| CTRI Number |
CTRI/2024/10/074603 [Registered on: 01/10/2024] Trial Registered Prospectively |
| Last Modified On: |
29/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Comparing the effect of the drugs Levobupivacaine with Fentanyl versus Levobupivacaine with Demedetomidine in patients undergoing caesarean section under spinal anaesthesia |
|
Scientific Title of Study
|
Efficacy of intrathecal Levobupivacaine with Fentanyl vs Levobupivacaine with Dexmedetomidine in patients undergoing LSCS: A prospective hospital based study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Addhavan R S |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Anaesthesiology, KLES Dr Prabhakar Kore Hospital and Medical Research Centre, Jawaharlal Nehru Medical College campus, Nehru Nagar, Belagavi
Belgaum KARNATAKA 590010 India |
| Phone |
9342318177 |
| Fax |
|
| Email |
adhavanram16@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Kedareshvara K S |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Anaesthesiology, KLES Dr Prabhakar Kore Hospital and Medical Research Centre, Jawaharlal Nehru Medical College campus, Nehru Nagar, Belagavi
Belgaum KARNATAKA 590010 India |
| Phone |
9886375154 |
| Fax |
|
| Email |
kedareshvara@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Addhavan R S |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Anaesthesiology, KLES Dr Prabhakar Kore Hospital and Medical Research Centre, Jawaharlal Nehru Medical College campus, Nehru Nagar, Belagavi
Belgaum KARNATAKA 590010 India |
| Phone |
9342318177 |
| Fax |
|
| Email |
adhavanram16@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLES Dr Prabhakar Kore Hospital and Medical Research Centre, Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi, Karnataka. India. Pincode-590010 |
|
|
Primary Sponsor
|
| Name |
Addhavan R S |
| Address |
Department of Anaesthesiology, KLES Dr Prabhakar Kore Hospital and Medical Research Centre, Jawaharlal Nehru Medical College campus, Nehru Nagar, Belagavi, Karnataka |
| Type of Sponsor |
Other [Self] |
|
|
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 Addhavan R S |
KLES Dr Prabhakar Kore Hospital and Medical Research Centre |
Department of Anaesthesiology, KLES Dr Prabhakar Kore Hospital and Medical Research Centre, Jawaharlal Nehru Medical College campus, Nehru Nagar, Belagavi, Karnataka Belgaum KARNATAKA |
9342318177
adhavanram16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee, Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi-590010 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Levobupivacaine with fentanyl |
Patient receiving intrathecal hyperbaric levobupivacaine of 2.1 ml plus 25mcg(0.5ml) of fentanyl a total of 2.6ml |
| Comparator Agent |
Levobupivacine with dexmedetomidine |
Patient receiving intrathecal hyperbaric levobupivacine of 2.1 ml plus 5 mcg(0.05ml) of dexmedetomidine plus 0.45ml of distilled water a total of 2.6ml. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
ASA grade 1 and 2
Age between 18 to 40 years
Height 150 TO 175 cms
Weight 45 TO 80 kg |
|
| ExclusionCriteria |
| Details |
Coagulation disorders
Foetal distress
Patients with gestational hypertension
Patient refusal |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the onset, duration of sensory and motor block and requirement of rescue analgesia for patients undergoing caesarean section under spinal anaesthesia with intrathecal fentanyl or dexmedetomidine with levobupivacine(H) |
0 min, 1 min, 2 mins and after 4 to 6 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the haemodynamic parameters such as heart rate, non-invasive blood pressure, SpO2 between both the drugs |
Baseline (0 mins), 1 mins, 3 mins, 5 mins, 10 mins, 15 mins,20 mins,25 mins,30 mins,35 mins,40 mins,45 mins,50 mins,55 mins,60 mins |
|
|
Target Sample Size
|
Total Sample Size="96" Sample Size from India="96"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
11/10/2024 |
| 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
|
Spinal
anaesthesia is the most commonly performed anaesthetic technique for caesarean
section .At first lidocaine 5% was used as local anaesthetic for lscs
procedure, it usage has decreased because it caused transient neurologic
symptoms. After that Bupivacine 0.5% hyperbaric was used and it also has
increased the duration of motor block. So Intrathecal local anesthetics alone
are not enough for effective postoperative analgesia and higher doses of local
anaesthetics are also associated with hemodynamic instability, which can lead
to unfavorable maternal and fetal outcome. So far many adjuncts have been used
to prolong the analgesia produced by intrathecal LA and to reduce their adverse
effects. They are fentanyl, ketamine, dexmedetomidine,
clonidine, buprenorphine midazolam and etc.
After that a new drug a levobupivacine
plain was used as a local anaesthetic for caesarean section and other lower
limb surgeries as it has better sensory blockade and faster regression of motor
blockade compared to bupivacaine.The very latest addition to local anaesthetic
used for lscs is hyperbaric levobupivacaine, which is the s enantiomer of
bupivacaine and was introduced recently. Levobupivacaine seems identical to
bupivacaine in potency and shows longer duration of action on neural tissue.Hyperbaric
levobupivacaine has less cardiotoxicity propensity and less chance of cephalic
spread, which favor particularly in LSCS. In the postoperative period
prolonging the analgesia is the best way to encourage for early ambulation of
patients.
