NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Sponsor: Shaukat Khanum Memorial Cancer Hospital & Research Centre
Conditions: Breast Cancer Surgery Pain
Interventions: Oral Gabapentin pre-op, Vitamin B complex tablets (Neurorubine TM -Forte Lactab TM)
Countries: Pakistan
The study will be conducted after approval from the Scientific and Ethical Review Committees. Eligible patients will be enrolled after obtaining written informed consent and randomly allocated to Group A (gabapentin) or Group B (placebo). Group A will receive oral gabapentin 600 mg one hour before surgery, while Group B will receive oral placebo (sodium bicarbonate) at the same time. General anesthesia will be induced with propofol, atracurium, and fentanyl and maintained with sevoflurane using a supraglottic airway device. Both groups will receive IV paracetamol, ketorolac, and local bupivacaine infiltration. Intraoperative rescue analgesia with IV morphine will be given if hemodynamic parameters increase by \>20% from baseline. Postoperatively, patients will be monitored in the recovery area for pain using the Numeric Rating Scale (NRS) and for adverse effects including drowsiness, nausea, and vomiting. IV morphine 0.1 mg/kg will be administered if the NRS pain score is \>2. The total morphine consumption during recovery will be recorded for both groups. Data will be collected using the attached proforma.
Sex: FEMALE
Age: 18 Years to 60 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: 1. Age between 18 to 60 years. 2. Female Gender 3. American Society of Anesthesiologists grade 1 and 2 patients. 4. Elective breast surgery 5. Admitted and day case surgeries Exclusion Criteria: 1. Patients allergic to gabapentin 2. Patients refusal. 3. Patients having a history of chronic pain. 4. Patients already using opioids for pain control
- Lahore, Punjab Province, Pakistan