Analgesia of Erector Spinae Plane Block Versus Quadratus Lumborum Block

Colorectal Cancer Clinical Trial

Official title:

A Comparative Study of Analgesic Effect of Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block for Open Colorectal Cancer Surgeries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03803267
• Other study ID #: MD.18.11.106
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: April 2020
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: April 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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.
• 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)
• Fentanyl NCS
Fentanyl (1µg/Kg)
• Atracurium Injectable Product
atracurium (0.5mg/kg)

Other:
• Endotracheal intubation
endotracheal intubation

Drug:
• Anesthesia Maintenance
Inhalational isoflurane in oxygen/air mixture
• Muscle Relaxation
atracurium boluses (0.2 mg/Kg/20 minutes) will be used for maintenance of general anesthesia

Locations

Country	Name	City	State
Egypt	Amer A Attieh	Mansourah	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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