Pain, PostoperativeNCT03547011
Ultrasound Guided Continuous Quadratus Lumborum Block Versus Continuous Paravertebral Block In Radical Cystectomy
A study testing US guided Quadratus Lumborum block and US guided Paravertebral block. in people with Pain, Postoperative, run by University of Alexandria at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- US guided Quadratus Lumborum block and US guided Paravertebral block.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Sep 2017to 3 Jul 2018
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Ultrasound Guided Continuous Quadratus Lumborum Block Versus Continuous Paravertebral Block In Radical Cystectomy
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).
Read the detailed description
The analgesic efficacy of ultrasound guided continuous quadratus lumborum block versus continuous paravertebral block in radical cystectomy
Protocol of a thesis submitted to the Faculty of Medicine University of Alexandria In partial fulfillment of the requirements of the degree of Master of Anaesthesia And Surgical Intensive Care
By
Amr Ragheb Hieba MBBCh, Alex. Resident Alexandria University Hospitals Department of Anaesthesia and Surgical Intensive Care Faculty of Medicine University of Alexandria 2017
SUPERVISORS
Prof. Dr. Ramadan Abdelazeem Ammar Professor of Anaesthesia and Surgical Intensive care, Faculty of Medicine University of Alexandria
CO-SUPERVISOR
Dr.Mohamad Hazem Ibrahim Ahmed Sabry
Lecturer in Anaesthesia and Surgical Intensive Care, Faculty of Medicine, University of Alexandria. For his experience in regional anaesthesia.
INTRODUCTION Bladder cancer is the most common malignancy of the urinary tract and radical cystectomy remains the gold standard for management of muscle invasive disease.(1) Despite improvement in perioperative period it remains associated with a greater morbidity and more prolonged inpatient stay than other urological studies. Bowel complications particularly ileus are amongst the commonest problems that patients experience.)2,3) Pain is common after major abdominal surgeries.Uncontrolled postoperative pain increases the incidence of postoperative complications.Multimodal analgesia can improve pain control in postoperative period and reduces complications that may arise from using a single mode of analgesia.(4) Effective regional anesthesia techniques for abdominal surgery include epidural,paravertebral , transverses abdominis plane (TAP) block .multiple approaches have been used for TAP block with ultrasound guided midaxillary approach but are sometimes patchy with variable wound coverage . the use of ultrasound approach at the level of quadratus lumborum muscle is new and may provide wider spread of the local anesthetic ( T5-L1) than TAP and paravertebral blocks.(5) Studies of quadratus lumborum block show its use in postoperative analgesia in major abdominal surgery. Results have shown widespread and long-lasting analgesic effect after ovarian surgery and resulted in lower peak arterial concentrations of injected bupivacaine as compared to lateral TAPB.(6)
Similarly, thoracic paravertebral block (PVB) has been demonstrated to provide effective postoperative analgesia in patients undergoing minor and major abdominal surgery by blocking sensory innervations of the abdominal wall. PVB significantly reduces the need for supplemental opioid administration, reduces postoperative nausea and vomiting (PONV), and in some patient groups shortens length of hospital stay. Although PVB has been demonstrated to be effective in patients undergoing abdominal and thoracic surgery, its analgesic efficacy after major gynecological surgery has not, as yet, been reported .(7,8) Studies have shown that regional anesthetic technique for cancer surgery could affect recurrence or metastasis. This retrospective study suggests that paravertebral anaesthesia and analgesia for breast cancer surgery reduces the risk of recurrence or metastasis during the initial years of follow up. (9)
AIM OF THE WORK 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).
PATIENTS
- After approval of Local Ethics Committee, and 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.
Exclusion Criteria:
- 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
METHODS
Pre-operative assessment and preparation:
- History taking ,
- Clinical examination ,
- All needed laboratory investigations. The technique ofanaesthesiawill be explained to patients.
Premedication:
All patients will be premedicated with midazolam 0.05 mg/kg IV 30 min before surgery.
