To study the effect of addition of adjuvants- buprenorphine vs nalbuphine , to ropivacaine for giving spinal anaesthesia in below umbilicus surgeries

EFFECT OF ADDITION OF BUPRENORPHINE VS NALBUPHINE TO 0.75 PERCENT HYPERBARIC ROPIVACAINE FOR THE SUBARACHNOID BLOCK IN INFRA-UMBILICAL SURGERIES - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/093761

Enrollment

105

Registered

2025-08-27

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

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: Subarachnoid block / spinal anaesthesia: To see effect of addition of intrathecal buprenorphine vs nalbuphine to hyperbaric 0.75 percent ropivacaine ,on duration of analgesia , motor an

for subarachnoid block in infra-umblical surgeries. To compare their effects on analgesia, sensory and motor blockade, hemodymanic parameters . Total duration of study - 18 months

Eligibility

Inclusion criteria

Inclusion criteria: ASA grade I and II patients of all genders Patients posted for elective surgeries below umbilicus.

Exclusion criteria

Exclusion criteria: Contraindications to spinal anaesthesia (coagulopathy, local infection, severe hypovolemia) History of allergy to study medications Significant cardiovascular, respiratory, renal, or hepatic dysfunction Pregnancy or lactation Patients on chronic analgesic therapy Patients with psychiatric disorders

Design outcomes

Primary

Measure	Time frame
To compare the characteristics of sensory and motor blockade as well as the total duration of effective analgesia across all three groups.Timepoint: T0- 15min T1- 30 min T2-45 min T3-60 min	—

Secondary

Measure	Time frame
1. Hemodynamic parameters (SBP, DBP, MAP, HR, SPO2 & RR) at baseline & at 5, 10, 15, 30, 60, 90, & 120 minutes after spinal anaesthesia. Timepoint: Baseline After preloading After SAB 2 min 5 min 10 min;Sedation score using Ramsay sedation scale.Timepoint: Time Sedation Score Baseline 15 min 30 min 60 min 90 min 120 min End of surgery;Incidence of side effects like nausea & vomiting (PONV), pruritus, respiratory depression, hypotension, bradycardia.Timepoint: During perioperative period;Patient satisfaction score on a 5-point Likert scale (1=very dissatisfied, 5=very satisfied) using a specially designed questionnaire.Timepoint: Are you satisfied with Pre Anaesthetic Checkup visit? 1 Very Dissatisfied 2 Dissatisfied 3 - Neutral 4 Satisfied 5 Very Satisfied 2. Was the advice given for pre-op preparation adequate ? 1 Very Dissatisfied 2 Dissatisfied 3 - Neutral 4 Satisfied 5 Very Satisfied 3. What was your experience in intra-op period (the spinal anaesthesia experience)? 1 Very Dissatisfied 2 Dissatisfied 3 - Neutral 4 Satisfied 5 Very Satisfied 4. Was the pain relief adequate in immediate post-op period ? 1 Very Dissatisfied 2 Dissatisfied 3 - Neutral 4 Satisfied 5 Very Satisfied 5. What was your overall experience ? 1 Very Dissatisfied 2 Dissatisfied 3 - Neutral 4 Satisfied 5 Very Satisfied	—

Measure

Time frame

1. Hemodynamic parameters (SBP, DBP, MAP, HR, SPO2 & RR) at baseline & at 5, 10, 15, 30, 60, 90, & 120 minutes after spinal anaesthesia. Timepoint: Baseline After preloading After SAB 2 min 5 min 10 min;Sedation score using Ramsay sedation scale.Timepoint: Time Sedation Score Baseline 15 min 30 min 60 min 90 min 120 min End of surgery;Incidence of side effects like nausea & vomiting (PONV), pruritus, respiratory depression, hypotension, bradycardia.Timepoint: During perioperative period;Patient satisfaction score on a 5-point Likert scale (1=very dissatisfied, 5=very satisfied) using a specially designed questionnaire.Timepoint: Are you satisfied with Pre Anaesthetic Checkup visit? 1 Very Dissatisfied 2 Dissatisfied 3 - Neutral 4 Satisfied 5 Very Satisfied 2. Was the advice given for pre-op preparation adequate ? 1 Very Dissatisfied 2 Dissatisfied 3 - Neutral 4 Satisfied 5 Very Satisfied 3. What was your experience in intra-op period (the spinal anaesthesia experience)? 1 Very Dissatisfied 2 Dissatisfied 3 - Neutral 4 Satisfied 5 Very Satisfied 4. Was the pain relief adequate in immediate post-op period ? 1 Very Dissatisfied 2 Dissatisfied 3 - Neutral 4 Satisfied 5 Very Satisfied 5. What was your overall experience ? 1 Very Dissatisfied 2 Dissatisfied 3 - Neutral 4 Satisfied 5 Very Satisfied

—

Countries

India

Contacts

Public ContactDr Mridul Madhav Panditrao

Adesh Institute of Medical sciences and Research(AIMSR), Bathinda

drmmprao1@gmail.com8699921884

Outcome results

None listed

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