Clinical trial NCT03803267: 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
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2019-01-14
Enrollment: 68
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Postoperative pain score
timeFrame: From 1 day before the surgery to the 2 days after surgery
Secondary outcomes:
measure: Systolic Blood Pressure
timeFrame: 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
measure: Mean Blood Pressure
timeFrame: 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
measure: Heart rate
timeFrame: 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
measure: Time to first rescue analgesic request
timeFrame: Up to 48 postoperative hours
measure: Peripheral oxygen saturation
timeFrame: 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
measure: Total amount of rescue analgesic consumption
timeFrame: 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
measure: Postoperative nausea and vomiting intensity score
timeFrame: 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
measure: Cortisol
timeFrame: At 9 Am, 1 hour after induction of general anesthesia, 1st, 24th and 48th hours postoperatively
measure: Serum C-reactive protein (CRP)
timeFrame: On hospital admission, 1 hour after induction of general anesthesia, 1st, 24th and 48th hours postoperatively
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Amer A Attieh
state: DK
Study officials:
affiliation: Professor
name: Amer A Attieh, MD
role: STUDY_CHAIR
affiliation: Associate Professor
name: Mohammed A Ghanem, MD
role: STUDY_DIRECTOR
References: