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Erector Spinae Catheter Versus Paravertebral Catheter for Postoperative Analgesia in Cancer Patients Post Mastectomies

N

National Cancer Institute, Egypt

Status

Enrolling

Conditions

Post Operative Pain

Treatments

Procedure: PARAVERTEBRAL BLOCK:
Procedure: ERECTOR SPINAE PLANE BLOCK and PARAVERTEBRAL BLOCK:

Study type

Interventional

Funder types

Other

Identifiers

NCT05771116
AP2212-501-034

Details and patient eligibility

About

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

Full 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.

Enrollment

70 estimated patients

Sex

Female

Ages

20 to 70 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

70 participants in 2 patient groups

Erecto Spinae Plane Block group
Active Comparator group
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.
Treatment:
Procedure: ERECTOR SPINAE PLANE BLOCK and PARAVERTEBRAL BLOCK:
Procedure: PARAVERTEBRAL BLOCK:
the paravertebral group
Active Comparator group
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.
Treatment:
Procedure: ERECTOR SPINAE PLANE BLOCK and PARAVERTEBRAL BLOCK:
Procedure: PARAVERTEBRAL BLOCK:

Trial contacts and locations

1

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Central trial contact

Taher saed, lecturer; suzan adlan, lecturer

Data sourced from clinicaltrials.gov

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