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Analgesic Protocol With Gabapentin Dexmedetomidine For Postoperative Pain Managment

NCT ID: NCT04976374

Last Updated: 2021-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-25

Study Completion Date

2021-11-25

Brief Summary

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

Detailed Description

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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

Conditions

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Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Group A

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

Group Type ACTIVE_COMPARATOR

Dexmedetomidine and Gabapentin

Intervention Type DRUG

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

Group B

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

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type OTHER

Intravenous Saline 0.9% for placebo purposes

Interventions

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Dexmedetomidine and Gabapentin

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

Intervention Type DRUG

Saline

Intravenous Saline 0.9% for placebo purposes

Intervention Type OTHER

Other Intervention Names

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gabapentin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Bakir

Assistant Professor of Anesthesia, Intensive care and Pain Relief

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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NCI Egypt

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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ahmed hu bakir, MD

Role: CONTACT

Phone: 01115661922

Email: [email protected]

Nasr ma Abdullah, MD

Role: CONTACT

Phone: 01005223734

Facility Contacts

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Ahmed H. Bakir, M.D

Role: primary

Other Identifiers

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AP2105-50105

Identifier Type: -

Identifier Source: org_study_id