Anaesthetic technique:
A multichannel monitor will be connected to the patient to display continuous electrocardiography monitoring for heart rate (beat/min) and detection of dysrhythmias, noninvasive arterial blood pressure (mmHg), respiratory rate and arterial oxygen saturation (SpO2) .
Baseline monitoring data (blood pressure, heart rate, respiratory rate and oxygen saturation) will be recorded.
Induction of anaesthesia will be carried out with fentanyl citrate (1µ/kg)i.v, propofol 2mg/kg i.v will be injected till loss of verbal communication and endotracheal intubation will be facilitated by rocuronium bromide 0.6mg/kg.
Ventilation will be maintained with Drager fabius plus ventilator as IPPV volume control.
Anaesthesia will be maintained with Isoflurane in 100% oxygen, intermittent boluses of Rocuroniun (0.1mg/kg).
Technique of QL block group After induction of general anesthesia,the patient will be positioned for lateral position to obtain appropriate view of QL and thoracic PV block.Aseptic measures will be taken by wearing sterile gown and sterile drapes .Ultrasound will be used with linear probe covered with sterile elastic sheath. Probe will be placed horizontally between the costal margin and iliac crest. The 3 muscle layer of the abdominal wall will be identified as external oblique, internal oblique , transverses abdominis muscles .The fascia surrounding transverses abdominis will be tracked until its origin, where transverses abdominis muscle merge with thoracolumbar fascia surrounding quadratus lumborum muscle .
18 G 3 inch long non stimulating echoic needle will be inserted in plane with the ultrasound probe and targeted toward fascia transversalis . Normal saline 3 ml will be used to identify the splitting of the fascia .Then injection of 0.3 ml/kg bupivacaine 0.25% in the same plane after negative aspiration.
This will be seen spreading around quadratus lumborum muscle. Echogenic catheter will be advanced 7 cm beyond the tip of the needle with minimal resistance.(10) Maintenance will be 0.1 ml\kg\hr. The procedure will be repeated on the other side after placing the patient in the opposite position.
Technique for thoracic paravertebral block After general anesthesia, the patient will be positioned to lateral position. Under strict aseptic technique, Ultrasound will be used with linear probe covered with sterile elastic sheath .Probe is applied longitudinal at level of T10.
For most of patients, the depth of field is set to 3 cm to start scanning. The transverse processes and ribs are shown as hyperechoic structures with acoustic shadowing between them.
Once the transverse processes and ribs are identified, the transducer is moved slightly cauded into the intercostals space between adjacent ribs to identify the thoracic PVS and adjoining intercostal space.
The PVS appears as a wedge shaped hypoechoic layer demarcated by the hyperechoic reflections of the pleura below and internal intercostal membrane above.
The hyperechoic line of the pleura and underlying hyperechoic air artifacts move with respiration .the goal of the technique is to insert the needle into PVS to inject 0.3ml∕kg bupivacaine 0.25% .(11) Echogenic catheter is advanced 7 cm beyond the tip of the needle with minimal resistance.
Maintenance will be 0.1ml\kg\hr. The same procedure will be repeated on the other side after placing the patient in the opposite position .
Measurements
The following parameters will be measured :
A- Hemodynamic parameters :
- Heart rate (beat per minute )
- Mean arterial blood pressure (mmHg)
- Oxygen saturation using pulse oximetry . All previous parameters will be continuously monitored and recorded at the following periods : preoperative , every 30 minutes intraoperative till the end of surgery and every 12 hrs postoperative for 3 days .
B - Intensity of postoperative pain :
Patients will be asked to quantify their pain on a visual analogue scale between 0 - 10 with (0) representing no pain and ( 10 ) representing the worst imaginable pain .(12)
It will be measured postoperative every 12hrs for 3 days .
C - Analgesic requirements :
- First request of analgesia .
- Rescue analgesia in the form of nalbuphine 0.1 mg / kg will be given when VAS score ≥4 . VAS to be assessed every 12 hrs and give rescue analgesia accordingly .
- Total dose of analgesia given .
ETHICS OF RESEARCH
Research on human or human products:
Prospective study: Informed consent will be taken from patients. In case of incompetent patients the informed consent will be taken from the guardians.
All drugs used in the research are approved by the Egyptian Ministry of Health
RESULTS Results will be put in tables. Appropriate statistical analysis test will be done.
DISCUSSION The results of the study will be discussed in view of achievement of the aim and will be compared to the other studies.
- Conditions
- Pain, Postoperative
- Being tested
- US guided Quadratus Lumborum block, US guided Paravertebral block.
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US guided Quadratus Lumborum blockProcedure or surgery
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 Paravertebral block.Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: US guided Paravertebral block. |
What is being measured
The primary outcome is the main question the study is designed to answer.
analgesic effect
Visual Analogue Scale measure and needed postoperative analgesics.0 to 10, as 0 no pain 10 the worst pain.
Measured: 72 hours
Secondary outcomes (3)
Side effects
numbers of side effects
Measured: 30 days
length of hospital stay
Number of days in hospitals
Measured: 30 days
Patient satisfaction.
Numbers from 0-10
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start16 Sep 2017
- Primary completion30 Jun 2018
- Study completion3 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Double blinded randomized study.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alexandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Hazem I. Ahmad Sabry, University of Alexandria
- Investigators
- Mohammad Hazem I Ahmad Sabry, MB,ChB MD, Principal investigator, Alexandria Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03547011
- Sponsor's protocol ID
- 050108380 (13/6/2017)
- Status last verified
- Jan 2019
- First submitted
- 3 Dec 2017
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data results and statistical analysis.
Publications
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.
PubMed 18190646Novotny 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.
PubMed 16905242Bulka 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.
PubMed 25025697Liu 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.
PubMed 17312231Niraj 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.
PubMed 21457153Murouchi 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.
PubMed 26735154Naja 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.
PubMed 12071240Richardson 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.
PubMed 8678263Exadaktylos 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.
PubMed 17006061Visoiu 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.
PubMed 23927552Bouzinac 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.
PubMed 21282032Aitken 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.
PubMed 4899510
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Ultrasound Guided Continuous Quadratus Lumborum Block Versus Continuous Paravertebral Block In Radical Cystectomy
- ClinicalTrials.gov ID
- NCT03547011
- Acronym / sponsor ID
- 050108380 (13/6/2017)
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of AlexandriaUniversity, hospital or other
- Study start
- 16 Sep 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 3 Jul 2018 (actual)
- First posted
- 6 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The analgesic efficacy of ultrasound guided continuous quadratus lumborum block versus continuous paravertebral block in radical cystectomy
Protocol of a thesis submitted to the Faculty of Medicine University of Alexandria In partial fulfillment of the requirements of the degree of Master of Anaesthesia And Surgical Intensive Care
By
Amr Ragheb Hieba MBBCh, Alex. Resident Alexandria University Hospitals Department of Anaesthesia and Surgical Intensive Care Faculty of Medicine University of Alexandria 2017
SUPERVISORS
Prof. Dr. Ramadan Abdelazeem Ammar Professor of Anaesthesia and Surgical Intensive care, Faculty of Medicine University of Alexandria
CO-SUPERVISOR
Dr.Mohamad Hazem Ibrahim Ahmed Sabry
Lecturer in Anaesthesia and Surgical Intensive Care, Faculty of Medicine, University of Alexandria. For his experience in regional anaesthesia.
