Breast Cancer Surgery Pain
Conditions
Keywords
Gabapentin, Breast neoplasm, pain, postoperative, analgesics, opoid, morphine
Brief summary
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.
Detailed description
This study will be carried out after approval from scientific and ethical review committee. Patient who fulfill the criteria will be enrolled in this study. Written and informed consent will be taken from study participants. Patients will be randomly allocated (as mentioned above) either in to group A (Gabapentin) or group B (placebo). Patients in Group A will be given oral gabapentin 600 mg10 one hour before surgery while patients in group B will be given oral placebo (Tablet sodium bicarbonate) one hour before surgery. . Induction of anesthesia will be done using propofol 1.5-2 mg/kg, atracurium 0.5 mg/kg and fentanyl 1 mcg/kg. Both group of patients will undergo general anesthesia with supra glottic airway device. Anesthesia will be maintained using sevoflurane using MAC 0.8-1.0. Both group of patients will receive intravenous paracetamol 1 gram, ketorolac 30 mg and local infiltration (bupivacaine) upto 2mg/kg. Intravenous morphine (0.1 mg/kg) will be administered intra operatively as rescue analgesia if blood pressure or/and heart rate increases 20 % above baseline. Ondansetron IV, 4 mg, was administered 30 minutes before to the conclusion of operation. After surgery patients will be transferred to recovery area. Patients will be monitored for pain score for a period of their whole stay in recovery area using numeric rating scale. The post-anesthesia care unit was transferred with the patients. In recovery area, adverse effects such pain, drowsiness, nausea, vomiting, and others were monitored. If the pain is score is greater than 2, then intra venous morphine 0.1 mg/kg will be administered as a bolus. Therefore in both group of patients total morphine used for each patient during their stay in recovery will be noted. Data will be collected on Performa attached at the end.
Interventions
A single perioperative 600 mg dose of oral Gabapentin significantly reduces intraoperative and postoperative morphine consumption.
A single perioperative dose of oral Vitamin B complex tablet given as Placebo.
Sponsors
Study design
Intervention model description
Randomized controlled trial. STUDY SETTING: Hospital: Shaukat khanum Memorial hospital Lahore Department: Anesthesia department DURATION: 6 months after approval of synopsis. SAMPLE SIZE: The sample size is calculated by using an open epi WHO sample size calculator. Taking relevant statistics from previous study10 for the gabapentin group as post-operative mean morphine consumption 11.0 mg and standard deviation (SD) 2.0 mg and for placebo mean morphine consumption 13.1 mg and standard deviation (SD) 2.25 mg10. Power of study 95 %, 95 % Confidence interval (CI) and assuming 10% drop-out rate. The calculated sample size came out as 30 patients in each group. The total sample size would be 60 patients.
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To compare post-operative mean morphine consumption between Single Dose of Preoperative Oral Gabapentin versus Placebo in Patients Undergoing Breast Surgery | 2 hours post surgery | This study aims to compare postoperative morphine consumption in patients undergoing breast surgery who receive a single preoperative dose of oral gabapentin versus placebo. The primary outcome will be the total amount of morphine required during the postoperative recovery period. The study will determine whether preoperative gabapentin reduces postoperative opioid requirements and improves pain management. |
Countries
Pakistan