Ultrasound-guided Continuous Erector Spinae Plane Block Versus Thoracic Epidural Analgesia in Open Nephrectomy

Comparative Study of Ultrasound-guided Continuous Erector Spinae Plane Block Versus Thoracic Epidural Analgesia in Open Nephrectomy for Renal Malignancy: A Randomized Controlled Study.

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.

Study Overview

• Status: Recruiting
• Conditions: Erector Spinae Plane Block; Nephrectomy; Thoracic Epidural Analgesia
• Intervention / Treatment: Procedure: Thoracic epidural analgesia; Procedure: Ultrasound guided continuous erector spinae plane block

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.

• Study Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mahmoud Abd elgalil, MD; Phone Number: 00201285332068; Email: dr.ma7moud-abdelgilil@yahoo.com

Study Locations

• Egypt
  • Cairo, Egypt, 11796
    • Recruiting
    • National Cancer Institute
    • Contact: Atef Badran, MD; Phone Number: +(202) 2532 82 86; Email: irb@nci.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Thoracic epidural analgesia group; After negative response, 10 ml of 0.25% bupivacaine will be injected as a bolus dose in the epidural catheter in 5ml divided aliquots at 5min intervals, 30 min before the induction of general anesthesia and the patient will be turned to the supine position. Sensory block will be assessed in operated side by loss of pinprick sensation in midclavicular line every 2 min. After 15min, if the sensory block level was still below T5, an additional 5ml bupivacaine was given. Then followed by continuous infusion of bupivacaine 0.125% at a rate of 6 ml/h that will be started before skin incision and the dose was increased in 2 ml/h increments up to 10 ml/h for 24 hours. Rate adjustment according to pain score and side effects	Procedure: Thoracic epidural analgesia; After negative response, 10 ml of 0.25% bupivacaine will be injected as a bolus dose in the epidural catheter in 5ml divided aliquots at 5min intervals, 30 min before the induction of general anesthesia and the patient will be turned to the supine position. Sensory block will be assessed in operated side by loss of pinprick sensation in midclavicular line every 2 min. After 15min, if the sensory block level was still below T5, an additional 5ml bupivacaine was given. Then followed by continuous infusion of bupivacaine 0.125% at a rate of 6 ml/h that will be started before skin incision and the dose was increased in 2 ml/h increments up to 10 ml/h for 24 hours. Rate adjustment according to pain score and side effects
Experimental: Ultrasound guided continuous erector spinae plane block group; After verifying the correct space with hydrodissection by 5mL of saline 0.9%, lifting erector spinae muscle off the bony shadow of the transverse process, a catheter was inserted was inserted 3 cm beyond the needle tip and 20 ml of 0.25% bupivacaine will be injected as a bolus dose in the epidural catheter in 10 ml divided aliquots at 5min intervals, 30 min before the induction of general anesthesia and the patient will be turned to the supine position. Sensory block will be assessed in operated side by loss of pinprick sensation in midclavicular line every 2 min. After 15min, if the sensory block level was still below T5, an additional 5ml bupivacaine was given. Then followed by continuous infusion of bupivacaine 0.125% at a rate of 6 ml/h that will be started before skin incision and the dose was increased in 2 ml/h increments up to 10 ml/h for 24 hours. Rate adjustment according to pain score and side effects	Procedure: Ultrasound guided continuous erector spinae plane block; After verifying the correct space with hydrodissection by 5mL of saline 0.9%, lifting erector spinae muscle off the bony shadow of the transverse process, a catheter was inserted was inserted 3 cm beyond the needle tip and 20 ml of 0.25% bupivacaine will be injected as a bolus dose in the epidural catheter in 10 ml divided aliquots at 5min intervals, 30 min before the induction of general anesthesia and the patient will be turned to the supine position. Sensory block will be assessed in operated side by loss of pinprick sensation in midclavicular line every 2 min. After 15min, if the sensory block level was still below T5, an additional 5ml bupivacaine was given. Then followed by continuous infusion of bupivacaine 0.125% at a rate of 6 ml/h that will be started before skin incision and the dose was increased in 2 ml/h increments up to 10 ml/h for 24 hours. Rate adjustment according to pain score and side effects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total morphine consumption within 24 hours postoperative	Rescue analgesia will be provided in the form of intravenous morphine 3 mg with maximum dose of 0.1 mg/kg/dose (max 0.3 mg/kg/day) boluses if the pain score >3. The total amount of morphine given in 24 hours will be recorded for every patient.	First 24 hours postoperatively.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total intra-operative fentanyl consumption.	Elevation of heart rate or mean arterial blood pressure ≥ 20% of the baseline will be treated by fentanyl 0.5 μg / kg	Intra-operative
The time of first rescue analgesia.	Rescue analgesia will be provided in the form of intravenous morphine 3 mg with maximum dose of 0.1 mg/kg/dose (max 0.3 mg/kg/day) boluses if the pain score >3	First 24 hours postoperatively.
Pain using Numerical rating scale (NRS) at rest	Pain scores using NRS will be recorded in the post anaesthesia care unit , and for the next 24 hours (1, 2, 4, 6, 12 and 24h) postoperatively. Scores (1-3) are considered mild pain, (4-6) moderate pain and (7-10) severe pain.	First 24 hours postoperatively.
Pain using Numerical rating scale (NRS) during movement	Pain scores using NRS will be recorded in the post anaesthesia care unit , and for the next 24 hours (1, 2, 4, 6, 12 and 24h) postoperatively. Scores (1-3) are considered mild pain, (4-6) moderate pain and (7-10) severe pain.	First 24 hours postoperatively.
Changes in Intraoperative heart rate	It will be recorded before injection of the local anesthetics to be defined as a baseline reading and follow up after injection then will be recorded immediately before and after surgical incision and at 30 min intervals intraoperatively.	Intraoperatively
Changes in Intraoperative mean arterial pressure	It will be recorded before injection of the local anesthetics to be defined as a baseline reading and follow up after injection then will be recorded immediately before and after surgical incision and at 30 min intervals intraoperatively.	Intraoperatively
Changes in postoperative mean arterial blood pressure	It will be recorded immediately postoperative and at 1, 2, 4, 6, 12 and 24 h postoperatively.	First 24 hours postoperatively.
Changes in postoperative heart rate	It will be recorded immediately postoperative and at 1, 2, 4, 6, 12 and 24 h postoperatively.	First 24 hours postoperatively.
Total dose of bupivacaine consumption.	In thoracic epidural analgesia group 10 ml of 0.25% bupivacaine will be injected as a bolus dose in the epidural catheter in 5ml divided aliquots at 5min intervals. After 15min, if the sensory block level was still below T5, an additional 5ml bupivacaine was given. In erector spinae plane block group 20 ml of 0.25% bupivacaine will be injected as a bolus dose in the epidural catheter in 10 ml divided aliquots at 5min intervals. After 15min, if the sensory block level was still below T5, an additional 5ml bupivacaine was given. In both groups: Then followed by continuous infusion of bupivacaine 0.125% at a rate of 6 ml/h that will be started before skin incision and the dose was increased in 2 ml/h increments up to 10 ml/h for 24 hours. Rate adjustment according to pain score and side effects	First 24 hours postoperatively.
The incidence of various side effects .	such as hemodynamic instability, nausea, vomiting, dural puncture with the needle or the catheter, post dural puncture headache, failed block, unintentional intravascular injection of local anesthetic, local anesthetic toxicity and respiratory depression (respiratory rate <10/minute) will be recorded	Intra-operative and first 24 hours postoperatively.

Collaborators and Investigators

• Sponsor: National Cancer Institute, Egypt
• Investigators: Principal Investigator: Mahmoud Abd elgalil, MD, Assistant Lecturer of Anesthesia ,Pain Relief and ICU National Cancer Institute ,Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2021
• Primary Completion (Anticipated): May 14, 2022
• Study Completion (Anticipated): June 15, 2022

Study Registration Dates

• First Submitted: June 23, 2021
• First Submitted That Met QC Criteria: June 23, 2021
• First Posted (Actual): July 1, 2021

Study Record Updates

• Last Update Posted (Actual): January 14, 2022
• Last Update Submitted That Met QC Criteria: December 30, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Aneurysm; Perceptual Disorders; Aneurysm, Dissecting; Agnosia
• Other Study ID Numbers: 2015-301-015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The data will be available upon reasonable request from the corresponding author.
• IPD Sharing Time Frame: one year from after the end of the study.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No