INTRODUCTION Bladder cancer is the most common malignancy of the urinary tract and radical cystectomy remains the gold standard for management of muscle invasive disease.(1) Despite improvement in perioperative period it remains associated with a greater morbidity and more prolonged inpatient stay than other urological studies. Bowel complications particularly ileus are amongst the commonest problems that patients experience.)2,3) Pain is common after major abdominal surgeries.Uncontrolled postoperative pain increases the incidence of postoperative complications.Multimodal analgesia can improve pain control in postoperative period and reduces complications that may arise from using a single mode of analgesia.(4) Effective regional anesthesia techniques for abdominal surgery include epidural,paravertebral , transverses abdominis plane (TAP) block .multiple approaches have been used for TAP block with ultrasound guided midaxillary approach but are sometimes patchy with variable wound coverage . the use of ultrasound approach at the level of quadratus lumborum muscle is new and may provide wider spread of the local anesthetic ( T5-L1) than TAP and paravertebral blocks.(5) Studies of quadratus lumborum block show its use in postoperative analgesia in major abdominal surgery. Results have shown widespread and long-lasting analgesic effect after ovarian surgery and resulted in lower peak arterial concentrations of injected bupivacaine as compared to lateral TAPB.(6)
Similarly, thoracic paravertebral block (PVB) has been demonstrated to provide effective postoperative analgesia in patients undergoing minor and major abdominal surgery by blocking sensory innervations of the abdominal wall. PVB significantly reduces the need for supplemental opioid administration, reduces postoperative nausea and vomiting (PONV), and in some patient groups shortens length of hospital stay. Although PVB has been demonstrated to be effective in patients undergoing abdominal and thoracic surgery, its analgesic efficacy after major gynecological surgery has not, as yet, been reported .(7,8) Studies have shown that regional anesthetic technique for cancer surgery could affect recurrence or metastasis. This retrospective study suggests that paravertebral anaesthesia and analgesia for breast cancer surgery reduces the risk of recurrence or metastasis during the initial years of follow up. (9)
AIM OF THE WORK 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).
PATIENTS
- After approval of Local Ethics Committee, and 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.
Exclusion Criteria:
- 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
METHODS
Pre-operative assessment and preparation:
- History taking ,
- Clinical examination ,
- All needed laboratory investigations. The technique ofanaesthesiawill be explained to patients.
Premedication:
All patients will be premedicated with midazolam 0.05 mg/kg IV 30 min before surgery.
Anaesthetic technique:
A multichannel monitor will be connected to the patient to display continuous electrocardiography monitoring for heart rate (beat/min) and detection of dysrhythmias, noninvasive arterial blood pressure (mmHg), respiratory rate and arterial oxygen saturation (SpO2) .
Baseline monitoring data (blood pressure, heart rate, respiratory rate and oxygen saturation) will be recorded.
Induction of anaesthesia will be carried out with fentanyl citrate (1µ/kg)i.v, propofol 2mg/kg i.v will be injected till loss of verbal communication and endotracheal intubation will be facilitated by rocuronium bromide 0.6mg/kg.
Ventilation will be maintained with Drager fabius plus ventilator as IPPV volume control.
Anaesthesia will be maintained with Isoflurane in 100% oxygen, intermittent boluses of Rocuroniun (0.1mg/kg).
Technique of QL block group After induction of general anesthesia,the patient will be positioned for lateral position to obtain appropriate view of QL and thoracic PV block.Aseptic measures will be taken by wearing sterile gown and sterile drapes .Ultrasound will be used with linear probe covered with sterile elastic sheath. Probe will be placed horizontally between the costal margin and iliac crest. The 3 muscle layer of the abdominal wall will be identified as external oblique, internal oblique , transverses abdominis muscles .The fascia surrounding transverses abdominis will be tracked until its origin, where transverses abdominis muscle merge with thoracolumbar fascia surrounding quadratus lumborum muscle .
18 G 3 inch long non stimulating echoic needle will be inserted in plane with the ultrasound probe and targeted toward fascia transversalis . Normal saline 3 ml will be used to identify the splitting of the fascia .Then injection of 0.3 ml/kg bupivacaine 0.25% in the same plane after negative aspiration.
This will be seen spreading around quadratus lumborum muscle. Echogenic catheter will be advanced 7 cm beyond the tip of the needle with minimal resistance.(10) Maintenance will be 0.1 ml\kg\hr. The procedure will be repeated on the other side after placing the patient in the opposite position.
Technique for thoracic paravertebral block After general anesthesia, the patient will be positioned to lateral position. Under strict aseptic technique, Ultrasound will be used with linear probe covered with sterile elastic sheath .Probe is applied longitudinal at level of T10.
For most of patients, the depth of field is set to 3 cm to start scanning. The transverse processes and ribs are shown as hyperechoic structures with acoustic shadowing between them.
