Comparatively studying the effect of addition of ketamine or magnesium sulphate when added to bupivacaine in scalp block for pain relief in head surgeries.

Completed

Conditions: Medical and Surgical,

Registration Number: CTRI/2021/12/038957

Lead Sponsor: AIIMS Rishikesh

Brief Summary: Neurosurgeries are associated with immense pain in patients, hence scalp block is given intraoperatively to decrease

the demand of analgesic drugs and to maintain hemodynamic stability. This analgesic activity of scalp block

can be enhanced by adding various additives with local aesthetics. Thus we compared the analgesic activity of

ketamine versus magnesium sulphate as adjuvant to bupivacaine for scalp block in patients undergoing

supratentorial craniotomies. It was double blind radomized comparative study. Total amount of drug in all the three

groups was 18ml. In group K patients were given scalp block using 12 ml 0.5 % bupivacaine with 2mg/kg ketamine. The total amount of drug taken was 18 ml and it was prepared by adding the normal saline for the remaining volume.In group M patients

were given scalp block using 12 ml 0.5 % bupivacaine with 250 mg of 10% magnesium sulphate and 3.5 ml of normal

saline, thus making total volume of 18 ml of drug.In group C patients were given scalp block using 12 ml of 0.5% bupivacaine, with 6 ml normal saline as placebo, thus making total volume of 18 ml of drug.We compared heart rate, mean blood pressure at various time points, analgesic requirements intraoperatively and postoperatively, the value of pain scores intraoperatively and postoperatively. On statistical analysis, further information about analgesic efficacy of scalp block in head surgery patients could be studied.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 102

Inclusion Criteria

ASA I-III patients in the age group mentioned above with Glasgow coma scale 13-15 who are scheduled for elective supratentorial craniotomies will be included in our study.

Exclusion Criteria

Below mentioned are our exclusion criteria: 1.
Refusal of consent.
Local infection at the injection site 3.
Patients with coagulation disorders/thrombocytopenia 4.
Patients having psychotic disorders/ substance abuse.
Patients with chronic headache or on analgesics for long duration.
Known or suspected allergy to study drugs.
Patients with uncontrolled hypertension, uncontrolled diabetes mellitus or heart disease.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Heart rate and mean arterial blood pressure following pin application in supratentorial craniotomies.	At 1 minute and 5 minutes following head pin application.

Secondary Outcome Measures

Name	Time	Method
Brain relaxation score following opening of dura mater.	At dura mater opening
Demand of first analgesic drug intraoperatively( more than 20% increase in heart rate and meaan blood pressure )	Time when heart rate and mean blood pressure increase by more than 20% for the first time intraoperatively
Perfusion index values intraoperatively and postoperatively	Baseline after shifting patient to operating table, 1 minute after induction of anesthesia, 5 minutes after induction of anesthesia, during scalp block, 1 minute after scalp block, 5 minutes after scalp block,during head pin application, 1 minute after head pin application, 5 minutes after head pin application,during incision, 1 minute after incision, 5 minutes after incision, every 30 minutes after incision until skin closure, during skin closure
Dose of rescue drug like propofol, fentanyl or beta blockers to treat hemodynamic fluctuations(heart rate and mean blood pressure change more than 20% of the baseline)	At any time point
Total analgesic consumption (opioid/ NSAIDS) intraoperatively and postoperatively up to 24 hours.	From entering in operating room upto 24 hours
Blood sugar levels till 24 hours postoperatively	Baseline after shifting patient to operating table, immediately following induction, 10 min after head pin insertion, end of surgery, at extubation, 2 hours post operatively and 24 hours post operatively
Critical-Care Pain Observation Tool (CPOT) score	1 hour postoperatively, 4 hours postoperatively, 8 hours postoperatively, 16 hours postoperatively and 24 hours postoperatively.
Time of demand for first analgesic drug postoperatively-extubated patients complain of pain and presence of CPOT2 in both extubated and ventilated patients	Time when patient needs analgesia for the first time in post operative period

Trial Locations

Locations (1): All India Institute of Medical Sciences
🇮🇳
Dehradun, UTTARANCHAL, India
All India Institute of Medical Sciences
🇮🇳Dehradun, UTTARANCHAL, India
Dr Sakshi
Principal investigator
9610058068
sakshi27wow@gmail.com