Clinical trial NCT04947644: Ultrasound-guided Continuous Erector Spinae Plane Block Versus Thoracic Epidural Analgesia in Open Nephrectomy
Official title: Comparative Study of Ultrasound-guided Continuous Erector Spinae Plane Block Versus Thoracic Epidural Analgesia in Open Nephrectomy for Renal Malignancy: A Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Erector Spinae Plane Block
Thoracic Epidural Analgesia
Nephrectomy
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 54
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: There are different case studies about the use of erector spinae block (ESPB ) in nephrectomy, but there are no enough randomized controlled studies about it until now so it will be one of the earliest studies that investigate the effect of ESPB to relief acute postoperative pain in patients undergoing open nephrectomy.

Although ESPB and thoracic epidural analgesia blocks successfully reduced postoperative opioid consumption in previous studies, no study has ever compared their efficacy in postoperative analgesia of adult patients undergoing open nephrectomy under general anesthesia thus in this randomized comparative study we are aiming to fill this gap in the literature.

The aim of this study is to compare the analgesic effect of ultrasound-guided continuous erector spinae plane block versus thoracic epidural analgesia in open nephrectomy for renal cancer patients.

Detailed description: The erector spinae muscle (ESM) is a complex formed by the spinalis, longissimus thoracis, and iliocostalis muscles that run vertically in the back. The ESP block is performed by depositing the local anesthetic (LA) in the fascial plane, deeper than the ESM at the tip of the transverse process of the vertebra. Hence, LA is distributed in the cranio-caudal fascial plane. Additionally, it diffuses anteriorly to the paravertebral and epidural spaces, and laterally to the intercostal space at several levels.

Cadaveric studies was done on ESPB using MRI to evaluate the spread of local anesthetic mixed with gadolinium dye. Showed the spread of injected volume of 30 ml at level of T10 spread between the level of T5 and T12 . Other cadaveric study showed the spread of the dye to thoracic paravertebral space which may explain the visceral analgesic effect of the block.

There are different case studies about the use of erector spinae block (ESPB ) in nephrectomy, but there are no enough randomized controlled studies about it until now so it will be one of the earliest studies that investigate the effect of ESPB to relief acute postoperative pain in patients undergoing open nephrectomy.

Although ESPB and thoracic epidural analgesia blocks successfully reduced postoperative opioid consumption in previous studies, no study has ever compared their efficacy in postoperative analgesia of adult patients undergoing open nephrectomy under general anesthesia thus in this randomized comparative study we are aiming to fill this gap in the literature.

The aim of this study is to compare the analgesic effect of ultrasound-guided continuous erector spinae plane block versus thoracic epidural analgesia in open nephrectomy for renal cancer patients.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists class II.
* Patients undergoing open nephrectomy for malignant renal tumors.
* Body mass index (BMI): \> 20 kg/m2 and \< 40 kg/m2.

Exclusion Criteria:

* Patient refusal.
* Local infection at the puncture site.
* Coagulopathies with platelet count below 50,000 or an international normalized ratio \>1.6.
* Renal and hepatic insufficiency.
* Unstable cardiovascular disease.
* History of psychiatric and cognitive disorders.
* Patients allergic to medication used.
* Abnormal anatomy of the thoracic region.

Primary outcomes:
measure: Total morphine consumption within 24 hours postoperative
timeFrame: First 24 hours postoperatively.
Secondary outcomes:
measure: Total intra-operative fentanyl consumption.
timeFrame: Intra-operative
measure: The time of first rescue analgesia.
timeFrame: First 24 hours postoperatively.
measure: Pain using Numerical rating scale (NRS) at rest
timeFrame: First 24 hours postoperatively.
measure: Pain using Numerical rating scale (NRS) during movement
timeFrame: First 24 hours postoperatively.
measure: Changes in Intraoperative heart rate
timeFrame: Intraoperatively
measure: Changes in Intraoperative mean arterial pressure
timeFrame: Intraoperatively
measure: Changes in postoperative mean arterial blood pressure
timeFrame: First 24 hours postoperatively.
measure: Changes in postoperative heart rate
timeFrame: First 24 hours postoperatively.
measure: Total dose of bupivacaine consumption.
timeFrame: First 24 hours postoperatively.
measure: The incidence of various side effects .
timeFrame: Intra-operative and first 24 hours postoperatively.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Cancer Institute
Study officials:
affiliation: Assistant Lecturer of Anesthesia ,Pain Relief and ICU National Cancer Institute ,Cairo University
name: Mahmoud Abd elgalil, MD
role: PRINCIPAL_INVESTIGATOR
References: