| CTRI Number |
CTRI/2025/02/081474 [Registered on: 28/02/2025] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the post operative analgesic effectiveness of bupivacaine-dexmedetomidine versus bupivacaine-fentanyl combination in thoracic epidural for midline laparotomies. |
|
Scientific Title of Study
|
Post Operative Analgesic Efficacy of Dexmedetomidine V/S fentanyl as an Adjuvant to Bupivacaine in Thoracic Epidural for Midline Laparotomies |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shikha Gupta |
| Designation |
PG 3rd year anaesthesia resident |
| Affiliation |
Sardar Patel Medical College |
| Address |
Department of anaesthesia, Sardar Patel Medical College, PBM Hospital, Bikaner, Rajasthan (334001)
Bikaner RAJASTHAN 334001 India |
| Phone |
8307568668 |
| Fax |
|
| Email |
Shikhashiv279@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Kiwi Mantan |
| Designation |
Associate Professor |
| Affiliation |
Sardar Patel Medical College |
| Address |
Department of anaesthesia, Sardar Patel Medical College, PBM Hospital, Bikaner, Rajasthan (334001)
Bikaner RAJASTHAN 334001 India |
| Phone |
9929092702 |
| Fax |
|
| Email |
kiwivyas@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Kiwi Mantan |
| Designation |
Associate Professor |
| Affiliation |
Sardar Patel Medical College |
| Address |
Department of anaesthesia, S.P. Medical College, Bikaner, Rajasthan 334001
Bikaner RAJASTHAN 334001 India |
| Phone |
9929092702 |
| Fax |
|
| Email |
kiwivyas@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sardar Patel Medical College, SP medical college road, Sardar Patel colony, Bikaner, Rajasthan 334001 |
|
|
Primary Sponsor
|
| Name |
Sardar Patel Medical College Bikaner Rajasthan |
| Address |
Department of Anaesthesia, Sardar Patel Medical College, Bikaner, Rajasthan |
| Type of Sponsor |
Government 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 Kiwi Mantan |
Sardar Patel Medical College |
Department of Anaesthesiology OT-A block PBM hospital, Sardar Patel Medical College, Bikaner Bikaner RAJASTHAN |
9929092702
kiwivyas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical and Research Board, Sardar Patel Medical College, Bikaner, Rajasthan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K631||Perforation of intestine (nontraumatic), (2) ICD-10 Condition: K566||Other and unspecified intestinal obstruction, (3) ICD-10 Condition: K46||Unspecified abdominal hernia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Post operative analgesic efficacy of dexmedetomidine versus fentanyl as an adjuvant to bupivacaine in thoracic epidural for midline laparotomies |
Under all aseptic conditions, an epidural catheter was inserted via 16 G or 18 G Toheys needle using LOR technique and secured at the level of T8-T9, T9-T10 or T10-T11 interspace in the patients posted for midline laparotomies. A combination of 10 mL of 0.25% bupivacaine with 0.5 mL of dexmedetomidine (50 mcg) and 0.5 mL of 0.9% NS was given epidurally in one group of patients. In another group of patients, a combination of 10 ml of 0.25% bupivacaine with 1 ml of fentanyl (50 mcg) was given via epidural route. Both the drugs were given epidurally within 10 minutes of intubation. Duration of post operative analgesia was assessed using numerical rating scale. |
| Intervention |
Thoracic epidural for post operative analgesic efficacy in midline laparotomies |
Under all aseptic conditions, an epidural catheter was inserted via 16 G or 18 G Toheys needle using LOR technique and secured at the level of T8-T9, T9-T10 or T10-T11 interspace in midline laparotomies. Study drug was given via epidural route within 10 minutes of intubation. Duration of post operative analgesia was assessed using Numerical Rating Scale. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients in age group 18-70 years. 2. Posted for elective laparotomy. 3. BMI 18-30 Kg/m2. 4. ASA grade I, II, III. |
|
| ExclusionCriteria |
| Details |
1. Patient refusal. 2. Known allergy to drug used in the study. 3. Patient with ASA grade IV and above. 4. Pre-existing intrinsic or idiopathic coagulopathy. 5. Hepatic, renal or cardiorespiratory failure. 6. Patients with an increase in intracranial pressure.
7. Skin or soft tissue infection at the proposed site of needle insertion.
8. Severe hypovolemia.
9. Pre-existing neurological disease.
10. Emergency laparotomy surgeries.
11. Surgeries lasting for more than 3 hrs. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare dexmedetomidine and fentanyl as an adjuvant for bupivacaine in thoracic epidural in terms of duration of post operative analgesia in first 24 hours. |
Evaluate on the basis of NRS score at different intervals in first 24 hours 30 mins, 1 hour, 2 hours, 3 hours, 6 hours, 9 hours, 12 hours, 18 hours and 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Peri-operative hemodynamic stability
2. Post-operative sedation score
3. Side effects and complications related to drugs and procedure. |
1. Intra-operative heart rate, SBP, DBP, MAP, spO2 before intubation, thoracic epidural analgesic given(T0), 5 min, 10 min, 15 min, 30 min, 1 hour, 1 hour 30 min, 2 hours, 2 hour 30 min, 3 hours, immediate post intubation.
2. Post operative heart rate, SBP, DBP, MAP, spO2 in the first 24 hours 30 mins, 1 hour, 2 hours, 3 hours, 6 hours, 9 hours, 12 hours, 18 hours and 24 hours.
3. Post operative sedation score in first 24 hours 30 mins, 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours. |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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 4 |
|
Date of First Enrollment (India)
|
10/03/2025 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Large surgical incisions and extensive gut
handling and manipulation are involved with upper abdominal surgeries which
increases the need for perioperative analgesia. Uncontrolled postoperative pain
and pathophysiological response to surgery make these patients prone to high
stress and sympathetic activation. Epidural analgesia is a simple and safe technique that produces
effective block with small dose of local anaesthetic. It provides extended post-operative pain control that is superior to that provided by systemic opioids alone.
Thoracic epidural analgesia (TEA) provides good postoperative pain relief and
facilitates deep breathing exercises and early ambulation. Sympathetic outflow
decreases with use of TEA. To achieve desired post-op analgesic effect, invariably large
volumes of local anaesthetics are used, thereby increasing the possibilities of
local anaesthetic toxicity and deleterious hemodynamic consequences. Opioids
like fentanyl have been used traditionally as an adjunct for epidural
administration in combination with a lower dose of local anaesthetic to achieve
the desired analgesic effect. The addition of opioid does provide a dose sparing
effect of local anaesthetic and superior analgesia but there is always a possibility
of an increased incidence of nausea, vomiting and
respiratory depression. Dexmedetomidine is an alpha-2 agonist which
has got numerous beneficial effects. It acts on
both pre and post synaptic sympathetic nerve terminal and central nervous
system thereby decreasing the sympathetic outflow and nor-epinephrine release.
Dexmedetomidine has an effective sedative, anti-anxiety and analgesic effect.
Dexmedetomidine does cause a manageable hypotension and bradycardia but it does not cause opioid related side effects like
respiratory depression, nausea and vomiting. Therefore, we planned to compare the post operative analgesic efficacy of
dexmedetomidine vs fentanyl as an adjuvant to bupivacaine in thoracic epidural
for midline laparotomies. |