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

Primary Purpose

Erector Spinae Plane Block, Thoracic Epidural Analgesia, Nephrectomy

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Thoracic epidural analgesia
Ultrasound guided continuous erector spinae plane block
Sponsored by
National Cancer Institute, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erector Spinae Plane Block

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Thoracic epidural analgesia group

Ultrasound guided continuous erector spinae plane block group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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.
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.
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.
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.
Changes in postoperative mean arterial blood pressure
It will be recorded immediately postoperative and at 1, 2, 4, 6, 12 and 24 h postoperatively.
Changes in postoperative heart rate
It will be recorded immediately postoperative and at 1, 2, 4, 6, 12 and 24 h 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
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

Full Information

First Posted
June 23, 2021
Last Updated
December 30, 2021
Sponsor
National Cancer Institute, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT04947644
Brief Title
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

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2021 (Actual)
Primary Completion Date
May 14, 2022 (Anticipated)
Study Completion Date
June 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute, Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erector Spinae Plane Block, Thoracic Epidural Analgesia, Nephrectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Thoracic epidural analgesia group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Ultrasound guided continuous erector spinae plane block group
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Thoracic epidural analgesia
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Ultrasound guided continuous erector spinae plane block
Intervention Description
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
Primary Outcome Measure Information:
Title
Total morphine consumption within 24 hours postoperative
Description
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.
Time Frame
First 24 hours postoperatively.
Secondary Outcome Measure Information:
Title
Total intra-operative fentanyl consumption.
Description
Elevation of heart rate or mean arterial blood pressure ≥ 20% of the baseline will be treated by fentanyl 0.5 μg / kg
Time Frame
Intra-operative
Title
The time of first rescue analgesia.
Description
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
Time Frame
First 24 hours postoperatively.
Title
Pain using Numerical rating scale (NRS) at rest
Description
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.
Time Frame
First 24 hours postoperatively.
Title
Pain using Numerical rating scale (NRS) during movement
Description
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.
Time Frame
First 24 hours postoperatively.
Title
Changes in Intraoperative heart rate
Description
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.
Time Frame
Intraoperatively
Title
Changes in Intraoperative mean arterial pressure
Description
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.
Time Frame
Intraoperatively
Title
Changes in postoperative mean arterial blood pressure
Description
It will be recorded immediately postoperative and at 1, 2, 4, 6, 12 and 24 h postoperatively.
Time Frame
First 24 hours postoperatively.
Title
Changes in postoperative heart rate
Description
It will be recorded immediately postoperative and at 1, 2, 4, 6, 12 and 24 h postoperatively.
Time Frame
First 24 hours postoperatively.
Title
Total dose of bupivacaine consumption.
Description
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
Time Frame
First 24 hours postoperatively.
Title
The incidence of various side effects .
Description
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
Time Frame
Intra-operative and first 24 hours postoperatively.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud Abd elgalil, MD
Phone
00201285332068
Email
dr.ma7moud-abdelgilil@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud Abd elgalil, MD
Organizational Affiliation
Assistant Lecturer of Anesthesia ,Pain Relief and ICU National Cancer Institute ,Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Institute
City
Cairo
ZIP/Postal Code
11796
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atef Badran, MD
Phone
+(202) 2532 82 86
Email
irb@nci.cu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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