| CTRI Number |
CTRI/2025/03/083443 [Registered on: 26/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparing two different techniques of rectus sheath blocks in enhancing the analgesic efficacy in cancer patients undergoing abdominal surgeries |
|
Scientific Title of Study
|
Comparison of spread of local anaesthetic mixture and their analgesic efficacy between two point and four point rectus sheath block in cancer patients undergoing midline laparotomy surgeries |
| 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.Sivabalakumaran |
| Designation |
FNB oncoanaesthesia |
| Affiliation |
MVR Cancer Center and Research Institute |
| Address |
plot no.21,22, Shiva illam, 1st main road, library street, Ganapathi Nagar, Murungapakkam, Pondicherry
Pondicherry
PONDICHERRY
605004
India |
| Phone |
9600994850 |
| Fax |
|
| Email |
k.sivabalakumaran@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Sivabalakumaran |
| Designation |
FNB oncoanaesthesia |
| Affiliation |
MVR Cancer Center and Research Institute |
| Address |
Plot no.21,22, Shiva Illam, 1st main road, library street, Ganapathi Nagar, Murungapakkam, Pondicherry
Pondicherry
PONDICHERRY
605004
India |
| Phone |
9600994850 |
| Fax |
|
| Email |
k.sivabalakumaran@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Sivabalakumaran |
| Designation |
FNB oncoanaesthesia |
| Affiliation |
MVR Cancer Center and Research Institute |
| Address |
Plot no.21,22, Shiva Illam, 1st main road, Library street, Ganapathi Nagar, Murungapakkam, Pondicherry
Pondicherry
PONDICHERRY
605004
India |
| Phone |
9600994850 |
| Fax |
|
| Email |
k.sivabalakumaran@gmail.com |
|
|
Source of Monetary or Material Support
|
| MVR Cancer Centre and Research Institute, CP 13/516, via B,c,NIT, Vellalassery, Poolacode,Kerala 673601 |
|
|
Primary Sponsor
|
| Name |
not applicable |
| Address |
nil |
| Type of Sponsor |
Research institution |
|
|
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 sivabala kumaran |
MVR Cancer Centre and Research Institute |
Department of Anaesthesiology, MVR Cancer Centre, 2nd floor, OT block, CP 13/516, via, B, C, NIT, Vellalassery, Poolacode, Kerala 673601
Kozhikode
KERALA |
09600994850
k.sivabalakumaran@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MVR cancer centre and research institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C15-C26||Malignant neoplasms of digestive organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
2 point rectus sheath block |
0.25% ropivacaine- 30ml each site given at 2 sites(total 150mg) as a single shot injection in the muscular plane under ultrasound guidance |
| Comparator Agent |
4 point rectus sheath block |
0.25% ropivacaine- 15ml each site given at 4 sites (total 150mg) as a single shot injection in the muscular plane under ultrasound guidance |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patient willing to give informed consent, assessed under ASA 1-4, weight more than 50kg |
|
| ExclusionCriteria |
| Details |
patient with low IQ, allergic to LA, infection at the site of injection |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate and compare the spread of LA in rectus sheath plane between two techniques |
10minutes after the block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate & compare the efficacy of analgesia intraoperatively based on vitals & requirement of epidural & intravenous analgesics & postoperatively based on VAS score between two techniques
|
intraoperatively every 10min until first 1hr & 30min thereafter & during postop period at 0, 2, 4, 6, 8 & 12hrs |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
08/04/2025 |
| 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="0"
Months="2"
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
|
BACKGROUND: Rectus sheath block (RSB) provides excellent
analgesia for midline abdominal procedures. The
lacuna in the literature in comparing 2points with 4points RSB in conjunction
with the spread of drugs and its analgesic efficacy during intraoperative and
postoperative period is being addressed in this study. AIM: To compare the
efficacy of analgesia and drug spread between the two techniques of RSB in
midline laparotomy surgeries. METHODOLOGY: patients were divided into
group-1(n=33) receiving 2-point RSB and group-2(n=33) receiving 4-point RSB
using 0.25% ropivacaine with 4mg dexamethasone. People willing to give written
informed consent, weighing >50kg and aged >18years assessed under ASA 1
to 4 are included in this study. Outcomes such as spread of local anaesthetics between 2 techniques after 10min of block procedure and their analgesic efficacy intraoperatively based on vitals recorded every 10min for first 1hour and thereafter every 30min once till the end of surgery, requirement of rescue
analgesics (epidural bolus and opioids) and postoperatively based on VAS score recorded at 0,1,2, 4,6,8,12 hrs and rescue analgesics used were noted. RATIONAL FOR THE STUDY: Even though there are many literatures stating the
efficacy of analgesia with rectus sheath block none of them explained the
spread of local anaesthetics in posterior rectus sheath plane. There is a
lacuna in the literature in comparing the spread of local anaesthetics between
2points and 4points RSB and its efficacy with respect to intraop and post op
analgesia. |