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Analgesia of Erector Spinae Plane Block Versus Quadratus Lumborum Block

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03803267
Recruitment Status : Completed
First Posted : January 14, 2019
Last Update Posted : April 3, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Other: Erector spinae plane block Other: Quadratus lumborum block Drug: Propofol Drug: Fentanyl NCS Drug: Atracurium Injectable Product Other: Endotracheal intubation Drug: Anesthesia Maintenance Drug: Muscle Relaxation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Single blind (participant) study
Primary Purpose: Supportive Care
Official Title: A Comparative Study of Analgesic Effect of Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block for Open Colorectal Cancer Surgeries
Actual Study Start Date : May 1, 2019
Actual Primary Completion Date : January 1, 2020
Actual Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine


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
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

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]
    The pressure in the arteries during contraction of the heart

  2. 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 ]
    : The average pressure in the arteries during one cardiac cycle. It is a better indicator for vital organs' perfusion than the systolic pressure

  3. 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 ]
    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

  4. Time to first rescue analgesic request [ Time Frame: 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

  5. 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 ]
    An estimate of oxygenated hemoglobin concentration in blood. It is measured by pulse oximeter device

  6. 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 ]
    The total amount of morphine consumed by the patient for pain relief over the 48 hours postoperatively

  7. 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 ]
    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.

  8. Cortisol [ Time Frame: 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

  9. Serum C-reactive protein (CRP) [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03803267


Locations
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Egypt
Amer A Attieh
Mansourah, DK, Egypt, 050
Sponsors and Collaborators
Mansoura University
Investigators
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Study Chair: Amer A Attieh, MD Professor
Study Director: Mohammed A Ghanem, MD Associate Professor
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Responsible Party: Mansoura University
ClinicalTrials.gov Identifier: NCT03803267    
Other Study ID Numbers: MD.18.11.106
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: April 3, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Fentanyl
Propofol
Atracurium
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Nicotinic Antagonists