Colorectal CancerNCT03803267
Analgesia of Erector Spinae Plane Block Versus Quadratus Lumborum Block
A study testing Erector spinae plane block, Quadratus lumborum block and Propofol in people with Colorectal Cancer, run by Mansoura University at 1 site in Egypt.
Trial summary
Colorectal cancer is the third most common cancer worldwide. These patients usually undergo open surgical resection of cancer under general anaesthesia. The aim of this study is to detect whether the Erector spinae plan block or Quadratus lumborum block will provide the most ideal analgesia for these patients. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Erector spinae plane block, Quadratus lumborum block and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2019to 1 Apr 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists physical status I or II
- Body mass index from 18.5 to 35 Kg/m2
Who cannot join
- Body mass index more than 35 Kg/m2.
- Severe or uncompensated cardiovascular disease.
- Severe renal disease.
- Severe hepatic disease.
- Severe endocrinal disease.
- Pregnancy.
Show all 10Show fewer
- Postpartum.
- Lactating females
- Allergy to one of the agents used.
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study of Analgesic Effect of Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block for Open Colorectal Cancer Surgeries
Colorectal cancer is the third most common cancer worldwide. These patients usually undergo open surgical resection of cancer under general anaesthesia.
The aim of this study is to detect whether the Erector spinae plan block or Quadratus lumborum block will provide the most ideal analgesia for these patients. Erector spinae plan block is a novel analgesic technique that provides both visceral and somatic analgesia due to its communication with the paravertebral space. Quadratus lumborum block is a truncal nerve block usually used for intra-abdominal surgeries. Ultrasound guidance increases the accuracy and safety of both techniques. A local anaesthetic mixture of Bupivacaine 0.25% and dexamethasone will be used for both techniques.
Read the detailed description
Erector spinae plane block and quadratus lumborum block are analgesic techniques suitable for open colorectal cancer surgeries. postoperative pain score, serum levels of biomarkers of stress (cortisol and CRP), primary hemodynamics, time to first rescue analgesic request, the total amount of rescue analgesic consumption and postoperative nausea and vomiting are the parameters of comparison between both techniques.
- Conditions
- Colorectal Cancer
- Being tested
- Erector spinae plane block, Quadratus lumborum block, Propofol, Fentanyl NCS, Atracurium Injectable Product
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane blockOther
For each side, the eighth thoracic transverse process will be identified by a linear US transducer (HFL38_10-5 MHz), puncture will be performed in the plane in the craniocaudal direction until the needle contacts the transverse process, and 20 ml of bupivacaine 0.25% and 4 mg dexamethasone will be injected visualizing the hydrodissection. After 30 minutes, the degree of sensory block in the trunk will be assessed by the pinprick test and any undesirable motor weakness will be recorded as a side effect.
Quadratus lumborum blockOther
For each side, shamrock sign with three leaves (psoas major muscle anteriorly, the erector spinae muscle posteriorly and the quadratus lumborum muscle adherent to the apex of the transverse process of the L4 vertebral body) will be identified by a curved array US transducer (6-2MHz), puncture will be performed in-plane, the needle will be advanced through the quadratus lumborum muscle penetrating the ventral proper fascia of the quadratus lumborum muscle, and 20 mL of bupivacaine 0.25% and 4 mg dexamethasone will be injected in that space visualizing the hydrodissection. After 30 minutes, the degree of sensory block in the trunk will be assessed by the pinprick test and any undesired motor weakness will be recorded as a side effect
PropofolDrug
Propofol (2 mg/kg)
Fentanyl NCSDrug
Fentanyl (1µg/Kg)
Atracurium Injectable ProductDrug
atracurium (0.5mg/kg)
Endotracheal intubationOther
endotracheal intubation
Anesthesia MaintenanceDrug
Inhalational isoflurane in oxygen/air mixture
Muscle RelaxationDrug
atracurium boluses (0.2 mg/Kg/20 minutes) will be used for maintenance of general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Erector spinae plane block | Active comparator | Patients will receive bilateral ultrasound-guided erector spinae plane block as an adjuvant analgesic technique Receives: Other: Erector spinae plane block; Drug: Propofol; Drug: Fentanyl NCS; Drug: Atracurium Injectable Product; Other: Endotracheal intubation; Drug: Anesthesia Maintenance; Drug: Muscle Relaxation |
| Quadratus lumborum block | Active comparator | Patients will receive bilateral ultrasound-guided quadratus lumborum block as an adjuvant analgesic technique Receives: Other: Quadratus lumborum block; Drug: Propofol; Drug: Fentanyl NCS; Drug: Atracurium Injectable Product; Other: Endotracheal intubation; Drug: Anesthesia Maintenance; Drug: Muscle Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain score
The intensity of pain indicated by a segmented numeric scale in which a respondent selects a whole number (0-100 integers) that best reflects his/her pain as 0-30 for mild pain, 30-60 for moderate pain and 60-100 for sever pain
Measured: From 1 day before the surgery to the 2 days after surgery
Secondary outcomes (9)
Systolic Blood Pressure
The pressure in the arteries during contraction of the heart
