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Post Operative Pain in Modified Radical Mastectomy.

Primary Purpose

Post Operative Pain

Status
Unknown status
Phase
Early Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
capule gabapentin
Sponsored by
Combined Military Hospital, Pakistan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Operative Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • All Females, age ranged between 20 to 80 years and diagnosed with breast carcinoma stage II on the basis of triple assessment will be recruited in the study

Exclusion Criteria:

  • Patients who will refuse to participate in the study, allergic to gabapentin on the basis if history, previous treatment with Gabapentin in previous 8 weeks , Chronic pain syndrome, Substance abuse, sedatives, hypnotics or antidepressants ,analgesic intake within 48 hours before surgery, Diabetes mellitus, Hypertension and Acute or Chronic Renal Failure on the basis of medical records

Sites / Locations

  • AnumRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control group

intervention group

Arm Description

routuine analgesics wil be given

patient will receive cap gabapentin 1200 mg 2 hours before surgery

Outcomes

Primary Outcome Measures

post operative pain score
Visual analog score for pain from 0 to 10. O means no pain. 1 is least and 10 is most severe pain

Secondary Outcome Measures

analgesia requirement
change in analgesic requirement a i either groups

Full Information

First Posted
November 4, 2020
Last Updated
November 4, 2020
Sponsor
Combined Military Hospital, Pakistan
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1. Study Identification

Unique Protocol Identification Number
NCT04620720
Brief Title
Post Operative Pain in Modified Radical Mastectomy.
Official Title
Post Operative Pain in Modified Radical Mastectomy.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Combined Military Hospital, Pakistan

4. Oversight

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

5. Study Description

Brief Summary
we will assess post operative pain after surgery of modified radical mastectomy at 12 and 24 hours post operatively on arm movement and on rest
Detailed Description
This Randomised control trial will be conducted at the Department of General Surgery, Dow University Hospital OJHA Campus Karachi over a period of a year. All Females, ages ranged between 20 to 80 years and diagnosed with breast carcinoma stage II on the basis of triple assessment will be recruited in the study. Patients who will refuse to participate in the study, allergic to gabapentin on the basis if history, previous treatment with Gabapentin in the previous 8 weeks, Chronic pain syndrome, Substance abuse, sedatives, hypnotics or antidepressants, analgesic intake within 48 hours before surgery, Diabetes mellitus, Hypertension, and Acute or Chronic Renal Failure on the basis of medical records and Inability to understand VAS pain score will be excluded from the study. The sample size will be calculated by the Open Epi calculator. The mean pain score difference at rest between two groups was taken as 0.7 (Placebo: mean ± SD = 2.9 ± 1.2 and Gabapentin: mean ± SD = 2.2 ± 1.3.5 With 80% power, and 95% confidence level, the total sample size came out to be 102, 51 patients in each group. Consecutive sampling was used to achieve the desired sample. Patients fulfilling inclusion criteria were randomly enrolled in either of the 2 groups by sealed opaque envelop method bearing cards, which will be picked by the staff nurses. The intervention group was labeled as group A and the control group as group B. Patients in the intervention group received a single dose of 1200 mg of gabapentin 2hours before surgery. All procedures were performed under general anesthesia. Postoperative analgesic injection ketorolac 30 mg thrice a day and injection paracetamol 1 gram intravenous thrice a day was advised. Patients were assessed at 12 and 24 h post-operatively for pain scores at rest and arm mobilization using VAS pain score, a number of times rescue analgesia when VAS score > 3 by residents of surgery blinded to the study. Those patients, who experience pain (pain score > 3) in spite of routine analgesics received injection ketorolac 30 mg once, pain score between 3 to 6 received injection Kinz, pain score > 7 will be given both analgesics single times, pain score >8 will receive intravenous maximum thrice in 24 hours. Patients with pain score 0-2 will not be given any additional analgesic All patients will receive antiemetic in Metoclopramide 10 mg I.V in case of nausea and vomiting. All demographics and outcome variables will be entered in the proforma. The outcome variables of the study were age, pain score (VAS), and analgesic requirement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
routuine analgesics wil be given
Arm Title
intervention group
Arm Type
Experimental
Arm Description
patient will receive cap gabapentin 1200 mg 2 hours before surgery
Intervention Type
Drug
Intervention Name(s)
capule gabapentin
Intervention Description
neuropathic analgesic
Primary Outcome Measure Information:
Title
post operative pain score
Description
Visual analog score for pain from 0 to 10. O means no pain. 1 is least and 10 is most severe pain
Time Frame
12 hours post oepratively
Secondary Outcome Measure Information:
Title
analgesia requirement
Description
change in analgesic requirement a i either groups
Time Frame
12 hours post oepratively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All Females, age ranged between 20 to 80 years and diagnosed with breast carcinoma stage II on the basis of triple assessment will be recruited in the study Exclusion Criteria: Patients who will refuse to participate in the study, allergic to gabapentin on the basis if history, previous treatment with Gabapentin in previous 8 weeks , Chronic pain syndrome, Substance abuse, sedatives, hypnotics or antidepressants ,analgesic intake within 48 hours before surgery, Diabetes mellitus, Hypertension and Acute or Chronic Renal Failure on the basis of medical records
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anum Arif, MBBS FCPS
Phone
+923422398424
Email
dranumarif@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ammad Asim, MBBS FCPS
Phone
+923422398424
Email
ammadasim@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anum Arif, MBBS FCPS
Organizational Affiliation
Combined military hospital lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anum
City
Karachi
State/Province
Select A State Or Province
ZIP/Postal Code
00921
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anum Arif, MBBS FCPS
Phone
03422398424
Email
dranumarif@yahoo.com
First Name & Middle Initial & Last Name & Degree
ammad asim, MBBS FCPS
Phone
+923422398424
Email
AMMADASIM@GMAIL.COM

12. IPD Sharing Statement

Plan to Share IPD
No

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Post Operative Pain in Modified Radical Mastectomy.

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