| CTRI Number |
CTRI/2023/03/050432 [Registered on: 07/03/2023] Trial Registered Prospectively |
| Last Modified On: |
13/02/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to assess the ability of “PENS"- a medical device, in reducing pain levels after surgery in patients with cancer of cervix or endometrium |
|
Scientific Title of Study
|
EFFICACY OF PERCUTANEOUS ELECTRICAL NEUROSTIMUATION (PENS) OF THE AURICLE AS AN OPIOID SPARING POSTOPERATIVE ANALGESIC TECHNIQUE IN CANCER ENDOMETRIUM AND CANCER CERVIX PATIENTS
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sahithya Sriman |
| Designation |
Assistant Professor |
| Affiliation |
Cancer Institute (WIA) |
| Address |
Department of Anaesthesia and Pain and Palliative care
38 Sardar Patel road
Adyar, Chennai
Tamilnadu-600036
Chennai
TAMIL NADU
600036
India |
| Phone |
9840226923 |
| Fax |
|
| Email |
sahithyaadhithyan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sahithya Sriman |
| Designation |
Assistant Professor |
| Affiliation |
Cancer Institute (WIA) |
| Address |
Department of Anaesthesia and Pain and Palliative care
38 Sardar Patel road
Adyar, Chennai
Tamilnadu-600036
Chennai
TAMIL NADU
600036
India |
| Phone |
9840226923 |
| Fax |
|
| Email |
sahithyaadhithyan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sahithya Sriman |
| Designation |
Assistant Professor |
| Affiliation |
Cancer Institute (WIA) |
| Address |
Department of Anaesthesia and Pain and Palliative care
38 Sardar Patel road
Adyar, Chennai
Tamilnadu-600036
Chennai
TAMIL NADU
600036
India |
| Phone |
9840226923 |
| Fax |
|
| Email |
sahithyaadhithyan@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Sahithya Sriman |
| Address |
Department of Anesthesia and Pain and Palliative care,
Room No 10, Surgical block,
Cancer Institute (WIA)
38 Sardar Patel road
Adyar Chennai Tamilnadu 600036 |
| 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 Sahithya Sriman |
Cancer Institute (WIA) |
Department of Anesthesia and Pain and Palliative care,
Room NO 10, Surgical block,
38 Sardar Patel road
Adyar 600036
Chennai
TAMIL NADU |
9840226923
sahithyaadhithyan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CANCER INSTITUTE (WIA) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C539||Malignant neoplasm of cervix uteri, unspecified, (2) ICD-10 Condition: C541||Malignant neoplasm of endometrium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Once adequate NPO has been confirmed, under routine ASA guideline monitoring the patients are premedicated with fentanyl in a dosage of 1.5ug/kg followed by induction with propofol 1.5-2.5mg/kg and paralysed with vecuronium 0.1mg/kg. Following tracheal intubation anaesthesia will be maintained using an oxygen:nitrous oxide mixture combined with an inhalant. Analgesia with injection paracetamol at a dosage of 15mg/kg to be administered prior to incision placement. Supplementation with (short acting opioids) fentanyl at 0.5ug/kg for every hour from the time of induction based on hemodynamic parameters (i.e 20% increase from baseline heart rate and BP) with repeat doses if deemed necessary. Patients will have a SHAM device placed as per manufacturer’s protocol two hours priors to the estimated time of extubation and placement will be done by a clinician blinded to the study. The device will be physically similar to working device but without any stimulation properties. Assessment of pain scores will start in the immediate post-operative period after extubation. Postoperative analgesic regimen will be Injection paracetamol in a dosage of 15mg/kg every 6th hourly. Break through pain with NRS more than 4 will be managed with injection tramadol at 1mg/kg followed by 0.5mg/kg after 10mins in cases of persisting pain. Pain scores and analgesic requirements will be monitored up till pod 4. Device will be removed on POD 4. |
| Intervention |
Study group |
Once adequate NPO has been confirmed, under routine ASA guideline monitoring the patients are premedicated with fentanyl in a dosage of 1.5ug/kg followed by induction with propofol 1.5-2.5mg/kg and paralysed with vecuronium 0.1mg/kg. Following tracheal intubation anaesthesia will be maintained using an oxygen:nitrous oxide mixture combined with an inhalant. Analgesia with injection paracetamol at a dosage of 15mg/kg to be administered prior to incision placement. Supplementation with (short acting opioids) fentanyl at 0.5ug/kg for every hour from the time of induction based on hemodynamic parameters (i.e 20% increase from baseline heart rate and BP) with repeat doses if deemed necessary. Patients will have a working PENS device under trade name of Primary Relief placed as per manufacturer’s protocol two hours priors to the estimated time of extubation and placement will be done by a clinician blinded to the study. The mode of functioning would be continuous neurostimulation of 1-100 Hz frequency sweep. Assessment of pain scores will start in the immediate post-operative period after extubation. Postoperative analgesic regimen will be Injection paracetamol in a dosage of 15mg/kg every 6th hourly. Break through pain with NRS more than 4 will be managed with injection tramadol at 1mg/kg followed by 0.5mg/kg after 10mins in cases of persisting pain. Pain scores and analgesic requirements will be monitored up till pod 4. Device will be removed on POD 4 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
Diagnosed with CA-endometrium OR CA -cervix of stage I/II and post RT CA cervix patients coming for hysterectomy
Elective surgery
Informed consent obtained
ASA (American Society of Anaesthesiology) physical status 1-3
|
|
| ExclusionCriteria |
| Details |
Patient refusal
Cancer cervix other than the stages mentioned in inclusion criteria
ASA PS >3
Emergency surgery, Laparoscopic and robotic procedures
Unplanned postoperative ventilation
Allergy/sensitivity to adhesive
Active skin infection/lesion in the ear region
H/O of seizure or cerebral disease
H/O chronic pain and prolonged analgesic usage
H/O opioid dependence
H/O anxiety or psychiatric illness requiring treatment
Pre-existing implantable/ electronic on demand device
Patients who might require MRI in the study period
Patients with transmissible diseases
Patients with coagulopathies
Absolute or relative contraindication to drugs used in the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in postoperative pain scores as measured by NRS pain scale between 0-10 |
POD 0-4 Postoperative hours 0-hrs, 2-hrs, 4-hrs, 8-hrs,12-hrs, 18-hrs, 24-hrs, 36-hrs, 48-hrs, 72-hrs, 96-hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Postoperative:
Reduction in opioid consumption
Ease of patient ambulation/spirometry
Onset of bowel movements
Sedation scores
PENS device tolerability |
Post operative days 0-4
Sedation scale at postoperative hours 0-hrs, 2-hrs, 4-hrs, 8-hrs,12-hrs, 18-hrs, 24-hrs, 36-hrs, 48-hrs, 72-hrs, 96-hrs
NRS associated with mobility/ spirometry from POD 1-4 |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
01/04/2023 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to test the efficacy of PENS device (-a minimally invasive neurostimulation device which acts by stimulating the nerves around the auricle percutaneously) in decreasing pain scores in cancer endometrium / cervix patients after their elective laparotomy surgeries as the primary outcome. Adequate post operative pain relief through PENS device will help reduce the amount of opioid (the most commonly used analgesic agent) consumed in the post operative period and hence their associated side effects. The study will also analyse for improvements in other recovery parameters such as mobility, bowel movements, sedation scores, ease/ patient comfort with PENS device and these are translated as secondary outcomes |