| CTRI Number |
CTRI/2026/02/105056 [Registered on: 27/02/2026] Trial Registered Prospectively |
| Last Modified On: |
24/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Which drug works better for pain relief after a Caesarean section dexmedetomidine or dexamethasone when added to a numbing medicine called levobupivacaine using an ultrasound guided injection |
|
Scientific Title of Study
|
Comparative study on efficacy of ultrasound guided transversus abdominis plane block using dexmedetomidine versus dexamethasone as adjuvant to levobupivacaine for post-operative analgesia following caesarean section under sub arachnoid block. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arjika Saklani |
| Designation |
PG Resident |
| Affiliation |
School of Medical Sciences and Research Sharda University |
| Address |
Department of Anaesthesiology School of Medical Sciences and
Research Sharda University Greater Noida Gautam Buddha Nagar
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9953092719 |
| Fax |
|
| Email |
arjika.saklani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shiv Kumar Singh |
| Designation |
Professor |
| Affiliation |
School of Medical Sciences and Research Sharda University |
| Address |
Department of Anaesthesiology School of Medical Sciences and
Research Sharda University Greater Noida Gautam Buddha Nagar
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9650943359 |
| Fax |
|
| Email |
shiv.singh@sharda.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Shiv Kumar Singh |
| Designation |
Professor |
| Affiliation |
School of Medical Sciences and Research Sharda University |
| Address |
Department of Anaesthesiology School of Medical Sciences and
Research Sharda University Greater Noida Gautam Buddha Nagar
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9650943359 |
| Fax |
|
| Email |
shiv.singh@sharda.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
School of Medical Sciences and Research Sharda University |
| Address |
Department of Anaesthesiology, School of Medical Sciences and Research, Sharda University,
Greater Noida, Gautam Buddha Nagar, Uttar Pradesh 201306
|
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arjika Saklani |
School of Medical Sciences and Research Sharda Hospital |
Block 2F Department of
Anaesthesiology Sharda
University Knowledge
Park III Greater Noida
Gautam Buddha Nagar
Uttar Pradesh India
Gautam Buddha Nagar
UTTAR PRADESH
Gautam Buddha Nagar
UTTAR PRADESH |
9953092719
arjika.saklani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparative study on efficacy of ultrasound guided transversus abdominis plane block using dexmedetomidine versus dexamethasone as adjuvant to levobupivacaine for post-operative analgesia following caesarean section under sub arachnoid block |
Two groups are taken with a total sample size of 58.The aim would be to assess and compare efficacy of post operative pain relief in both groups. Group 1- Patients will receive a local anesthetic solution consisting of 40 mL of 0.125% (1.25mg/ml) levobupivacaine and 8 mg of dexamethasone. It will be equally distributed bilaterally in the TAP block.Group 2- Patients will receive a mixture of 40 mL of 0.125% (1.25mg/ml) levobupivacaine and dexmedetomidine with a total dose of 0.5 µg/kg body weight. It will be equally distributed bilaterally in the TAP block. Post operatively patient will be monitored for following-
1.To record the duration of post operative analgesia of block which is determined by time to first additional rescue analgesic administration.
2. Total amount of additional analgesic consumption.
3.To study side effects like nausea and vomiting and sedation |
| Intervention |
Transversus abdominis plane block |
After cesarean section TAP block will be given using ultrasonography after the closure of the skin. A high frequency linear probe (6-13 MHz) will be used to give block at triangle of petites in supine position bilaterally under all aseptic measures. The linear array ultrasound probe will be positioned at the level of the umbilicus on the anterolateral abdominal wall, between the subcostal edge and the iliac crest. The transversus abdominis muscle (TA) , internal oblique muscle (IO), and external oblique muscles (EO) will be recognized. The IO and TA muscles form a hypoechoic line that points to the fascial plane. Under ultrasound guidance and after confirming a negative aspiration result, a local anaesthetic solution combination will be administered using a 25 gauge 10 cm long Sonoplex needle.
