Back to resultsErector Spinae Catheter Versus Paravertebral Catheter for Postoperative Analgesia in Cancer Patients Post Mastectomies
Primary Purpose
Post Operative Pain
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ERECTOR SPINAE PLANE BLOCK and PARAVERTEBRAL BLOCK:
PARAVERTEBRAL BLOCK:
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Pain
Eligibility Criteria
Inclusion Criteria: .Physical status ASA II. . Patients (age 20-70yrs) scheduled for breast surgeries for breast cancer under general anesthesia Exclusion Criteria: .History of psychological disorders. Known sensitivity or contraindication to local anesthetics. Localized infection at the site of block. patients with coagulopathy or an (INR ≥ 2)
Sites / Locations
- NCIEgyptRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Erecto Spinae Plane Block group
the paravertebral group
Arm Description
a high-frequency linear ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the T7 spinous process. This should reveal three muscles superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. The skin will be anaesthetized using 3ml of 2% Lidocaine. A 20-gauge block needle will be inserted in-plane in a cephalad-to-caudad direction to place the tip into the fascial plane on the deep (anterior) aspect of erector spinaemuscle;20ml bupivacaine 0.25% will be injected. The location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process The needle will be removed and the catheter secured with adhesive.
After identification of the transverse process, internal intercostal membrane (IIM), and pleura at the T3 and T6 levels, an out-of-plane needle guidance technique was used to perform the PVB.The success of both blocks will be confirmed by loss of pinprick sensation on the dermatomal site of the block •blocks will be activated ,After negative aspiration, 0.5 ml/kg 0.25% bupivacaine (max 20 ml) will be injected. Afterwards, a 20 gauge peripheral nerve catheter will be easily threaded into the space. The needle will be removed and the catheter secured with adhesive.
Outcomes
Primary Outcome Measures
Total 48 hours Post-operative opioid consumption to keep VAS score ≤4.
the VAS score rating, in which 0 = "no pain" and 10 = "worst possible pain". both during rest and movement
Secondary Outcome Measures
1st request of analgesia
1st request of analgesia , any hemodynamic instability and complications
Full Information
NCT ID
NCT05771116
First Posted
February 21, 2023
Last Updated
July 17, 2023
Sponsor
National Cancer Institute, Egypt
1. Study Identification
Unique Protocol Identification Number
NCT05771116
Brief Title
Erector Spinae Catheter Versus Paravertebral Catheter for Postoperative Analgesia in Cancer Patients Post Mastectomies
Official Title
Erector Spinae Catheter Versus Paravertebral Catheter for Pain Management in Modified Radical Mastectomy for Cancer Patients: A Randomized Double-Blind Non-inferiority Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
July 15, 2023 (Anticipated)
Study Completion Date
July 15, 2023 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
All patients admitted in National Cancer institute, Cairo University for breast surgeries will be investigated for inclusion criteria in the current study. And will be enrolled if fulfilled the criteria into 2 groups
.70 patients will be included in this prospective randomized study. The patients will be allocated into two groups: the ESPB group (group E, n = 35) , and the paravertebral group (group P, n =35)
All patients will do Ultrasound-guided ESPB for group E and PVB for group P before receiving general anesthesia
Postoperatively Patients in both groups will receive intravenous morphine 3 mg as rescue analgesic
Detailed Description
70patients will be included in this prospective randomized study. The patients will be allocated into two groups: the ESPB group (group E, n = 35) , and the paravertebral group (group P, n =35)
All patients will do Ultrasound-guided ESPB for group E and PVB for group P before receiving GA
Postoperatively Patients in both groups will receive intravenous morphine 3 mg as rescue analgesic.
Random numbers were generated using a computer-generated randomization code and were sealed in an opaque envelope. Randomization was conducted by a person who was not involved in the study.
An independent observer who was blind to the group assignment checked the intraoperative and postoperative data.
VAS pain score immediately postoperative and at 2,4,6, 8,12,18,24,36 ,48hrs.postoperative.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
An independent observer who will be blind to the group assignment checked the intraoperative and postoperative data also patient will be be blinded also
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Erecto Spinae Plane Block group
Arm Type
Active Comparator
Arm Description
a high-frequency linear ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the T7 spinous process. This should reveal three muscles superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. The skin will be anaesthetized using 3ml of 2% Lidocaine. A 20-gauge block needle will be inserted in-plane in a cephalad-to-caudad direction to place the tip into the fascial plane on the deep (anterior) aspect of erector spinaemuscle;20ml bupivacaine 0.25% will be injected. The location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process The needle will be removed and the catheter secured with adhesive.
Arm Title
the paravertebral group
Arm Type
Active Comparator
Arm Description
After identification of the transverse process, internal intercostal membrane (IIM), and pleura at the T3 and T6 levels, an out-of-plane needle guidance technique was used to perform the PVB.The success of both blocks will be confirmed by loss of pinprick sensation on the dermatomal site of the block
•blocks will be activated ,After negative aspiration, 0.5 ml/kg 0.25% bupivacaine (max 20 ml) will be injected. Afterwards, a 20 gauge peripheral nerve catheter will be easily threaded into the space. The needle will be removed and the catheter secured with adhesive.
Intervention Type
Procedure
Intervention Name(s)
ERECTOR SPINAE PLANE BLOCK and PARAVERTEBRAL BLOCK:
Intervention Description
catheter will be placed for ERECTOR SPINAE PLANE BLOCK
Intervention Type
Procedure
Intervention Name(s)
PARAVERTEBRAL BLOCK:
Intervention Description
catheter will be placed for PARAVERTEBRAL BLOCK
Primary Outcome Measure Information:
Title
Total 48 hours Post-operative opioid consumption to keep VAS score ≤4.
Description
the VAS score rating, in which 0 = "no pain" and 10 = "worst possible pain". both during rest and movement
Time Frame
48 hours postoperative
Secondary Outcome Measure Information:
Title
1st request of analgesia
Description
1st request of analgesia , any hemodynamic instability and complications
Time Frame
48 hours postoperative
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
female post mastectomy
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
.Physical status ASA II.
. Patients (age 20-70yrs) scheduled for breast surgeries for breast cancer under general anesthesia
Exclusion Criteria:
.History of psychological disorders.
Known sensitivity or contraindication to local anesthetics.
Localized infection at the site of block.
patients with coagulopathy or an (INR ≥ 2)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
suzan adlan, lecturer
Phone
01111068300
Email
dr_s.adlan@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Taher saed, lecturer
Phone
01225358877
Email
dr.taherthabet@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
suzan adlan, lecturer
Organizational Affiliation
National Cancer Institute, Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
NCIEgypt
City
Cairo
ZIP/Postal Code
11796
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
suzan adlan, lecturer
Phone
01111068300
Email
dr_s.adlan@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Erector Spinae Catheter Versus Paravertebral Catheter for Postoperative Analgesia in Cancer Patients Post Mastectomies
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