search
Back to results

Analgesic Protocol With Gabapentin Dexmedetomidine For Postoperative Pain Managment

Primary Purpose

Analgesia

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine and Gabapentin
Saline
Sponsored by
National Cancer Institute, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Analgesia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • NCI EgyptRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group A

Group B

Arm 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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 5, 2021
Last Updated
October 31, 2021
Sponsor
National Cancer Institute, Egypt
search

1. Study Identification

Unique Protocol Identification Number
NCT04976374
Brief Title
Analgesic Protocol With Gabapentin Dexmedetomidine For Postoperative Pain Managment
Official Title
A Multimodal Analgesic Protocol With Gabapentin Dexmedetomidine For Postoperative Pain Managment After Modified Radical Mastectomy Surgery: A Randomized Placebo-Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 25, 2021 (Actual)
Primary Completion Date
November 25, 2021 (Anticipated)
Study Completion Date
November 25, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Institute, Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm 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
Arm Title
Group B
Arm Type
Placebo Comparator
Arm Description
Group B will recive a bolus of saline then saline infusion identical to group A
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine and Gabapentin
Other Intervention Name(s)
gabapentin
Intervention Description
Administration of intravenous dexmedetomedine for post operative analgesic purposes in combination with gabapentin
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
Intravenous Saline 0.9% for placebo purposes
Primary Outcome Measure Information:
Title
Post operative morphine consumption
Description
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
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Post operative VAS score
Description
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
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ahmed hu bakir, MD
Phone
01115661922
Email
ahmed_bakir77@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nasr ma Abdullah, MD
Phone
01005223734
Facility Information:
Facility Name
NCI Egypt
City
Cairo
ZIP/Postal Code
02002
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed H. Bakir, M.D
Phone
01115661922
Email
ahmed_bakir77@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Study protocol, methodology and results to be shared with other researchers

Learn more about this trial

Analgesic Protocol With Gabapentin Dexmedetomidine For Postoperative Pain Managment

We'll reach out to this number within 24 hrs