Analgesic Protocol With Gabapentin Dexmedetomidine For Postoperative Pain Managment

Study Overview
=================
Brief Summary
-----------------
Assessment of quality of post mastectomy analgesic protocol of Gabapentin and Dexmedetomedine in a placebo-controlled study

Detailed 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

Official Title
-----------------
A Multimodal Analgesic Protocol With Gabapentin Dexmedetomidine For Postoperative Pain Managment After Modified Radical Mastectomy Surgery: A Randomized Placebo-Controlled Study

Conditions
-----------------
Analgesia

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine and Gabapentin
* Other: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>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 | Drug: Dexmedetomidine and Gabapentin<br>* Administration of intravenous dexmedetomedine for post operative analgesic purposes in combination with gabapentin<br>* Other names: gabapentin;|
| Placebo Comparator: Group B<br>Group B will recive a bolus of saline then saline infusion identical to group A | Other: Saline<br>* Intravenous Saline 0.9% for placebo purposes<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative morphine consumption | Evaluation of the effects of combining and gabapentin and dexmedetomidine infusion on post operative morphine consumption within the first 24 h in patients undergoing modified radical mastectomy surgery | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative VAS score | Evaluation of the effects of combining and gabapentin and dexmedtomidine infusion on post operative visual analogue scale (VAS) score within the first 24 h in patients undergoing modified radical mastectomy surgery | 24 hours |