Measured: One hour before induction of general anesthesia, every 10 minutes till end of surgery, every 4 hours till end of the first 24 hours postoperatively, then every 8 hours till end of the next 24 hours
Mean Blood Pressure
: The average pressure in the arteries during one cardiac cycle. It is a better indicator for vital organs' perfusion than the systolic pressure
Measured: One hour before induction of general anesthesia, every 10 minutes till end of surgery, every 4 hours till end of the first 24 hours postoperatively, then every 8 hours till end of the next 24 hours
Heart rate
The number of heart beats per minute. A lower heart rate at rest implies a more efficient heart function, better cardiovascular fitness and less stress
Measured: One hour before induction of general anesthesia, every 10 minutes till end of surgery, every 4 hours till end of the first 24 hours postoperatively, then every 8 hours till end of the next 24 hours
Time to first rescue analgesic request
The time elapsed from termination of performing each block till the patient's request for analgesia. It resembles the duration of analgesia
Measured: Up to 48 postoperative hours
Peripheral oxygen saturation
An estimate of oxygenated hemoglobin concentration in blood. It is measured by pulse oximeter device
Measured: One hour before induction of general anesthesia, every 10 minutes till end of surgery, every 4 hours till end of the first 24 hours postoperatively, then every 8 hours till end of the next 24 hours
Total amount of rescue analgesic consumption
The total amount of morphine consumed by the patient for pain relief over the 48 hours postoperatively
Measured: From the time of first analgesic request till the end of the first 24 hours, then till the end of the next 24 hours postoperatively
Postoperative nausea and vomiting intensity score
Postoperative Nausea and Vomiting Intensity Scale: A scale that evaluates postoperative nausea and vomiting. It equals severity of nausea (1=mild, 2= moderate, 3= sever) x pattern of nausea (1=varying, 2= constant) x duration of nausea (in hours). At any time, if it is < 50 or vomiting occurs once or twice, it is clinically unimportant (good outcome). If it is ≥50 or vomiting occurs 3 or more times, it is clinically important (bad outcome). The sum of all values will quantify the entire period of the study.
Measured: Immediately after recovery, every 4 hours till end of the first 24 hours postoperatively, then every 8 hours till end of the next 24 hours
Cortisol
A steroid hormone secreted by adrenal cortex in response to stress and hypoglycemia
Measured: At 9 Am, 1 hour after induction of general anesthesia, 1st, 24th and 48th hours postoperatively
Serum C-reactive protein (CRP)
A protein synthetized by hepatocytes in response to systemic inflammation or tissue damage
Measured: On hospital admission, 1 hour after induction of general anesthesia, 1st, 24th and 48th hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start1 May 2019
- Primary completion1 Jan 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amer A Attieh, MD, Study chair, ProfessorMohammed A Ghanem, MD, Study director, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03803267
- Sponsor's protocol ID
- MD.18.11.106
- Status last verified
- Apr 2020
- First submitted
- 3 Jan 2019
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Analgesic Effect of Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block for Open Colorectal Cancer Surgeries
- ClinicalTrials.gov ID
- NCT03803267
- Acronym / sponsor ID
- MD.18.11.106
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 14 Jan 2019 (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.
Colorectal cancer is the third most common cancer worldwide. These patients usually undergo open surgical resection of cancer under general anaesthesia.
The aim of this study is to detect whether the Erector spinae plan block or Quadratus lumborum block will provide the most ideal analgesia for these patients. Erector spinae plan block is a novel analgesic technique that provides both visceral and somatic analgesia due to its communication with the paravertebral space. Quadratus lumborum block is a truncal nerve block usually used for intra-abdominal surgeries. Ultrasound guidance increases the accuracy and safety of both techniques. A local anaesthetic mixture of Bupivacaine 0.25% and dexamethasone will be used for both techniques.
Detailed description
Erector spinae plane block and quadratus lumborum block are analgesic techniques suitable for open colorectal cancer surgeries. postoperative pain score, serum levels of biomarkers of stress (cortisol and CRP), primary hemodynamics, time to first rescue analgesic request, the total amount of rescue analgesic consumption and postoperative nausea and vomiting are the parameters of comparison between both techniques.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector spinae plane block | Active comparator | Other: Erector spinae plane block, Drug: Propofol, Drug: Fentanyl NCS, Drug: Atracurium Injectable Product, Other: Endotracheal intubation, Drug: Anesthesia Maintenance, Drug: Muscle RelaxationPatients will receive bilateral ultrasound-guided erector spinae plane block as an adjuvant analgesic technique |
| Quadratus lumborum block | Active comparator | Other: Quadratus lumborum block, Drug: Propofol, Drug: Fentanyl NCS, Drug: Atracurium Injectable Product, Other: Endotracheal intubation, Drug: Anesthesia Maintenance, Drug: Muscle RelaxationPatients will receive bilateral ultrasound-guided quadratus lumborum block as an adjuvant analgesic technique |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists physical status I or II
- Body mass index from 18.5 to 35 Kg/m2
Key exclusion criteria (10 listed)
- Body mass index more than 35 Kg/m2.
