Clinical trial

Comparative Study Between Dexmedetomedine and Ketamine in Erector Spinae Plane Block for Postoperative Analgesia Following Modified Radical Mastectomy. A Prospective Randomized Controlled Study.

Name
Erector block after mastectomy
Description
Persistent pain after breast cancer surgery is frequently observed in more than 60% of patients.The suboptimal management of perioperative pain can lead to the occurrence of persistent breast cancer pain syndrome and phantom breast pain. Dexmedetomidine, a novel α2-agonist with an eight-fold affinity for α2-adrenergic receptors (sedate and analgesic effects) as clonidine, while exerts much less α1-effects., has been found to significantly increase the duration of peripheral nerve blocks, with minimal systemic side effects. Ketamine is a non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptors. It is used for sedation, premedication, induction, and maintenance of general anesthesia. Central, regional, and local anesthetic and analgesic properties have been reported for ketamine. Both can be used through Erector spinae plane block for postoperative pain control.
Trial arms
Trial start
2023-01-01
Estimated PCD
2023-04-30
Trial end
2023-04-30
Status
Completed
Phase
Early phase I
Treatment
Bupivacaine Hydrochloride
injection of Bupivacaine 0.25% in ESPB
Arms:
Bupivacaine
Other names:
local anesthetic
Bupivacaine Hydrochloride and dexmedetomedine
injection of Bupivacaine 0.25% and dexmedetomedine in ESPB
Arms:
Bupivacaine and dexmedetomedine
Other names:
local anesthetic and dexmedetomedine
Bupivacaine Hydrochloride and ketamine
injection of Bupivacaine 0.25% and ketamine in ESPB
Arms:
Bupivacaine and Ketamine
Other names:
local anesthetic and ketamine
Size
75
Primary endpoint
Time to first rescue analgesia request postoperative
24 hours
Total opioid consumption
24 hours
Eligibility criteria
Inclusion Criteria: * ASA I or II . * female aged between 18 to 65. Scheduled for elective modified radical mastectomy under general anesthesia. Exclusion Criteria: * Patient known to have allergy to any of the drugs used in the study. * Infection at injection site. * Coagulation disorders. * severe heart ,liver or kidney disease. * Unwillingness.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 75, 'type': 'ACTUAL'}}
Updated at
2023-06-08

1 organization

3 products

1 indication

Indication
Breast Cancer