Once the transverse processes and ribs are identified, the transducer is moved slightly cauded into the intercostals space between adjacent ribs to identify the thoracic PVS and adjoining intercostal space.
The PVS appears as a wedge shaped hypoechoic layer demarcated by the hyperechoic reflections of the pleura below and internal intercostal membrane above.
The hyperechoic line of the pleura and underlying hyperechoic air artifacts move with respiration .the goal of the technique is to insert the needle into PVS to inject 0.3ml∕kg bupivacaine 0.25% .(11) Echogenic catheter is advanced 7 cm beyond the tip of the needle with minimal resistance.
Maintenance will be 0.1ml\kg\hr. The same procedure will be repeated on the other side after placing the patient in the opposite position .
Measurements
The following parameters will be measured :
A- Hemodynamic parameters :
- Heart rate (beat per minute )
- Mean arterial blood pressure (mmHg)
- Oxygen saturation using pulse oximetry . All previous parameters will be continuously monitored and recorded at the following periods : preoperative , every 30 minutes intraoperative till the end of surgery and every 12 hrs postoperative for 3 days .
B - Intensity of postoperative pain :
Patients will be asked to quantify their pain on a visual analogue scale between 0 - 10 with (0) representing no pain and ( 10 ) representing the worst imaginable pain .(12)
It will be measured postoperative every 12hrs for 3 days .
C - Analgesic requirements :
- First request of analgesia .
- Rescue analgesia in the form of nalbuphine 0.1 mg / kg will be given when VAS score ≥4 . VAS to be assessed every 12 hrs and give rescue analgesia accordingly .
- Total dose of analgesia given .
ETHICS OF RESEARCH
Research on human or human products:
Prospective study: Informed consent will be taken from patients. In case of incompetent patients the informed consent will be taken from the guardians.
All drugs used in the research are approved by the Egyptian Ministry of Health
RESULTS Results will be put in tables. Appropriate statistical analysis test will be done.
DISCUSSION The results of the study will be discussed in view of achievement of the aim and will be compared to the other studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blinded randomized study.
| Arm | Type | Receives |
|---|---|---|
| US guided Quadratus Lumborum block | Active comparator | Procedure: US guided Quadratus Lumborum blockPatients 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 Paravertebral block. | Active comparator | Procedure: US guided Paravertebral block.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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- • 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 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.
- 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.
Key exclusion criteria (8 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| US guided Quadratus Lumborum blockPatients 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 or surgery | US guided Quadratus Lumborum block |
| US guided Paravertebral block.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 or surgery | US guided Paravertebral block. |
Primary outcome
analgesic effect
Time frame: 72 hours
Visual Analogue Scale measure and needed postoperative analgesics.0 to 10, as 0 no pain 10 the worst pain.
3 secondary outcomes
Side effects
Time frame: 30 days
length of hospital stay
Time frame: 30 days
Patient satisfaction.
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Background: PubMed 18190646Arumainayagam 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.
- Background: PubMed 16905242Novotny 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.
- Background: PubMed 25025697Bulka 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.
- Background: PubMed 17312231Liu 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.
- Background: PubMed 21457153Niraj 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.
- Background: PubMed 26735154Murouchi 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.
- Background: PubMed 12071240Naja 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.
- Background: PubMed 8678263Richardson 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.
- Background: PubMed 17006061Exadaktylos 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.
- Background: PubMed 23927552Visoiu 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.
- Background: PubMed 21282032Bouzinac 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.
- Background: PubMed 4899510Aitken 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.
- Individual participant dataSharing planned: Yes. Data results and statistical analysis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad Hazem I Ahmad Sabry, MB,ChB MD principal investigator
Alexandria Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing US guided Quadratus Lumborum block and US guided Paravertebral block. in people with Pain, Postoperative, run by University of Alexandria at 1 site in Egypt.
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 6 inclusion and 8 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 15 Jan 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 Egypt. 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?
analgesic effect (time frame: 72 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 NCT03547011, which also lists 12 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 15 Jan 2019.