Comparision of three doses of oral gabapentin in reducing pain in patients undergoing gynecologic cancer surgeries

Not yet recruiting

• Conditions: Malignant neoplasm of cervix uteri, (2) ICD-10 Condition: C54||Malignant neoplasm of corpus uteri, (3) ICD-10 Condition: C55||Malignant neoplasm of uterus, partunspecified, (4) ICD-10 Condition: C56||Malignant neoplasm of ovary, (5) ICD-10 Condition: C561||Malignant neoplasm of right ovary, (6) ICD-10 Condition: C562||Malignant neoplasm of left ovary, (7) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary,

• Registration Number: CTRI/2020/05/025131
• Lead Sponsor: R KAVYA

Brief Summary

Prevention and treatment of postoperative pain continues to be a major challenge in postoperative care in gynecologic oncological surgeries and plays an important role in the early mobilization and well-being of the surgical patient.

There are different studies that have proven preemptive analgesic effect of Gabapentin but there are lack of studies regarding the optimal dose of Gabapentin as preemptive analgesic in patients undergoing elective gynecologic oncological surgeries.

The present study is designed to investigate the efficacy of three different doses of Gabapentin (600 mg, 900 mg, 1200 mg) as preemptive analgesic in gynecologic oncological surgeries and thereby finding it’s optimal dose as preemptive analgesic.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-13
• Last Update Posted: 2020-11-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 75

Inclusion Criteria

• Patients giving valid informed consent.
• Patients aged between 18 – 65 years.
• Patients belonging to ASA Grade l and ll.

Exclusion Criteria

• 1.Patients belonging to ASA Grade III and IV.
• 2.Pregnant patients.
• 3.Patients with known psychiatric disorders.
• 4.Patients on sedatives, hypnotics, antidepressant drugs.
• 5.Patients already taking oral Gabapentin.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the efficacy of three different doses of oral Gabapentin given one hour prior to surgery as preemptive analgesic to attenuate postoperative pain in patients undergoing elective gynecologic oncological surgeries under General anaesthesia by measuring following	VAS(Visual Analogue Score) score for postoperative pain will be noted at 0, 2, 4, 6, 8, 12, 16, 20, 24 hours postoperatively.
parameters:	VAS(Visual Analogue Score) score for postoperative pain will be noted at 0, 2, 4, 6, 8, 12, 16, 20, 24 hours postoperatively.
heart rate(HR),	VAS(Visual Analogue Score) score for postoperative pain will be noted at 0, 2, 4, 6, 8, 12, 16, 20, 24 hours postoperatively.
systolic blood pressure(SBP),	VAS(Visual Analogue Score) score for postoperative pain will be noted at 0, 2, 4, 6, 8, 12, 16, 20, 24 hours postoperatively.
diastolic blood pressure(DBP),	VAS(Visual Analogue Score) score for postoperative pain will be noted at 0, 2, 4, 6, 8, 12, 16, 20, 24 hours postoperatively.
mean arterial blood pressure(MAP) , sedation score,	VAS(Visual Analogue Score) score for postoperative pain will be noted at 0, 2, 4, 6, 8, 12, 16, 20, 24 hours postoperatively.
VAS score	VAS(Visual Analogue Score) score for postoperative pain will be noted at 0, 2, 4, 6, 8, 12, 16, 20, 24 hours postoperatively.

Secondary Outcome Measures

Name	Time	Method
To study and assess the degree of sedation with three different doses of Gabapentin using Ramsay sedation score.	To study and assess the incidence of side effects like dizziness, nausea and vomiting with three different doses.

Trial Locations

Locations (1)

Kidwai Memorial Institute of Oncology; 🇮🇳 Bangalore, KARNATAKA, India

Kidwai Memorial Institute of Oncology

🇮🇳Bangalore, KARNATAKA, India

R KAVYA

Principal investigator

9986713613

kavya.amrutha@gmail.com