Clinical trial NCT06580704: Lumbosacral Erector Spinae Plane Block Versus Psoas Muscle Compartment With Sciatic Nerve Block for Anesthesia for Unilateral Lower Limb Operations in Critically Ill Patients
Official title: Lumbosacral Erector Spinae Plane Block Versus Psoas Muscle Compartment With Sciatic Nerve Block for Anesthesia for Unilateral Lower Limb Operations in Critically Ill Patients: A Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbosacral
Erector Spinae Plane Block
Psoas Muscle Compartment Block
Sciatic Nerve Block
Anesthesia
Unilateral
Lower Limb
Critically Ill Patients
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare lumbosacral erector spinae plane block and psoas muscle compartment with sciatic nerve block in unilateral lower limb operations in critically ill patients.

Detailed description: The lower limb surgeries are associated with acute postoperative pain and require long-term analgesia. Regional anesthesia is often used to prevent postoperative pain. Ultrasound-guided regional anesthetic approaches provide a simple intraoperative pathway that lowers pain scores with less impact on the respiratory or cardiovascular system.

Psoas compartment block (PCB) is a peripheral regional technique of anesthesia, which provides a block of the main components of the lumbar plexus - the femoral, lateral cutaneous nerve of the femur and sciatic nerve. In combination with the sciatic nerve block, the psoas compartment block provides effective anesthesia of the entire lower extremity, with better hemodynamic stability.

The erector Spinae plane block (ESPB) is a novel regional block technique primarily introduced in 2016 for managing severe neuropathic pain.

Eligibility criteria: * Age from 18 to 65 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status III, IV.
* Critically ill patients admitted to intensive care unit.
* Undergoing unilateral lower limb operations.

Exclusion Criteria:

* History of allergy to local anesthetics.
* Bleeding tendency.
* Coagulopathy.
* Anticoagulant therapy.
* Pre-existing psychological, neurologic, and spinal cord diseases.
* Previous back surgery.
* Infection or mass at the site of the block.
* Chronic analgesic therapy.
* Severe cardiac or renal diseases.

Primary outcomes:
measure: Incidence of failure
timeFrame: Intraoperatively
Secondary outcomes:
measure: Hear rate
timeFrame: Every 15 minutes till the end of surgery (up to 2 hours)
measure: Mean arterial pressure
timeFrame: Every 15 minutes till the end of surgery (up to 2 hours)
measure: Duration of analgesia
timeFrame: Till the first request of rescue analgesic drug (up to 24 hours after surgery)
measure: Degree of pain
timeFrame: 24 hours postoperatively
measure: Degree of patient satisfaction
timeFrame: 24 hours postoperatively
measure: Incidence of adverse events
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References: