| CTRI Number |
CTRI/2024/09/073871 [Registered on: 13/09/2024] Trial Registered Prospectively |
| Last Modified On: |
11/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of the drug dexmedetomidine in improving the treatment of pain after surgery, in patients undergoing caesarean section |
|
Scientific Title of Study
|
Efficacy and safety of Dexmedetomidine as an adjuvant in local wound infiltration for postoperative pain relief in caesarean section: a prospective, randomized, double blinded 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 |
Dr Suman Chattopadhyay |
| Designation |
Professor & Head of the Department |
| Affiliation |
Midnapore Medical College |
| Address |
Department of Anaesthesiology, Midnapore Medical College, Vidyasagar Road, Midnapore, Paschim Medinipur
Medinipur WEST BENGAL 721101 India |
| Phone |
9830234881 |
| Fax |
|
| Email |
sumanc24@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Arun Kumar Mandi |
| Designation |
Assistant Professor |
| Affiliation |
Midnapore Medical College |
| Address |
Department of Anaesthesiology, Midnapore Medical College, Vidyasagar Road, Midnapore, Paschim Medinipur
Medinipur WEST BENGAL 721101 India |
| Phone |
8697633923 |
| Fax |
|
| Email |
mandiarunkr87@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Nipon Haque |
| Designation |
Post graduate trainee |
| Affiliation |
Midnapore Medical College |
| Address |
Department of Anaesthesiology, Midnapore Medical College, Vidyasagar Road, Midnapore, Paschim Medinipur
Medinipur WEST BENGAL 721101 India |
| Phone |
9830956555 |
| Fax |
|
| Email |
wishnipon@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college post graduate thesis fund,
Office of the Principal,
Midnapore Medical College, Vidyasagar Road,
Midnapore,
Paschim Medinipur,
PIN - 721101 |
|
|
Primary Sponsor
|
| Name |
Principal, Midnapore Medical College |
| Address |
Office of the Principal, Midnapore Medical College, Vidyasagar Road, Midnapore, Paschim Medinipur, PIN - 721101, West Bengal |
| 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 Nipon Haque |
Midnapore Medical College & Hospital |
Dept. of Anaesthesiology, 4th floor, Integrated Clinical Building,
Vidyasagar Road, Midnapore, Paschim Medinipur, PIN - 721101 Medinipur WEST BENGAL |
9830956555
wishnipon@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Midnapore Medical College |
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 |
| Intervention |
Inj. Dexmedetomidine 1 ml (100 mcg) |
Inj. Dexmedetomidine 1 ml (100 mcg) administered as adjuvant during local wound infiltration before skin closure. This is to be given only ONCE (i.e. during local wound wound infiltration before skin closure) as a STAT dose. |
| Comparator Agent |
Inj. normal saline (0.9%) 1 ml |
Inj. normal saline (0.9%) 1 ml administered as adjuvant during local wound infiltration before skin closure. This is to be given only ONCE (i.e. during local wound wound infiltration before skin closure) as a STAT dose. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients with singleton pregnancy with no obstetric complications (pre-eclampsia, antepartum haemorrhage)
2. Patients undergoing elective caesarean section
3. Patients having ASA grade II
4. Patients with normal BMI (18.5 - 24.9)
5. Patients giving valid consent
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal.
2. Patients with multiple pregancy.
3. Patients with obstetric complications (antepartum haemorrhage, pre-eclampsia).
4. Patients with history of drug abuse.
5. Patients with history of allergy to the study drug dexmedetomidine.
6. Patients with history of diabetes mellitus, heart, liver, kidney, coagulation or mental disorders.
7. Patients with communication disabilities.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The time at which the first analgesic is requested (rescue analgesia) in the postoperative period |
At 2, 4, 6, 8, 10 and 12 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total dose of analgesic consumption in 12 hours in postoperative period |
At 12 hours |
| Visual analog scale |
At 2, 4, 6, 8, 10 and 12 hours |
| Heart rate |
At 30, 60, 90, 120 minutes |
| Mean arterial pressure |
At 30, 60, 90, 120 minutes |
| Nausea, vomitting |
At 2, 4, 6, 8. 10 and 12 hours |
| Time of starting movement in postoperative period |
At 2, 4, 6, 8, 10 and 12 hours |
| Time of starting to eat in postoperative period |
At 2, 4, 6, 8, 10 and 12 hours |
| Time of initiation of breast-feeding |
At 2, 4, 6, 8, 10 and 12 hours |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
22/09/2024 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - ANY
- For how long will this data be available start date provided 01-12-2024 and end date provided 01-01-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Objective of research:
To compare the efficacy, regarding duration of postoperative analgesia, of local anaesthetic alone and local anaesthetic with dexmedetomidine, as adjuvant, in local wound infiltration in patients undergoing caesarean section.
Background of research:
Postoperative pain and opioid-related adverse drug events are still among the principal factors affecting the rapid recovery and discharge of patients undergoing surgery. It is an important concern for women undergoing caesarean section, a routine surgery in our institute. Breakthrough pain is a problem in the postoperative period leading to increased opioid consumption.
Addressing postoperative pain in caesarean section is crucial as mothers are expected to recover rapidly and care for the newborn within a few hours following surgery. Effective postperatve analgesia can enhance recovery and decrease morbidity.
Duration of analgesic can be prolonged by systemic or local route. Local wound infiltration before is a tried and tested method of improving postoperative analgesia. It is an easy, effective and affordable technique which can enhance postoperative analgesia in different types of surgeries without major complications. This technique has been shown to play an active role in relieving postoperative pain and reducing opioid consumption. Advantages are safety, simplicty and enhanced postoperative analgesia, especially during mobilisation. In recent years, procedure-specific postoperative pain (PROSPECT) Working Group has recommended wound infiltration for open abdominal surgeries.
Dexmedetomidine is a highly selective agonist of alpha-2 adrenergic receptor with sedative, analgesic but not anaesthetic characteristic, making it a safe adjuvant in various clinical settings. In various studies, dexmedetomidine as an adjucant to local anaesthetics has proven effectiveness for postoperative pain relief in various procedures including abdominal hysterectomy, knee arthroplasty. Methodology:
This is a single centre, hospital based, double blinded, randomised controlled study on patients posted for elective caesaeran section under spinal anaesthesia, in the obstetrics operation theatre, the post-anaesthesia care unit and the post-operative ward at Midnapore Medical College & Hospital, Paschim Medinipur, over a period of 12 months. A total of 40 patients will be randomly divided into two groups where one group will receive local wound infiltration with dexmedetomidine as adjuvant and the other grouo will receive local wound infiltration with normal saline as adjuvant. The required parameters will be monitored in the monitored for upto 12 hours in the postoperative period.
Expected outcome of proposed study:
In this study we expect to find out if in reality dexmedetomidine as an adjuvant to local anaesthetic in local wound infiltrarion can provide superior pain management in terms of duration of postoperative analgesia, total dose of analgesic consumpton in 12 hours post-op, visual analog scale, the time of starting of movement, eating, breast-feeding, adverse effects of medications. |