A study to analyse and compare the pain-relieving properties of two different spinal anaesthesia drug combinations in pregnant women undergoing planned lower segment caesarean section, to identify the most suitable combination for safe and effective pain relief.

Evaluation and comparison of analgesic property of intrathecal hyperbaric bupivacaine with dexmedetomidine versus hyperbaric bupivacaine with fentanyl in elective LSCS. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/101205

Enrollment

Registered

2026-01-15

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

None listed

Interventions

Intervention1: Intrathecal Hyperbaric Bupivacaine with Dexmedetomidine: Intrathecal Hyperbaric Bupivacaine 10 mg (2 ml) + Dexmedetomidine 5 mcg (0.3 ml) for total duration of 18 months or 1 year and 6

Eligibility

Inclusion criteria

Inclusion criteria: 1.Pregnant females posted for LSCS under spinal anaesthesia, giving written consent 2.Pregnant females with ASA class II 3.Age between 18 to 45 years 4.Gestational period more than or equal to 37 weeks less than 42 weeks 5.Uncomplicated singleton pregnancy

Exclusion criteria

Exclusion criteria: 1.Pregnant females with any comorbidities like, Diabetes Mellitus, Hypertension, Seizure Disorder, Thyroid Disease, and other chronic diseases 2.Serious pregnancy complications like Haemorrhage, Pregnancy Induced Hypertension, Congestive Cardiac Failure, Severe or Marked Anaemia, type 1 and 2 Diabetes Mellitus with complications and any Bleeding disorder 3.Preoperative maternal heart rate less than 60 beats per min, with conduction and rhythm problems 4.Any established foetal anomalies and foetal distress 5.Hypersensitivity to medicines to be utilized in the study 6.ASA physical status of class III and IV

Design outcomes

Primary

Measure	Time frame
To evaluate and compare the analgesic efficacy of Intrathecal Hyperbaric Bupivacaine with Dexmedetomidine versus Intrathecal Hyperbaric Bupivacaine with Fentanyl, we will assess and compare the duration of Analgesia.Timepoint: The duration or length of spinal analgesia will be the time interval from the intrathecal injection to the first time the patient requires rescue analgesia. it will be assessed by Visual Analogue Scale (VAS) at first rescue analgesia, ranging from 0 to 10 scores. [Rescue analgesia - injection Diclofenac sodium 75 mg intravenously, if the Visual analogue Scale (VAS) score is equal to or greater than 3(means mild pain)].	—

Measure

Time frame

To evaluate and compare the analgesic efficacy of Intrathecal Hyperbaric Bupivacaine with Dexmedetomidine versus Intrathecal Hyperbaric Bupivacaine with Fentanyl, we will assess and compare the duration of Analgesia.Timepoint: The duration or length of spinal analgesia will be the time interval from the intrathecal injection to the first time the patient requires rescue analgesia. it will be assessed by Visual Analogue Scale (VAS) at first rescue analgesia, ranging from 0 to 10 scores. [Rescue analgesia - injection Diclofenac sodium 75 mg intravenously, if the Visual analogue Scale (VAS) score is equal to or greater than 3(means mild pain)].

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Secondary

Measure	Time frame
1. Level of block achieved, both sensory & motor 2. Speed of onset of the desired level of block (minimum time taken) 3. Rate of level regression (regression time to T10) 4. Need for other intravenous analgesia / GA in case of prolongation of surgery 5. To study any adverse effects like bradycardia, hypotension, & shivering 6. To study the Neonatal APGAR ScoreTimepoint: Sensory block will be evaluated by a blunt pinprick at every minute till the block level is achieved. Assessment of Motor block - The time; from intrathecal injection to the inability of the patient to move her legs, will be taken as time for motor block. The timespan for two-segment regression level of sensory block will be checked every 30 min after giving spinal anaesthesia. Apgar scores will be noted at 1- & 5- minutes after the birth.	—

Measure

Time frame

1. Level of block achieved, both sensory & motor 2. Speed of onset of the desired level of block (minimum time taken) 3. Rate of level regression (regression time to T10) 4. Need for other intravenous analgesia / GA in case of prolongation of surgery 5. To study any adverse effects like bradycardia, hypotension, & shivering 6. To study the Neonatal APGAR ScoreTimepoint: Sensory block will be evaluated by a blunt pinprick at every minute till the block level is achieved. Assessment of Motor block - The time; from intrathecal injection to the inability of the patient to move her legs, will be taken as time for motor block. The timespan for two-segment regression level of sensory block will be checked every 30 min after giving spinal anaesthesia. Apgar scores will be noted at 1- & 5- minutes after the birth.

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Countries

India

Contacts

Public ContactDr Arti Sharma

Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan, Himachal Pradesh, India.

aartisharma309@gmail.com8219189886

Outcome results