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Dexmedetomedine and Ketamine in Erector Spinae Block for Postoperative Analgesia Following Mastectomy.

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05727098
Enrollment
75
Registered
2023-02-14
Start date
2023-01-01
Completion date
2023-04-30
Last updated
2023-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

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.

Detailed 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. A systematic review and meta-analysis of experimental studies showed that the provision of effective analgesia reduces both the number and incidence of metastases in experimental cancer models . Pain may influence body homeostasis and cancer progression by pain-related immune suppression. General anesthesia is the conventional, most frequently used anesthetic technique in breast cancer surgical interventions. Various regional anesthetic techniques have also been used; these include local wound infiltration, thoracic epidural anesthesia, paravertebral block (PVB), thoracic spinal anesthesia, and more recently, ultrasound-guided interfacial plane blocks such as pectoral nerve (PECS) blocks type 1 and 2 and the serratus plane block (SPB). Recently introduced erector spinae plane block (ESPB) requires less technical expertise (easy), and may be a safe alternative to PVB. ESP block is described for treating thoracic neuropathic pain with encouraging results. ESP is a potential space deep to erector spinae muscle (ES), where the injected local anaesthetic (LA) spreads cranio-caudally up to several levels as the ES fascia extends from nuchal fascia cranially to the sacrum caudally (C7-T2 cranially and L2-L3 caudally), The block covers somatic and visceral pain during breast surgery blocks by blocking ventral rami, dorsal rami of spinal nerves, and rami communicans that transmit sympathetic fibers. There is another potentially beneficial effects of regional anaesthesia and analgesia on perioperative outcomes, these include decreased opioids consumption , lower rate of post-operative pulmonary complications, decreased post-operative nausea vomiting (PONV) and decreased duration of post-anaesthesia care unit stay. Regional anaesthesia has long-term oncological outcomes as it is considered protective for cancer recurrence by its indirect and direct antiproliferative effects. Over recent years, the addition of multiple types of additives to local anesthetics has been reported to improve analgesic effect of peripheral nerve block and regional blocks 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.

Interventions

DRUGBupivacaine Hydrochloride

injection of Bupivacaine 0.25% in ESPB

DRUGBupivacaine Hydrochloride and dexmedetomedine

injection of Bupivacaine 0.25% and dexmedetomedine in ESPB

DRUGBupivacaine Hydrochloride and ketamine

injection of Bupivacaine 0.25% and ketamine in ESPB

Sponsors

National Cancer Institute, Egypt
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Time to first rescue analgesia request postoperative24 hoursthe time of first rescue analgesia
Total opioid consumption24 hoursTotal opioid consumption

Secondary

MeasureTime frameDescription
Visual analogue scale.24 hoursCalculation of Visual analogue scale at rest and mouvement. It is 10 points scale from 0 to 10 where 0 represents no pain while 10 represents maximum pain

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026