Two groups are taken with a total sample size of 58.The aim would be to assess and compare efficacy of post operative pain relief in both groups. Group 1- Patients will receive a local anesthetic solution consisting of 40 mL of 0.125% (1.25mg/ml) levobupivacaine and 8 mg of dexamethasone. It will be equally distributed bilaterally in the TAP block.Group 2- Patients will receive a mixture of 40 mL of 0.125% (1.25mg/ml) levobupivacaine and dexmedetomidine with a total dose of 0.5 µg/kg body weight.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.ASA 2
2.Age 18 years to 45 years.
3.BMI less than or equal to 30
4.Patients able to understand and rate their pain in Visual Analogue Score
|
|
| ExclusionCriteria |
| Details |
1.Coagulopathy or patients on anticoagulation therapy.
2.History of allergy to Levobupivacaine, dexmedetomidine and dexamethasone.
3.Infection at the site of injection.
4.History of psychiatric illness.
5.History of significant heart disease, liver disease, renal disease, hypertension and diabetes mellitus.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare efficacy of post operative pain relief in both groups. |
Till 24 hours post operative period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To record the duration of post operative analgesia of block which is determined by time to first additional rescue analgesic administration.
Total amount of additional analgesic consumption.
To study side effects like nausea and vomiting and sedation. |
Till 24 hours post operative period. |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
13/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Ceasarean section is a common surgical procedure performed to deliver a baby when a vaginal delivery is not possible. Post operative pain management after a cesarean section is crucial for both mother and baby.The management of postoperative pain in caesarean section is often approached using multimodal analgesia, incorporating both pharmacological and non-pharmacological strategies. One such strategy is the use of regional anaesthesia techniques, such as the Transversus Abdominis Plane (TAP) block, which has been shown to provide effective analgesia by blocking sensory innervation to the anterior abdominal wall. When combined with adjuvants like dexamethasone and dexmedetomidine, the efficacy of the TAP block may be enhanced, providing prolonged and more effective pain relief. The TAP block targets the T6-L1 spinal nerves, which provide sensory innervation to the anterior abdominal wall, including the skin and muscles. By blocking pain signals from the surgical site, the TAP block helps reduce the need for systemic opioids, thus mitigating the side effects associated with their use, such as nausea, vomiting, and constipation. It is a relatively simple, minimally invasive procedure with a low risk of complications when performed correctly. The aim of the study is to compare on efficacy of ultrasound guided transversus abdominis plane block using dexmedetomidine or dexamethasone as adjuvant to levobupivacaine for post-operative analgesia following caesarean section under sub arachnoid block. Objectives Primary To assess and compare efficacy of post operative pain relief in both groups. Secondary 1. To record the duration of post operative analgesia of block which is determined by time to first additional rescue analgesic administration. 2. Total amount of additional analgesic consumption. 3. To study side effects like nausea and vomiting and sedation.
Study Groups .Subjects will be divided into two study groups. Group 1.Patients will receive a local anesthetic solution consisting of 40 mL of 0.125% (1.25mg/ml) levobupivacaine and 8 mg of dexamethasone. It will be equally distributed bilaterally in the TAP block
Group 2. Patients will receive a mixture of 40 mL of 0.125% (1.25mg/ml) levobupivacaine and dexmedetomidine with a total dose of 0.5 µg/kg body weight. It will be equally distributed bilaterally in the TAP block.
Subarachnoid block will be given at either L3-L4 or L4-L5 inter-vertebral spaces where 2-2.5ml (i.e. 5mg/ml) of hyperbaric bupivacaine will be injected using 25-gauge Quincke spinal needle. After surgery TAP block is will be given using ultrasonography after the closure of the skin. A high frequency linear probe (6-13 MHz) will be used to give block at triangle of petites in supine position bilaterally under all aseptic measures. The linear array ultrasound probe will be positioned at the level of the umbilicus on the anterolateral abdominal wall, between the subcostal edge and the iliac crest. The transversus abdominis muscle (TA) , internal oblique muscle (IO), and external oblique muscles (EO) will be recognized. The IO and TA muscles form a hypoechoic line that points to the fascial plane. Under ultrasound guidance and after confirming a negative aspiration result, a local anaesthetic solution combination will be administered using a 25-gauge 10 cm long Sono-plex needle. In this study, postoperative pain will be evaluated in both groups using the VAS (Visual Analog Scale).Time of first dose of rescue analgesia consumption will be recorded and total analgesic consumption will be recorded in the first 24 hours after surgery.
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