- Severe or uncompensated cardiovascular disease.
- Severe renal disease.
- Severe hepatic disease.
- Severe endocrinal disease.
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 |
|---|---|---|
| Erector spinae plane blockFor each side, the eighth thoracic transverse process will be identified by a linear US transducer (HFL38_10-5 MHz), puncture will be performed in the plane in the craniocaudal direction until the needle contacts the transverse process, and 20 ml of bupivacaine 0.25% and 4 mg dexamethasone will be injected visualizing the hydrodissection. After 30 minutes, the degree of sensory block in the trunk will be assessed by the pinprick test and any undesirable motor weakness will be recorded as a side effect. | Other | Erector spinae plane block |
| Quadratus lumborum blockFor each side, shamrock sign with three leaves (psoas major muscle anteriorly, the erector spinae muscle posteriorly and the quadratus lumborum muscle adherent to the apex of the transverse process of the L4 vertebral body) will be identified by a curved array US transducer (6-2MHz), puncture will be performed in-plane, the needle will be advanced through the quadratus lumborum muscle penetrating the ventral proper fascia of the quadratus lumborum muscle, and 20 mL of bupivacaine 0.25% and 4 mg dexamethasone will be injected in that space visualizing the hydrodissection. After 30 minutes, the degree of sensory block in the trunk will be assessed by the pinprick test and any undesired motor weakness will be recorded as a side effect | Other | Quadratus lumborum block |
| PropofolPropofol (2 mg/kg) | Drug | Erector spinae plane block, Quadratus lumborum block |
| Fentanyl NCSFentanyl (1µg/Kg) | Drug | Erector spinae plane block, Quadratus lumborum block |
| Atracurium Injectable Productatracurium (0.5mg/kg) | Drug | Erector spinae plane block, Quadratus lumborum block |
| Endotracheal intubationendotracheal intubation | Other | Erector spinae plane block, Quadratus lumborum block |
| Anesthesia MaintenanceInhalational isoflurane in oxygen/air mixture | Drug | Erector spinae plane block, Quadratus lumborum block |
| Muscle Relaxationatracurium boluses (0.2 mg/Kg/20 minutes) will be used for maintenance of general anesthesia | Drug | Erector spinae plane block, Quadratus lumborum block |
Primary outcome
Postoperative pain score
Time frame: From 1 day before the surgery to the 2 days after surgery
The intensity of pain indicated by a segmented numeric scale in which a respondent selects a whole number (0-100 integers) that best reflects his/her pain as 0-30 for mild pain, 30-60 for moderate pain and 60-100 for sever pain
9 secondary outcomes
Systolic Blood Pressure
Time frame: One hour before induction of general anesthesia, every 10 minutes till end of surgery, every 4 hours till end of the first 24 hours postoperatively, then every 8 hours till end of the next 24 hours
Mean Blood Pressure
Time frame: One hour before induction of general anesthesia, every 10 minutes till end of surgery, every 4 hours till end of the first 24 hours postoperatively, then every 8 hours till end of the next 24 hours
Heart rate
Time frame: One hour before induction of general anesthesia, every 10 minutes till end of surgery, every 4 hours till end of the first 24 hours postoperatively, then every 8 hours till end of the next 24 hours
Time to first rescue analgesic request
Time frame: Up to 48 postoperative hours
Peripheral oxygen saturation
Time frame: One hour before induction of general anesthesia, every 10 minutes till end of surgery, every 4 hours till end of the first 24 hours postoperatively, then every 8 hours till end of the next 24 hours
Total amount of rescue analgesic consumption
Time frame: From the time of first analgesic request till the end of the first 24 hours, then till the end of the next 24 hours postoperatively
Postoperative nausea and vomiting intensity score
Time frame: Immediately after recovery, every 4 hours till end of the first 24 hours postoperatively, then every 8 hours till end of the next 24 hours
Cortisol
Time frame: At 9 Am, 1 hour after induction of general anesthesia, 1st, 24th and 48th hours postoperatively
Serum C-reactive protein (CRP)
Time frame: On hospital admission, 1 hour after induction of general anesthesia, 1st, 24th and 48th hours postoperatively
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 3 Apr 2020.
- Individual participant dataSharing planned: Undecided
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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.
Amer A Attieh, MD study chair
Professor
Mohammed A Ghanem, MD study director
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector spinae plane block, Quadratus lumborum block and Propofol in people with Colorectal Cancer, run by Mansoura University 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 2 inclusion and 10 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 3 Apr 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 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?
Postoperative pain score (time frame: From 1 day before the surgery to the 2 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2020.