Analgesia of Erector Spinae Plane Block Versus Quadratus Lumborum Block

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • DK
    • Mansourah, DK, Egypt, 050
      • Amer A Attieh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Erector spinae plane block; Patients will receive bilateral ultrasound-guided erector spinae plane block as an adjuvant analgesic technique	Other: Erector spinae plane block; 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.; Drug: Propofol; Propofol (2 mg/kg); Drug: Fentanyl NCS; Fentanyl (1µg/Kg); Drug: Atracurium Injectable Product; atracurium (0.5mg/kg); Other: Endotracheal intubation; endotracheal intubation; Drug: Anesthesia Maintenance; Inhalational isoflurane in oxygen/air mixture; Drug: Muscle Relaxation; atracurium boluses (0.2 mg/Kg/20 minutes) will be used for maintenance of general anesthesia
ACTIVE_COMPARATOR: Quadratus lumborum block; Patients will receive bilateral ultrasound-guided quadratus lumborum block as an adjuvant analgesic technique	Drug: Propofol; Propofol (2 mg/kg); Drug: Fentanyl NCS; Fentanyl (1µg/Kg); Drug: Atracurium Injectable Product; atracurium (0.5mg/kg); Other: Endotracheal intubation; endotracheal intubation; Drug: Anesthesia Maintenance; Inhalational isoflurane in oxygen/air mixture; Drug: Muscle Relaxation; atracurium boluses (0.2 mg/Kg/20 minutes) will be used for maintenance of general anesthesia; Other: Quadratus lumborum block; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From 1 day before the surgery to the 2 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic Blood Pressure	The pressure in the arteries during contraction of the heart	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	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	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	Up to 48 postoperative hours
Peripheral oxygen saturation	An estimate of oxygenated hemoglobin concentration in blood. It is measured by pulse oximeter device	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	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.	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	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	On hospital admission, 1 hour after induction of general anesthesia, 1st, 24th and 48th hours postoperatively

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Amer A Attieh, MD, Professor

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2019
• Primary Completion (ACTUAL): January 1, 2020
• Study Completion (ACTUAL): April 1, 2020

Study Registration Dates

• First Submitted: January 3, 2019
• First Submitted That Met QC Criteria: January 10, 2019
• First Posted (ACTUAL): January 14, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 3, 2020
• Last Update Submitted That Met QC Criteria: April 1, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Neuromuscular Agents; Nicotinic Antagonists; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Fentanyl; Propofol; Atracurium
• Other Study ID Numbers: MD.18.11.106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No