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Analgesia of Erector Spinae Plane Block Versus Quadratus Lumborum Block

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Erector spinae plane block
Quadratus lumborum block
Propofol
Fentanyl NCS
Atracurium Injectable Product
Endotracheal intubation
Anesthesia Maintenance
Muscle Relaxation
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colorectal Cancer

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesiologists physical status I or II
  • Body mass index from 18.5 to 35 Kg/m2

Exclusion Criteria:

  • Body mass index more than 35 Kg/m2.
  • Severe or uncompensated cardiovascular disease.
  • Severe renal disease.
  • Severe hepatic disease.
  • Severe endocrinal disease.
  • Pregnancy.
  • Postpartum.
  • Lactating females
  • Allergy to one of the agents used.
  • Refusal to participate in the study.

Sites / Locations

  • Amer A Attieh

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Erector spinae plane block

Quadratus lumborum block

Arm Description

Patients will receive bilateral ultrasound-guided erector spinae plane block as an adjuvant analgesic technique

Patients will receive bilateral ultrasound-guided quadratus lumborum block as an adjuvant analgesic technique

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Systolic Blood Pressure
The pressure in the arteries during contraction of the heart
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
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
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
Peripheral oxygen saturation
An estimate of oxygenated hemoglobin concentration in blood. It is measured by pulse oximeter device
Total amount of rescue analgesic consumption
The total amount of morphine consumed by the patient for pain relief over the 48 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.
Cortisol
A steroid hormone secreted by adrenal cortex in response to stress and hypoglycemia
Serum C-reactive protein (CRP)
A protein synthetized by hepatocytes in response to systemic inflammation or tissue damage

Full Information

First Posted
January 3, 2019
Last Updated
April 1, 2020
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT03803267
Brief Title
Analgesia of Erector Spinae Plane Block Versus Quadratus Lumborum Block
Official Title
A Comparative Study of Analgesic Effect of Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block for Open Colorectal Cancer Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Single blind (participant) study
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erector spinae plane block
Arm Type
Active Comparator
Arm Description
Patients will receive bilateral ultrasound-guided erector spinae plane block as an adjuvant analgesic technique
Arm Title
Quadratus lumborum block
Arm Type
Active Comparator
Arm Description
Patients will receive bilateral ultrasound-guided quadratus lumborum block as an adjuvant analgesic technique
Intervention Type
Other
Intervention Name(s)
Erector spinae plane block
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Quadratus lumborum block
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
Propofol (2 mg/kg)
Intervention Type
Drug
Intervention Name(s)
Fentanyl NCS
Intervention Description
Fentanyl (1µg/Kg)
Intervention Type
Drug
Intervention Name(s)
Atracurium Injectable Product
Intervention Description
atracurium (0.5mg/kg)
Intervention Type
Other
Intervention Name(s)
Endotracheal intubation
Intervention Description
endotracheal intubation
Intervention Type
Drug
Intervention Name(s)
Anesthesia Maintenance
Intervention Description
Inhalational isoflurane in oxygen/air mixture
Intervention Type
Drug
Intervention Name(s)
Muscle Relaxation
Intervention Description
atracurium boluses (0.2 mg/Kg/20 minutes) will be used for maintenance of general anesthesia
Primary Outcome Measure Information:
Title
Postoperative pain score
Description
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
Time Frame
From 1 day before the surgery to the 2 days after surgery
Secondary Outcome Measure Information:
Title
Systolic Blood Pressure
Description
The pressure in the arteries during contraction of the heart
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
Title
Mean Blood Pressure
Description
: The average pressure in the arteries during one cardiac cycle. It is a better indicator for vital organs' perfusion than the systolic 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
Title
Heart rate
Description
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
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
Title
Time to first rescue analgesic request
Description
The time elapsed from termination of performing each block till the patient's request for analgesia. It resembles the duration of analgesia
Time Frame
Up to 48 postoperative hours
Title
Peripheral oxygen saturation
Description
An estimate of oxygenated hemoglobin concentration in blood. It is measured by pulse oximeter device
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
Title
Total amount of rescue analgesic consumption
Description
The total amount of morphine consumed by the patient for pain relief over the 48 hours postoperatively
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
Title
Postoperative nausea and vomiting intensity score
Description
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.
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
Title
Cortisol
Description
A steroid hormone secreted by adrenal cortex in response to stress and hypoglycemia
Time Frame
At 9 Am, 1 hour after induction of general anesthesia, 1st, 24th and 48th hours postoperatively
Title
Serum C-reactive protein (CRP)
Description
A protein synthetized by hepatocytes in response to systemic inflammation or tissue damage
Time Frame
On hospital admission, 1 hour after induction of general anesthesia, 1st, 24th and 48th hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists physical status I or II Body mass index from 18.5 to 35 Kg/m2 Exclusion Criteria: Body mass index more than 35 Kg/m2. Severe or uncompensated cardiovascular disease. Severe renal disease. Severe hepatic disease. Severe endocrinal disease. Pregnancy. Postpartum. Lactating females Allergy to one of the agents used. Refusal to participate in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amer A Attieh, MD
Organizational Affiliation
Professor
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mohammed A Ghanem, MD
Organizational Affiliation
Associate Professor
Official's Role
Study Director
Facility Information:
Facility Name
Amer A Attieh
City
Mansourah
State/Province
DK
ZIP/Postal Code
050
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Analgesia of Erector Spinae Plane Block Versus Quadratus Lumborum Block

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