Comparison of drugs used for prolonging pain control under spinal anaesthesia

Comparison of post-operative Analgesic properties of Intrathecal Buprenorphine versus Midazolam as an Adjuvvant to 0.5% Hyperbaric Bupivacaine in Lower abdominal surgeries : A Randomized Double Blind interventional Controlled Study at SMS Medical College & attached Group of Hospitals, Jaipur during 2021-2023

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/05/042755

Enrollment

Registered

2022-05-23

Start date

Unknown

Completion date

Unknown

Last updated

2022-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Intrathecal Buprenoprphine: Group B- 4ml of a mixture containing 3ml of 0.5% hyperbaric Bupivacaine and 1 ml of Buprenorphine (60 mcg) for 60-90 mins Intervention2: Intrathecal Midazola

Eligibility

Inclusion criteria

Inclusion criteria: 1 Patients of either sex 2 Age group between 25 and 55 years 3 ASA grade I & II 4 Body weight 45 to 65 kg 5 Undergoing lower abdominal surgeries like Ovarian cystectomy, herniorraphy, abdominal hysterectomy. (Duration 60-90 min)

Exclusion criteria

Exclusion criteria: 1 Patients not willing to participate in the study 2 Cases with sepsis, bacteremia or skin infection of local site 3 History of severe hypovolemia, anemia and compromised renal, cardiac or respiratory status 4 Cases with raised intracranial tension 5 History of blood coagulopathies 6 Patient allergic to drugs used for study 7 Uncooperative patients 8 Failure of spinal anesthesia, cases in which general anaesthesia will be required

Design outcomes

Primary

Measure	Time frame
Mean time duration for the need of first rescue analgesiaTimepoint: At end of surgery then post-op 30 min ,60min 90min,120min,150min,180min,210min 4hr,6hr,8hr,12hr,24hr	—

Secondary

Measure	Time frame
â?¢ To assess and compare the onset time and duration of Sensory and Motor block. â?¢ To assess and compare Hemodynamic parameters: (Heart Rate; Mean Blood Pressure; Systolic Blood Pressure; Diastolic Blood Pressure), Sedation score and VAS score. â?¢ To find out and compare the proportion of cases with complications. Timepoint: At start of surgery then 5min,10min,15min,20min,25min,30min,40min,50min,60min,70min,80min,90min then end of surgery then post-op 30 min ,60min 90min,120min,150min,180min,210min 4hr,6hr,8hr,12hr,24hr	—

Measure

Time frame

â?¢ To assess and compare the onset time and duration of Sensory and Motor block. â?¢ To assess and compare Hemodynamic parameters: (Heart Rate; Mean Blood Pressure; Systolic Blood Pressure; Diastolic Blood Pressure), Sedation score and VAS score. â?¢ To find out and compare the proportion of cases with complications. Timepoint: At start of surgery then 5min,10min,15min,20min,25min,30min,40min,50min,60min,70min,80min,90min then end of surgery then post-op 30 min ,60min 90min,120min,150min,180min,210min 4hr,6hr,8hr,12hr,24hr

—

Countries

India

Contacts

Public ContactDr Samridhi Nanda

Sawai Man Singh Medical College

samridhinanda@gmail.com9680565399

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026