Analgesic Protocol With Gabapentin Dexmedetomidine For Postoperative Pain Managment

National Cancer Institute, Egypt

Status: Unknown

Conditions: Analgesia

Treatments: Other: Saline; Drug: Dexmedetomidine and Gabapentin

Study type: Interventional

Funder types: Other

Identifiers

NCT04976374

AP2105-50105

Details and patient eligibility

About

Assessment of quality of post mastectomy analgesic protocol of Gabapentin and Dexmedetomedine in a placebo-controlled study

Full description

Assessment of quality of post mastectomy analgesic protocol of Gabapentin and Dexmedetomedine in a placebo-controlled study.

Dexmedetomidine is a highly selective X2 adrenergic receptor aganist; it has anxiolytic, sedative, analgesic and sympathdytic properties without significant respiratory depressant effects. Research evidence has shown that this drug protects the body (including heart, nerves, etc.) against ischemia and hypoxic injury. Therefore, dexmedetomidine can be one of the best options for reducing pain after surgery.

Gabapentin, a structural analog of gamma aminobutyric acid, is used as an anticonvulsant drug since 1993. In addition it has been effective in neuropathic pain, diabetic neuropathy and reflex sympathetic dystrophy. It acts through binding to the X-2-5 subvnits of voltagegated calcium ion channels and preventing the central sentization and hyperalgesia. Gabapentin has demonstrated to inhibit the development and establishment of hyperalgesia and secondry allodynia in human volunteers.

Gabapentin may also decrease postoperative obioid requirement through preventing the tolerance development. Furthermore, it has minimal or no effect on gastric mucosa, renal function, and platelets count or activity in the perioperative period to be prefer over nonsteroidal anti-inflammatory drugs.

The Combination of both drugs will be tested for potentiation of post-operative analgesia and decrease of opioid consumptions

Enrollment: 30 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult female patients below 65 years of age scheduled for modified radical mastectomy surgery, American society of Anesthesiologists(ASA) physical status I-II

Exclusion criteria

• known allergy to study drugs; patients already taking oral gabapentin, knal or hepatic defunction, current treatment with narcotics, antihypertensives, benzodiazepines, X2 agonists, antiepileptics and antipsychotics

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

Group A

Active Comparator group

Description:

Patients of group A will start dexmedetomidine (precedex 100 ug lmL, Hospira) infusion 0.4 ug {Kg}h after bolus of 0.5 ug 1 kg intravenously over 10 min

Treatment:

Drug: Dexmedetomidine and Gabapentin

Group B

Placebo Comparator group

Description:

Group B will recive a bolus of saline then saline infusion identical to group A

Treatment:

Other: Saline