Analgesic Protocol With Gabapentin Dexmedetomidine For Postoperative Pain Managment

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04976374

Enrollment

Registered

2021-07-26

Start date

2021-05-25

Completion date

2021-11-25

Last updated

2021-11-02

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

Conditions

Analgesia

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

Interventions

DRUGDexmedetomidine and Gabapentin

Administration of intravenous dexmedetomedine for post operative analgesic purposes in combination with gabapentin

OTHERSaline

Intravenous Saline 0.9% for placebo purposes

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Post operative morphine consumption	24 hours	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

Secondary

Measure	Time frame	Description
Post operative VAS score	24 hours	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

Countries

Egypt

Contacts

Primary Contactahmed hu bakir, MD

ahmed_bakir77@yahoo.com01115661922

Backup ContactNasr ma Abdullah, MD

01005223734

Outcome results

None listed

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