)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study to compare between intraoperative and postoperative analgesic effect of ultrasound guided continuous quadratus lumborum block and continuous thoracic paravertebral block in patients operated for radical cystectomy (primary outcome). Side effects, length of hospital stay and patient satisfaction(secondary outcome).

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• analgesic effect

  Visual Analogue Scale measure and needed postoperative analgesics.0 to 10, as 0 no pain 10 the worst pain.

  72 hours

Secondary Outcomes (3)

• Side effects

  30 days

• length of hospital stay

  30 days

• Patient satisfaction.

  30 days

Study Arms (2)

US guided Quadratus Lumborum block

ACTIVE COMPARATOR

Patients will receive ultrasound guided quadratus lumborum block with 0.3 ml /kg bupivacaine 0.25% on each side with catheter insertion for maintenance doses 0.1ml/kg/hr on each side.

Procedure: US guided Quadratus Lumborum block

US guided Paravertebral block.

ACTIVE COMPARATOR

Patients will receive ultrasound guided thoracic paravertebral block with 0.3 ml/kg bupivacaine 0.25 % on each side with catheter insertion for maintenance doses 0.1 ml/kg/hr on each side.

Procedure: US guided Paravertebral block.

Interventions

US guided Quadratus Lumborum block PROCEDURE

Patients will receive ultrasound guided quadratus lumborum block with 0.3 ml /kg bupivacaine 0.25% on each side with catheter insertion for maintenance doses 0.1ml/kg/hr on each side.

US guided Quadratus Lumborum block

US guided Paravertebral block. PROCEDURE

Patients will receive ultrasound guided thoracic paravertebral block with 0.3 ml/kg bupivacaine 0.25 % on each side with catheter insertion for maintenance doses 0.1 ml/kg/hr on each side.

US guided Paravertebral block.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• After written informed consent from each patient or oral consent if illiteracy prevent a written consent, The present study will be carried out in the Urosurgery department at Alexandria Main University hospital on 60 adult patients scheduled for radical cystectomy, males and females.
• Patients will be randomly assigned into two equal groups (30 patients each) according to type of the block:
• Group I:
• Patients will receive ultrasound guided quadratus lumborum block with 0.3 ml /kg bupivacaine 0.25% on each side with catheter insertion for maintenance doses 0.1ml/kg/hr on each side.
• Group II:
• Patients will receive ultrasound guided thoracic paravertebral block with 0.3 ml/kg bupivacaine 0.25 % on each side with catheter insertion for maintenance doses 0.1 ml/kg/hr on each side.

You may not qualify if:

• Patient refusal.
• Coagulopathy/ thrombocytopenia.
• Localized infection at the proposed site of injection.
• Inability to comprehend the scoring systems to be employed due to mental problems.
• known allergy to the drugs to be used (local anesthetics, opioids)
• Opioid tolerance/ dependence
• Back abnormalities.
• Neurological deficits.

Sponsors & Collaborators

• University of Alexandria: lead

Study Sites (1)

Alexandria Faculty of Medicine

Alexandria, 21111, Egypt

Location

Related Publications (12)

• Arumainayagam N, McGrath J, Jefferson KP, Gillatt DA. Introduction of an enhanced recovery protocol for radical cystectomy. BJU Int. 2008 Mar;101(6):698-701. doi: 10.1111/j.1464-410X.2007.07319.x. Epub 2008 Jan 8.

  PMID: 18190646 BACKGROUND

• Novotny V, Hakenberg OW, Wiessner D, Heberling U, Litz RJ, Oehlschlaeger S, Wirth MP. Perioperative complications of radical cystectomy in a contemporary series. Eur Urol. 2007 Feb;51(2):397-401; discussion 401-2. doi: 10.1016/j.eururo.2006.06.014. Epub 2006 Jun 27.

  PMID: 16905242 BACKGROUND

• Bulka CM, Shotwell MS, Gupta RK, Sandberg WS, Ehrenfeld JM. Regional anesthesia, time to hospital discharge, and in-hospital mortality: a propensity score matched analysis. Reg Anesth Pain Med. 2014 Sep-Oct;39(5):381-6. doi: 10.1097/AAP.0000000000000121.

  PMID: 25025697 BACKGROUND

• Liu SS, Wu CL. Effect of postoperative analgesia on major postoperative complications: a systematic update of the evidence. Anesth Analg. 2007 Mar;104(3):689-702. doi: 10.1213/01.ane.0000255040.71600.41.

  PMID: 17312231 BACKGROUND

• Niraj G, Kelkar A, Jeyapalan I, Graff-Baker P, Williams O, Darbar A, Maheshwaran A, Powell R. Comparison of analgesic efficacy of subcostal transversus abdominis plane blocks with epidural analgesia following upper abdominal surgery. Anaesthesia. 2011 Jun;66(6):465-71. doi: 10.1111/j.1365-2044.2011.06700.x. Epub 2011 Apr 4.

  PMID: 21457153 BACKGROUND

• Murouchi T, Iwasaki S, Yamakage M. Quadratus Lumborum Block: Analgesic Effects and Chronological Ropivacaine Concentrations After Laparoscopic Surgery. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):146-50. doi: 10.1097/AAP.0000000000000349.

  PMID: 26735154 BACKGROUND

• Naja Z, Ziade MF, Lonnqvist PA. Bilateral paravertebral somatic nerve block for ventral hernia repair. Eur J Anaesthesiol. 2002 Mar;19(3):197-202. doi: 10.1017/s0265021502000352.

  PMID: 12071240 BACKGROUND

• Richardson J, Vowden P, Sabanathan S. Bilateral paravertebral analgesia for major abdominal vascular surgery: a preliminary report. Anaesthesia. 1995 Nov;50(11):995-8. doi: 10.1111/j.1365-2044.1995.tb05939.x.

  PMID: 8678263 BACKGROUND

• Exadaktylos AK, Buggy DJ, Moriarty DC, Mascha E, Sessler DI. Can anesthetic technique for primary breast cancer surgery affect recurrence or metastasis? Anesthesiology. 2006 Oct;105(4):660-4. doi: 10.1097/00000542-200610000-00008.

  PMID: 17006061 BACKGROUND

• Visoiu M, Yakovleva N. Continuous postoperative analgesia via quadratus lumborum block - an alternative to transversus abdominis plane block. Paediatr Anaesth. 2013 Oct;23(10):959-61. doi: 10.1111/pan.12240. Epub 2013 Aug 9.

  PMID: 23927552 BACKGROUND

• Bouzinac A, Delbos A, Mazieres M, Rontes O. [Ultrasound-guided bilateral paravertebral thoracic block in an obese patient]. Ann Fr Anesth Reanim. 2011 Feb;30(2):162-3. doi: 10.1016/j.annfar.2010.11.021. Epub 2011 Feb 1. No abstract available. French.

  PMID: 21282032 BACKGROUND

• Aitken RC. Measurement of feelings using visual analogue scales. Proc R Soc Med. 1969 Oct;62(10):989-93. doi: 10.1177/003591576906201005. No abstract available.

  PMID: 4899510 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Mohammad Hazem I Ahmad Sabry, MB,ChB MD

  Alexandria Univeristy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The patients, outcome assessors and care providers are not informed with the block type done.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia

Model Details: Double blinded randomized study.

Study Record Dates

• First Submitted: December 3, 2017
• First Posted: June 6, 2018
• Study Start: September 16, 2017
• Primary Completion: June 30, 2018
• Study Completion: July 3, 2018
• Last Updated: January 15, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Before the start till publishing the study.
• Access Criteria: not public only the researchers who can access the study information.

Locations

EG (1)