Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Scalp block with ketamine and levobupivacaine: 1mg/kg of Inj Ketamine and 28 mL of 0.5 % levobupivacaine, diluted to a total volume of 30 mL for bilateral scalp block
Control Interventi
Sponsors
All India Institute of Medical Sciences, Bathinda
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients between 18-70 years of age 2. Patients scheduled for elective supratentorial craniotomy, belonging to American Society of Anaesthesiologists (ASA) physical status I, II, or III. 3. Patients undergoing intraoperative pin fixation of the head. 4. Preoperative GCS 15 5. Patients with an anticipated full awakening from general anaesthesia within 2 hours postoperatively.
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. History of craniotomy with absent bone flap 2. Frontal craniotomy 3. Known psychiatric disorder 4. Uncontrolled epilepsy 5. Chronic headache. 6. Peri-incisional infection 7. No plan to extubate or expected prolonged mechanical ventilation. 8. Known allergy to NSAIDS, ketamine, or levobupivacaine. 9. Chronic opioid use ( >2 weeks) or history of excessive alcohol or drug abuse 10. Inability to understand the use of NRS. 11. Extremes of body mass index (BMI) ( 35 kg/cm2). 12. Pregnant or breastfeeding. Withdrawal criteria 1. Not awake 2 hours after surgery. 2. Early revision within the first 48 hours. 3. Voluntary withdrawal. 4. Received radiation therapy and chemotherapy postoperatively.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of our study will be time of first rescue analgesic administration from the time of test drug administration recorded as the pain-free interval. Timepoint: pain-free interval to be assessed | — |
Secondary
| Measure | Time frame |
|---|---|
| Cumulative dose of intraoperative opioids.Timepoint: duration of anesthesia;Cumulative dose of rescue analgesic requirement in the first 24 hours and 48 hours postoperative period.Timepoint: 24 hours postoperative period 48 hours postoperative period.;Postoperative nausea and vomiting (PONV) assessed at 2, 4, 8, 24, and 48 hours after surgeryTimepoint: 2, 4, 8, 24, and 48 hours after surgery;Postoperative pain scores assessed by NRS. The NRS scores will be recorded at 2, 4, 8, 12, 16, 20, 24, 36, and 48 h after surgery.Timepoint: 2, 4, 8, 12, 16, 20, 24, 36, and 48 h after surgery;Ramsay Sedation ScaleTimepoint: 2,4,8,24 and 48 hours after surgery | — |
Countries
India
Contacts
Public ContactNavneh Samagh
All India Institute of Medical Sciences, Bathinda
Outcome results
None listed