Erector Spinae Plane Block for Post-nephrectomy Pain
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Morphine patient controlled analgesia
Erector Spinae plane block
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
Eligibility Criteria
Inclusion Criteria:
- Physical status ASA II.
- Age ≥ 18 and ≤ 65 Years.
- Body mass index (BMI): > 20 kg/m2 and < 40 kg/m2.
Exclusion Criteria:
- Patient refusal
- Known sensitivity or contraindication to local anesthetics.
- History of psychological disorders.
Localized infection at the site of block.
- Coagulopathies with platelet count below 50,000 or an INR>1.5.
Sites / Locations
- National Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
patient controlled analgesia
Erector Spinae plane block
Arm Description
30 patients will receive only postoperative IV PCA alone for postoperative analgesia.
30 patients will receive continuous ESPB for postoperative analgesia.
Outcomes
Primary Outcome Measures
measurement of visual analogue score
it is a scoring system from 0 to 100 mm where 100 represents the worst pain and 0 indicates no pain
Secondary Outcome Measures
Full Information
NCT ID
NCT04537598
First Posted
August 28, 2020
Last Updated
July 20, 2022
Sponsor
National Cancer Institute, Egypt
1. Study Identification
Unique Protocol Identification Number
NCT04537598
Brief Title
Erector Spinae Plane Block for Post-nephrectomy Pain
Official Title
Ultrasound Guided Continuous Erector Spinae Plane Block Versus Patient Controlled Analgesia in Patients Undergoing Nephrectomy for Renal Malignancies: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
March 3, 2020 (Actual)
Primary Completion Date
May 28, 2022 (Actual)
Study Completion Date
June 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
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
Acute postoperative pain proper management is important not only for patient satisfaction but also for patient outcome. It may also predispose patients to chronic post-surgical pain .Open nephrectomy is still conducted, although the use of laparoscopic or robotic surgery has increased recently. A flank approach with an eleventh rib partial resection.Several modalities have been implemented for acute postoperative pain control. Intravenous (IV) opioids is one of the earliest and most widely used method, it is insufficient only for managing postoperative pain in some patients with severe pain besides their side effects.ESPB is a relatively simple technique with easily identified sonographic landmarks. Additionally, the ESPB has the potential to provide both somatic and visceral sensory blockade.The aim of this study is to evaluate the effect of ESPB in acute postoperative pain and opioid consumption in patients undergoing open nephrectomy in renal cancer patients.
Detailed Description
Acute postoperative pain proper management is important not only for patient satisfaction but also for patient outcome. In addition to its early effects, poorly controlled acute postoperative pain may predispose patients to chronic post-surgical pain.
Open nephrectomy is still conducted, although the use of laparoscopic or robotic surgery has increased recently. A flank approach with an eleventh rib partial resection, which is the main method for open nephrectomy at our institution, could make for better dissection of the renal pelvis and the pedicles, and provide the best circumstances for nephrectomy; however, it induces more persistent pain compared with other approaches.
Several modalities have been implemented for acute postoperative pain control. Intravenous (IV) opioids is one of the earliest and most widely used method, it is insufficient only for managing postoperative pain in some patients with severe pain. In addition, opioids have many side effects like respiratory depression, nausea, vomiting and constipation hence it is important to decrease opioids use and the transition to other modalities such as regional blocks, nerve blocks, NSAIDs and multimodalities.ESPB is a relatively simple technique with easily identified sonographic landmarks. Additionally, the ESPB has the potential to provide both somatic and visceral sensory blockade.
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.
There are different case studies about the use of erector spinae block in nephrectomy but there is no randomized controlled study 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.
The aim of this study is to evaluate the effect of ESPB in acute postoperative pain and opioid consumption in patients undergoing open nephrectomy in renal cancer patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patient controlled analgesia
Arm Type
Active Comparator
Arm Description
30 patients will receive only postoperative IV PCA alone for postoperative analgesia.
Arm Title
Erector Spinae plane block
Arm Type
Active Comparator
Arm Description
30 patients will receive continuous ESPB for postoperative analgesia.
Intervention Type
Procedure
Intervention Name(s)
Morphine patient controlled analgesia
Intervention Description
30 patients will receive PCA only for postoperative analgesia
Intervention Type
Procedure
Intervention Name(s)
Erector Spinae plane block
Intervention Description
30 patients will receive continuous ESPB for postoperative analgesia
Primary Outcome Measure Information:
Title
measurement of visual analogue score
Description
it is a scoring system from 0 to 100 mm where 100 represents the worst pain and 0 indicates no pain
Time Frame
1 week
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:
Physical status ASA II.
Age ≥ 18 and ≤ 65 Years.
Body mass index (BMI): > 20 kg/m2 and < 40 kg/m2.
Exclusion Criteria:
Patient refusal
Known sensitivity or contraindication to local anesthetics.
History of psychological disorders.
Localized infection at the site of block.
Coagulopathies with platelet count below 50,000 or an INR>1.5.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ehab H Gendy, MD
Organizational Affiliation
Assistant Professor of Anesthesia, intensive care and pain releif
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Institute
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
we can share IPD after journal accepting the manuscript
Learn more about this trial
Erector Spinae Plane Block for Post-nephrectomy Pain
We'll reach out to this number within 24 hrs