Analgesia of Erector Spinae Plane Block Versus Quadratus Lumborum Block

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Other: Quadratus lumborum block; Other: Erector spinae plane block; Drug: Propofol; Drug: Fentanyl NCS; Drug: Atracurium Injectable Product; Other: Endotracheal intubation; Drug: Anesthesia Maintenance; Drug: Muscle Relaxation

• Registration Number: NCT03803267
• Lead Sponsor: Mansoura University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-01-03
• Study First Submitted QC: 2019-01-10
• Study First Posted: 2019-01-14
• Study Start: 2019-05-01
• Primary Completion: 2020-01-01
• Status Verified: 2020-04
• Study Completion: 2020-04-01
• Last Update Submitted: 2020-04-01
• Last Update Posted: 2020-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quadratus lumborum block	Atracurium Injectable Product	Patients will receive bilateral ultrasound-guided quadratus lumborum block as an adjuvant analgesic technique
Erector spinae plane block	Propofol	Patients will receive bilateral ultrasound-guided erector spinae plane block as an adjuvant analgesic technique
Quadratus lumborum block	Muscle Relaxation	Patients will receive bilateral ultrasound-guided quadratus lumborum block as an adjuvant analgesic technique
Erector spinae plane block	Fentanyl NCS	Patients will receive bilateral ultrasound-guided erector spinae plane block as an adjuvant analgesic technique
Erector spinae plane block	Atracurium Injectable Product	Patients will receive bilateral ultrasound-guided erector spinae plane block as an adjuvant analgesic technique
Erector spinae plane block	Muscle Relaxation	Patients will receive bilateral ultrasound-guided erector spinae plane block as an adjuvant analgesic technique
Quadratus lumborum block	Propofol	Patients will receive bilateral ultrasound-guided quadratus lumborum block as an adjuvant analgesic technique
Quadratus lumborum block	Quadratus lumborum block	Patients will receive bilateral ultrasound-guided quadratus lumborum block as an adjuvant analgesic technique
Quadratus lumborum block	Fentanyl NCS	Patients will receive bilateral ultrasound-guided quadratus lumborum block as an adjuvant analgesic technique
Erector spinae plane block	Endotracheal intubation	Patients will receive bilateral ultrasound-guided erector spinae plane block as an adjuvant analgesic technique
Erector spinae plane block	Erector spinae plane block	Patients will receive bilateral ultrasound-guided erector spinae plane block as an adjuvant analgesic technique
Erector spinae plane block	Anesthesia Maintenance	Patients will receive bilateral ultrasound-guided erector spinae plane block as an adjuvant analgesic technique
Quadratus lumborum block	Endotracheal intubation	Patients will receive bilateral ultrasound-guided quadratus lumborum block as an adjuvant analgesic technique
Quadratus lumborum block	Anesthesia Maintenance	Patients will receive bilateral ultrasound-guided quadratus lumborum block as an adjuvant analgesic technique

Primary Outcome Measures

Name	Time	Method
Postoperative pain score	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

Secondary Outcome Measures

Name	Time	Method
Systolic Blood Pressure	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	The pressure in the arteries during contraction of the heart
Peripheral oxygen saturation	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	An estimate of oxygenated hemoglobin concentration in blood. It is measured by pulse oximeter device
Time to first rescue analgesic request	Up to 48 postoperative hours	The time elapsed from termination of performing each block till the patient's request for analgesia. It resembles the duration of analgesia
Postoperative nausea and vomiting intensity score	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	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.
Heart rate	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	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
Serum C-reactive protein (CRP)	On hospital admission, 1 hour after induction of general anesthesia, 1st, 24th and 48th hours postoperatively	A protein synthetized by hepatocytes in response to systemic inflammation or tissue damage
Mean Blood Pressure	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	: The average pressure in the arteries during one cardiac cycle. It is a better indicator for vital organs' perfusion than the systolic pressure
Total amount of rescue analgesic consumption	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	The total amount of morphine consumed by the patient for pain relief over the 48 hours postoperatively
Cortisol	At 9 Am, 1 hour after induction of general anesthesia, 1st, 24th and 48th hours postoperatively	A steroid hormone secreted by adrenal cortex in response to stress and hypoglycemia

Trial Locations

Locations (1)

Amer A Attieh; 🇪🇬 Mansourah, DK, Egypt