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Trial Title:
Erector Spinae Catheter Versus Paravertebral Catheter for Postoperative Analgesia in Cancer Patients Post Mastectomies
NCT ID:
NCT05771116
Condition:
Post Operative Pain
Conditions: Official terms:
Pain, Postoperative
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
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
Intervention:
Intervention type:
Procedure
Intervention name:
ERECTOR SPINAE PLANE BLOCK and PARAVERTEBRAL BLOCK:
Description:
catheter will be placed for ERECTOR SPINAE PLANE BLOCK
Arm group label:
Erecto Spinae Plane Block group
Arm group label:
the paravertebral group
Intervention type:
Procedure
Intervention name:
PARAVERTEBRAL BLOCK:
Description:
catheter will be placed for PARAVERTEBRAL BLOCK
Arm group label:
Erecto Spinae Plane Block group
Arm group label:
the paravertebral group
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.
Criteria for 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)
Gender:
Female
Gender based:
Yes
Gender description:
female post mastectomy
Minimum age:
20 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
NCIEgypt
Address:
City:
Cairo
Zip:
11796
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
suzan adlan, lecturer
Phone:
01111068300
Email:
dr_s.adlan@hotmail.com
Start date:
January 1, 2023
Completion date:
July 15, 2023
Lead sponsor:
Agency:
National Cancer Institute, Egypt
Agency class:
Other
Source:
National Cancer Institute, Egypt
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05771116
