Post Operative Pain in Modified Radical Mastectomy.

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

Study Overview

• Status: Unknown
• Conditions: Post Operative Pain
• Intervention / Treatment: Drug: capule gabapentin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 51
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Pakistan
  • Select A State Or Province
    • Karachi, Select A State Or Province, Pakistan, 00921
      • Recruiting
      • Anum
      • Contact: ammad asim, MBBS FCPS; Phone Number: +923422398424; Email: AMMADASIM@GMAIL.COM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; routuine analgesics wil be given
Experimental: intervention group; patient will receive cap gabapentin 1200 mg 2 hours before surgery	Drug: capule gabapentin; neuropathic analgesic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 hours post oepratively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
analgesia requirement	change in analgesic requirement a i either groups	12 hours post oepratively

Collaborators and Investigators

• Sponsor: Combined Military Hospital, Pakistan
• Investigators: Principal Investigator: Anum Arif, MBBS FCPS, Combined military hospital lahore

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: November 4, 2020
• First Submitted That Met QC Criteria: November 4, 2020
• First Posted (Actual): November 9, 2020

Study Record Updates

• Last Update Posted (Actual): November 9, 2020
• Last Update Submitted That Met QC Criteria: November 4, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin
• Other Study ID Numbers: DUHSKK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No