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Dexmedetomidine in Erector Spinae Block in Postoperative Analgesia

M

Mohamed Elsayed Hassan

Status

Completed

Conditions

Postoperative Pain

Treatments

Procedure: erector spinae block with bupivacaine
Procedure: erector spinae block with bupivacaine + dexmedetomidine

Study type

Interventional

Funder types

Other

Identifiers

NCT04920669
AP2014-50103

Details and patient eligibility

About

60 female patients scheduled for breast cancer surgeries, allocated in 3 groups for erector spinae block with bupivacaine and erector spinae block with dexmedetomidine added to bupivacaine and control group. During anesthesia: total intraoperative fentanyl required will be recorded. After surgery the first time of request for analgesic will be recorded. after request of analgesia all patients will be connected to PCA device containing morphine solution, the amount of morphine consumed during the first 24 hours will be recorded.

Full description

60 female patients scheduled for breast cancer surgeries, allocated in 3 groups for erector spinae block with bupivacaine and erector spinae block with dexmedetomidine added to bupivacaine and control group. During anesthesia: total intraoperative fentanyl required will be recorded. After surgery the first time of request for analgesic will be recorded. after request of analgesia all patients will be connected to PCA device containing morphine solution, the amount of morphine consumed during the first 24 hours will be recorded. Other secondary outcomes are numerical rating scales and incidence of opioid side effects.

Enrollment

58 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Female, aged (18-70) years
  • Belongs to American Society of Anaesthesiologists physical status class II.
  • Scheduled for breast cancer surgeries.

Exclusion criteria

  • Patient refusal.
  • Local infection at the site of the block.
  • Cardiac dysfunction (ejection fraction <45%).
  • Preexisting neurological or psychiatric disease, communication difficulties, inability to use the patient-controlled analgesia (PCA) device.
  • Allergy to one of the study drugs.
  • Pregnancy.
  • Coagulopathy (PC <60% and platelet count<100.000).

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

58 participants in 3 patient groups

erector spinae block
Experimental group
Description:
erector spinae block with 20 ml bupivacaine
Treatment:
Procedure: erector spinae block with bupivacaine
erector spinae block + dexmedetomidine
Experimental group
Description:
erector spinae block with 19 ml bupivacaine + dexmedetomidine
Treatment:
Procedure: erector spinae block with bupivacaine + dexmedetomidine
control group
No Intervention group
Description:
standard general anesthesia without any block

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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