To study the pharmacological and physical effects of adding Fentanyl as an adjuvant to hyperbaric Bupivacaine in spinal anesthesia.

Recruiting

Conditions: Disease of appendix, unspecified, (2) ICD-10 Condition: K389||Disease of appendix, unspecified, (3) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, (4) ICD-10 Condition: K37||Unspecified appendicitis, (5) ICD-10 Condition: K37||Unspecified appendicitis, (6) ICD-10 Condition: K37||Unspecified appendicitis,

Registration Number: CTRI/2024/02/063359

Lead Sponsor: Mahatma Gandhi University of medical sciences and technology

Brief Summary: After getting clearance from Institute Ethics Committee and written informed consent of eligible patients, 90 patients aged 18-60 years, American Society of Anesthesiology grade I and II scheduled for elective lower abdominal surgeries will be enrolled in this study. On arrival patients will be connected to monitor and thereafter will be randomly allocated to three groups of 30 patients each. the investigator will remain blinded to the group allocation and the drug used. Patients in group A will receive 0.5% hyperbaric Bupivacaine 3.0 ml (12.5mg) in 5.0 ml syringe. Group B will receive 0.5% hyperbaric Bupivacaine 3.0 ml in a 5.0 ml syringe followed by 0.5 ml of normal saline in 1.0 ml syringe. Group C will receive 0.5% of hyperbaric Bupivacaine 3.0 ml in 5.0 ml syringe followed by 0.5 ml (25 microgram) of Fentanyl in 1.0 ml syringe.

Subarachnoid block will be administered at L 3-4 intervertebral space in lateral decubitus position.

onset of sensory block will be assessed by sterile pin prick every 2min till 20 mins and then after every 10 mins till highest level will be achieved. Sensory onset will be defined as the loss of sensation at T10 level and motor onset when modified Bromage score turns 3. Time of regression of moto blockade will be assessed by modified Bromage score becomes 0.

Vital parameters of the patients will be assessed periodically till completion of procedure. Time till the requirement of first rescue analgesia will be recorded. Entire data would be entered into Microsoft office software, appropriate statistical test will be applied and results will be calculated.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 90

Inclusion Criteria

1.Patients scheduled for elective below umbilical surgeries under subarachnoid block.
2.Patients of either sex between 18-55years of age 3.Patient under ASA CLASS I/ II 4.Patients willing to give written and informed consent.

Exclusion Criteria

1.Patient under ASA CLASS III, IV & V 2.HIV, HbsAg, HCV positive patients 3.Non-consenting patients.
4.Patients with Local site sepsis or any contraindication for subarachnoid block.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study the onset and duration of sensory and motor blockade, highest level of	minutes
anesthesia and total duration of analgesia with bupivacaine alone or when either	minutes
Fentanyl or saline is injected subsequent to Bupivacaine for spinal anesthesia.	minutes

Secondary Outcome Measures

Name	Time	Method
1.To study the changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), respiratory rate (RR), arterial oxygen saturation on pulse oximetry (SpO2).	2.To assess the requirement of postoperative rescue analgesia.

Trial Locations

Locations (1): Mahatma Gandhi cHospital
🇮🇳
Jaipur, RAJASTHAN, India
Mahatma Gandhi cHospital
🇮🇳Jaipur, RAJASTHAN, India
Dr Avnish Bharadwaj
Principal investigator
9314882845
avnishbharadwaj1@gmail.com