Post Operative Pain in Modified Radical Mastectomy.

NCT ID: NCT04620720

Last Updated: 2020-11-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2020-12-01

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.

Conditions

Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

control group

routuine analgesics wil be given

Group Type: NO_INTERVENTION

No interventions assigned to this group

intervention group

patient will receive cap gabapentin 1200 mg 2 hours before surgery

Group Type: EXPERIMENTAL

capule gabapentin

Intervention Type: DRUG

neuropathic analgesic

Interventions

capule gabapentin

neuropathic analgesic

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Combined Military Hospital, Pakistan

OTHER

Sponsor Role: lead

Responsible Party

Dr Anum Arif

Dr Anum Arif

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anum Arif, MBBS FCPS

Role: PRINCIPAL_INVESTIGATOR

Combined military hospital lahore

Locations

Anum

Karachi, Select A State Or Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Anum Arif, MBBS FCPS

Role: CONTACT

Phone: +923422398424

Email: dranumarif@yahoo.com

Ammad Asim, MBBS FCPS

Role: CONTACT

Phone: +923422398424

Email: ammadasim@gmail.com

Facility Contacts

Anum Arif, MBBS FCPS

Role: primary

ammad asim, MBBS FCPS

Role: backup

Other Identifiers

DUHSKK

Identifier Type: -

Identifier Source: org_study_id