Clinical trial NCT04541732: Postoperative Analgesia of Quadratus Lumborum Block Versus Epidural Block After Major Abdominal Surgeries
Official title: Ultra-sound Guided Bilateral Quadratus Lumborum Block Versus Epidural Block for Postoperative Analgesia After Major Abdominal Surgeries.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elective Major Abdominal Surgery
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-09-09
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blind study
Primary purpose: PREVENTION

Brief summary: Acute postoperative pain is an important issue after major abdominal surgeries for which different analgesic modalities have been tried.

Epidural analgesia is the recommended technique to relieve pain after major abdominal surgeries owing to the proved superior analgesia, reduction of opioid-related side effects as nausea, vomiting, pruritis and sedation, earlier recovery of bowel function and earlier ability for postoperative mobility. However, it is not without complications.

Quadratus lumborum block is an ultrasound-guided block that provides patients with both visceral and somatic blockade. It lessens the potential risks associated with neuraxial techniques, so it may represent a novel alternative approach for analgesia after major abdominal surgeries.

Detailed description: The aim of this study is to detect the feasibility of ultra-sound guided bilateral quadratus lumborum block as a postoperative analgesic modality after major abdominal surgery in comparison to epidural block and its effects on total rescue analgesic requirements in the 1st postoperative 24hours, time to first analgesic request, pain VAS scores, intraoperative and postoperative hemodynamics and postoperative opioid-related side effects.

Under complete aseptic conditions, the patients will receive either thoracic epidural block or bilateral ultrasound-guided quadratus lumborum block after induction of general anaesthesia

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I-III

Exclusion Criteria:

* Patient's refusal
* Significant cardiac, disease.
* Significant hepatic disease.
* Significant renal disease (serum creatinine ˃ 1.5 mg/dl).
* Patients with drug abuse
* Allergy to study medications
* Mental disease
* Communication barrier.
* Coagulopathy.
* Local skin infection

Primary outcomes:
measure: Postoperative 24 hours cumulative rescue morphine consumption
timeFrame: For 24 hours after surgery
Secondary outcomes:
measure: The duration of postoperative analgesia
timeFrame: For 24 hours after surgery
measure: Postoperative pain score at rest
timeFrame: For 24 hours after surgery
measure: Postoperative pain score on movement
timeFrame: For 24 hours after surgery
measure: Postoperative pain score on cough
timeFrame: For 24 hours after surgery
measure: Systolic blood pressure
timeFrame: For 28 hours after induction of anesthesia
measure: Diastolic blood pressure
timeFrame: For 28 hours after induction of anesthesia
measure: Mean blood pressure
timeFrame: For 28 hours after induction of anesthesia
measure: Heart rate
timeFrame: For 28 hours after induction of anesthesia
measure: Degree of postoperative nausea and vomiting
timeFrame: For 24 hours after surgery
measure: Pruritis
timeFrame: For 24 hours after surgery
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mohammed A Ghanem
state: DK
Study officials:
affiliation: Associate Professor
name: Mohammed A Ghanem, MD
role: STUDY_DIRECTOR
affiliation: Professor
name: Mona A Hasheesh, MD
role: STUDY_CHAIR
References: