| CTRI Number |
CTRI/2024/04/065069 [Registered on: 02/04/2024] Trial Registered Prospectively |
| Last Modified On: |
01/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A future study involving observation aimed to assess pain occurring after surgery at the surgical sites in head and neck cancer patients who were undergoing cosmetic surgery. |
|
Scientific Title of Study
|
Postoperative donor site pain in head and neck cancer patients following reconstructive free
tissue transfer surgery: A Prospective Observational Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Project no 4330 Version 1.0 dated 12 Sept 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vandana Agarwal |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital,Mumbai |
| Address |
Department of Anesthesia, Critical Care and Pain, 2nd Floor, Main Building, Tata Memorial Hospital, Parel Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
9819762668 |
| Fax |
|
| Email |
vandanachaukar@hotmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vandana Agarwal |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital,Mumbai |
| Address |
Department of Anesthesia, Critical Care and Pain, 2nd Floor, Main Building, Tata Memorial Hospital, Parel Mumbai
MAHARASHTRA 400012 India |
| Phone |
9819762668 |
| Fax |
|
| Email |
vandanachaukar@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Komal Nikhare |
| Designation |
Junior Resisdent |
| Affiliation |
Tata Memorial Hospital,Mumbai |
| Address |
Department of Anesthesia, Critical Care and Pain, 2nd Floor, Main Building, Tata Memorial Hospital, Parel Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
8530609664 |
| Fax |
|
| Email |
komalnikhare1994@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital, Parel Mumbai-12 |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Dr E Borges Road, Parel Mumbai-12 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Any |
Not Any |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Komal Nikhare |
Tata Memorial Hospital, Mumbai |
Room No MB101 Male General Ward and MB102, Female General Ward, First Floor, Main Building, Tata Memorial Hospital, Dr E Borges Road, Parel, Mumbai MAHARASHTRA |
8530609664
komalnikhare1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- Tata Memorial Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C068||Malignant neoplasm of overlappingsites of other and unspecified parts of mouth, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not Any |
Not Any |
| Comparator Agent |
Not Any |
Not Any |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All adults age more than 18 years patients undergoing head and neck surgery with free flap reconstruction. |
|
| ExclusionCriteria |
| Details |
3 Age less than 18 years
2 Patients requiring prolonged post-operative ventilator support more than 2 days
1 Pregnant and Lactating women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence and severity of donor site pain in the postoperative period |
up to day 5 after enrollment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1 Nature of pain Somatic or neuropathic based on patients description |
up to day 5 after enrollment |
| 2 Incidence of Neuropathic pain |
up to day 5 after enrollment |
| 3 Duration of analgesics used in the postoperative period |
up to day 5 after enrollment |
| 4 Need for Acute Pain Services referral |
up to day 5 after enrollment |
|
|
Target Sample Size
|
Total Sample Size="250" Sample Size from India="250"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Introduction:
Microvascular surgery has become a
gold standard for reconstruction in head and neck cancers. Radial artery,
Antero lateral thigh and Fibula osteo-cutaneous flap are three most popular
free flaps for reconstruction following head and neck cancer resections. The
goals of reconstructive surgery are to restore appearance and functions like
speech, swallowing. The success rate of free flapis more than 95%in majority of
centers.
However, there are certain
disadvantages such as mild postoperative deficits and rarelypatients may
experience significant donor-site morbidity. Minimizing flap donor site
morbidity is equally important.Donor site complications are hematoma,
infection, wound dehiscence, sensory loss, pain, gait disturbances, limb
weakness, neuroma, seroma, etc. The overall incidence of acute pain in head and
neck cancer surgery is high. Pathological cancer staging, surgicalcomplexity,
tumor site are associated with increase in severity of pain. In addition
treatment, these patients may often be on mild to moderate analgesics for acute
pain.Hinther et al,reported high prevalence of chronic postoperative opioid use
in patients undergoing head and neck cancer surgery with free flap
reconstruction. They identified preoperative opioid use, prior tobacco use, tumor
stage, and adjuvant treatment as risk factors for chronic postoperative opioid
use.The etiology of postoperative chronic opioid use are complex and
multifactorial.Postoperative period isvery crucial forachieving optimal
analgesia with minimal side effects but also decreasing the risk of chronic
opioid use.
To the best of our knowledge, there is
no literature evaluating impact ofreconstructive surgery and donor site pain on
overall incidence of pain in head and neck surgery
Donor site pain can be due to
multitude factors such as nerve injury, muscle excision and injury, bone
excision causing neuropathic, somatic pain. It may be anadditional source pain,
morbidity and quality of life of these patients. However, there is sparse
literature evaluating the severity, duration of acute donor site pain
associatedmorbidity,use and duration of postoperative opioids and its impact on
quality of life.
Methods and materials:
After IEC and CTRI approval, patients
will be screened one day before surgery for enrollment in the study. Informed
consent form will be administered in the ward following hospital admission. All
patients undergoing head and neck cancer surgery in TMH will be recruited.
Perioperative data of patients undergoing elective head and neck cancer surgery
will be recorded in the case record form. Patients will be followed until
postoperative day (POD)5. Pain score (NRS) at donor site (i.e. flap and skin
graft), and surgical site will be recorded once a day. The lowest, and worst
pain score both at rest and on movement will be recorded. NRS will be recorded
on postoperative day 1, 3, and 5. Brief
Pain Inventory (BPI) and Pain DETECT questionnaire will be administered at discharge.
Statistical analysis:
Descriptive data will be expressed as
mean or median depending on the distribution of data and to report the results
of the questionnaire items. Categorical data will be analyzed using the
chi-square test or Fisher Exact test (for binary data). Logistic
regression will be used for multivariate analysis to find
predictive factors associated with NRS score >5.P-value < 0.05 will be
considered statistically significant.We will analyse the data at the end of May
2024, for the purpose of thesis.
Ethical considerations:
Patients
will be identified by a unique no. and access to study documents will be
available only to the investigators and the Institutional Ethics Committee. The
trial will be conducted in compliance with the “Ethical Guidelines for
Biomedical Research on Human Participants†by the ICMRand ICH-GCP and according
to approved study protocol and applicable regulations. |