CTRI/2025/09/094389Not yet recruitingPhase 4
Comparative study of intrathecal hyperbaric bupivacaine 0.5 percentage with fentanyl versus buprenorphine in lower limb surgeries in tertiary care centre
ACS MEDICAL COLLEGE AND HOSPITAL1 site in 1 country76 target enrollmentStarted: January 5, 2026Last updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- TO NOTE THE EFFECTIVENESS OF INTRATHECAL FENTANYL ,BUPRENORPHINE AND BUPIVACAINEON CHARACTERISTICS OF SUBARACHNOID BLOCK
Study Overview
Brief Summary
i randomised patients undergoing lower limb surgeries under spinal anaesthesia into two groups so as to receive intrathecal either buprenorphine and fentanyl and bupivacaine 0.5% hyperbaric and noted study parameters in equal periods of time
benefits of participation intrathecal buprenorphine produces a more preferable prolonged sensory block and motor block than fentanyl and both groups hemodynamic stability was equal
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •ASA1 and ASA2 PATIENTS ALL PATIENTS UNDERGOING ELECTIVE LOWER LIMB SURGERY UNDER SPINAL ANAESTHESIA PATIENT BELONGING TO AGE GROUP 18-60 YEARS.
Exclusion Criteria
- •ASA PHYSICAL STATUS MORE THAN ASA3 and ASA4 HISTORY OF ALLERGY TO FENTANYL,BUPRENORPHINE AND BUPIVACAINE PATIENTS REFUSAL PATIENT HAVING CONTRAINDICATIONS TO SPINAL ANAESTHESIA PATIENT WITH HISTORY OF BLEEDING DISORDERS OR PATIENTS ON ANTICOAGULANTS PATIENTS WITH INFECTION AT THE SITE OF INJECTION PATIENT WITH INFECTION AT THE SITE OF INJECTION PATIENTS WITH ALLERGY TO LOCAL ANAESTHETICS PATIENTS WITH CARDIAC DISEASE,HEART BLOCK ,DYSRHYTHMIAS , ANEMIA,SEVERE HYPOVOLEMIA,SHOCK,SEPTICEMIA,AND NEUROLOGICAL DEFECTS PATIENTS ON BETA BLOCKERS AND ALPHA BLOCKERS ANATOMICAL ABNORMALITY AT THE REGIONAL SITE PREGNANT WOMEN.
Outcomes
Primary Outcomes
TO NOTE THE EFFECTIVENESS OF INTRATHECAL FENTANYL ,BUPRENORPHINE AND BUPIVACAINEON CHARACTERISTICS OF SUBARACHNOID BLOCK
Time Frame: TO NOTE THE EFFECTIVENESS OF INTRATHECAL FENTANYL ,BUPRENORPHINE AND BUPIVACAINEON CHARACTERISTICS OF SUBARACHNOID BLOCK AT THE TIME OF 1ST ONSET OF PAIN
Secondary Outcomes
- TO STUDY THE DURATION OF POSTOPERATIVE ANALGESIA AS TIME FOR THE FIRST ONSET OF PAIN AND TO STUDY EFFECTS OF HEMODYNAMIC PARAMETERS AND VITALS PARAMETERS(AT TIME OF 1ST ONSET OF PAIN)
Investigators
DR ANNAPOORANI MANOHAR
ACS MEDICAL COLLEGE & HOSPITAL
Study Sites (1)
Loading locations...
Similar Trials
Not yet recruiting
Phase 4
Better drug for Caesarean sectionCTRI/2025/02/080677Government medical College Baroda116
Not yet recruiting
Phase 2/3
Comparison of intrathecal bupivacaine with dexmedetomidine versus intrathecal levobupivacaine with dexmedetomidine for lower limb and lower abdominal surgeriesCTRI/2025/11/097003sapthagiri institute of medical science and research center62
Not yet recruiting
Phase 4
Comparison Of Intravenous And Intrathecal Magnesium Sulphate with Spinal anaesthesia in patients undergoing lower abdominal elective surgery to study onset and duration of numbness,pain relief and stability of blood pressure and heart rate.CTRI/2025/09/094977135
Not yet recruiting
Phase 1
Compare Hemodynamic Profile Of Intrathecal Hyperbaric Bupivacaine 0.5 percent Versus Hyperbaric Levobupivacaine 0.5 percent in Elderly Population Undergoing Infraumbilical SurgeriesCTRI/2025/09/093955Bharati Hospital and Research Centre, Pune90
Not yet recruiting
Phase 2
Comparison of Hypotension After Spinal Anesthesia With Hyperbaric Vs Isobaric Bupivacaine in Elective Cesarean After Colloid Preloading.NCT07416084Liaquat National Hospital & Medical College60