Fentanyl is a lipophilic μ-receptor agonist
opioid. Intrathecally, fentanyl exerts its effect by combining with opioid
receptors in the dorsal horn of spinal cord and may have a supra spinal spread
and action . It has been well documented that a combination of fentanyl with
local anaesthetic has prolonged the sensory blockade without intensifying motor
blockade.
Dexmedetomidine is a highly selective
α2–adrenoceptor agonist, and recently used as an adjuvant with intrathecal local
anaesthetic and found to prolong the duration of sensory and motor blockade as
well as to provide hemodynamic stability during intraoperative period. It also
produces dose dependent sedation, anxiolysis and analgesia (involving spinal
and supraspinal sites) without respiratory depression.
Dexmedetomidine is a potent alpha 2 adregenic
agonist with a half life of 2 to 3 hrs and it undergoes hepatic metabolism and
excreted by kidneys. It has dose dependent action. Adverse effects are hypotension
and bradycardia. Fentanyl is metabolized by N-demethylation and excreted by
kidneys. Its half life is 3 to 6 hrs. Adverse are effects respiratory
suppression, bradycardia , hypotension, pruritis and it should be avoided in
head injury patients.
Till now studies have been conducted by
using isobaric levobupivacine. But now recently hyperbaric levobupivacine is
available and we are conducting a study by using hyperbaric levobupivacine.
The primary objective of the study is to compare the onset and duration of motor and sensory block and requirement of rescue analgesia for patients undergoing caesarean section under spinal anaesthesia with intrathecal fentanyl or dexmedetomiine with levobupivacaine(H)
The secondary objective of the study is to compare the haemodynamic parameters such as heart rate,
non-invasive blood pressure, SpO2 between both the drugs. Patient fullfilling the eligibility criteria will be assigned to one of two groups. GROUP F : Patient receiving hyperbaric
levobupivacine of 2.1 ml plus 0.5ml of 25mcg of fentanyl so total volume of
2.6ml .
GROUP D : Patient receiving hyperbaric levobupivacine of 2.1 ml plus
0.05ml 5mcg of dexmedetomidine plus 0.45ml of distilled water so total volume
of 2.6ml Assigning
of patients into two groups was performed by anesthesiologist involved in drug
preparations. Other investigator involved in the procedure and monitoring was
unaware of group allocation. Patients were also blinded to the drug regimen
used in spinal anesthesia. On arrival to operating room, baseline parameters
recorded. Peripheral 18G cannula secured and preloading done with lactated
ringer solution 10 ml/kg. Before spinal anesthesia patients were explained
about the procedure and methodology of monitoring methods. In sitting position
under strict aseptic precautions, using a midline approach lumbar puncture was
performed at L3-L4 intervertebral space by 25G Quincke spinal needle. After
confirming the free flow of cerebrospinal fluid, the studied drug solution was
injected intrathecally and patients were made into supine position. Primary
outcome is to determine time taken to achieve motor
block and sensory block that is the duration of time taken from time of giving
spinal to the onset of action of drug to produce motor and sensory block ,Duration
of motor block and sensory block is that time taken from the onset of block to
time when the spinal wares off and Duration of analgesia is that when the
patient feels the pain and next dose of analgesic is started.Secondary outcome was to compare the hemodynamic
parameters such as heart rate , blood pressure and spo2. The level of sensory block
assessed, by pinprick test or cold test and dermatomes levels were tested until
the highest level had stabilized by consecutive tests. The motor dermatome
level was assessed using Modified Bromage scale. Bromage 0 – full flexion of
knees and feet, Bromage 1 – just able to move knees, Bromage 2 – able to move
feet only, Bromage 3 – unable to move feet and knees[14]. The time
to reach Bromage scale 3 before surgery and Bromage 0 in post anesthesia care
unit (PACU) was recorded. On achieving sensory and motor blockade and Bromage
scale 3 surgery was allowed. Pain was assessed using Visual Analog Score VAS (0
to 10) scale at time of incision and at completion of surgery. VAS 0 – No pain
, VAS 1 to 2 – least pain , VAS 3 to 4 – mild pain , VAS 5 to 6 – moderate pain
, VAS 7 to 8 – severe pain , VAS 9 to 10 -
excruciating pain. After surgery patient shifted to PACU and observed for
hemodynamic parameters, duration of sensory block, duration of motor block,
degree of postoperative analgesia and need of rescue analgesic. Hypotension,
defined as a decrease of systolic blood pressure by more than 30% from baseline
or a fall below 90 mmHg, was treated with IV boluses of ephedrine 5 mg and IV
fluid as required. Bradycardia, defined as heart rate < 60 bpm, was treated
with IV atropine 0.6 mg. The incidence of adverse effects, such as nausea,
vomiting, shivering, pruritus, respiratory depression, sedation, and
hypotension was recorded. |