| CTRI Number |
CTRI/2021/05/033570 [Registered on: 12/05/2021] Trial Registered Prospectively |
| Last Modified On: |
11/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trail effects of the drug magnesium sulfate over pain after surgery in patients undergoing surgery around anus when it is added to local anaesthetic solution in wound infiltration after the surgery |
|
Scientific Title of Study
|
Analgesic efficacy of addition of magnesium sulfate to bupivacaine wound infiltration technique in perianal surgeries: A prospective, randomized, clinical trail |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NAGALINGAM N |
| Designation |
Associate professor |
| Affiliation |
Sri Lakshmi Narayana Institute of Medical Science Medical College & Hospital |
| Address |
Dept Of Anaesthesiology, First Floor, Sri Lakshmi Narayana Institute of Medical Sciences,
Osudu Agaram Village, Villianur Commune, Kudapakkam Post
Pondicherry
PONDICHERRY
605502
India |
| Phone |
9655239900 |
| Fax |
|
| Email |
drnaga2k@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
NAGALINGAM N |
| Designation |
Associate professor |
| Affiliation |
Sri Lakshmi Narayana Institute of Medical Science Medical College & Hospital |
| Address |
Dept Of Anaesthesiology, First Floor, Sri Lakshmi Narayana Institute of Medical Sciences,
Osudu Agaram Village, Villianur Commune, Kudapakkam Post
Pondicherry
PONDICHERRY
605502
India |
| Phone |
9655239900 |
| Fax |
|
| Email |
drnaga2k@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NAGALINGAM N |
| Designation |
Associate professor |
| Affiliation |
Sri Lakshmi Narayana Institute of Medical Science Medical College & Hospital |
| Address |
Dept Of Anaesthesiology, First Floor, Sri Lakshmi Narayana Institute of Medical Sciences,
Osudu Agaram Village, Villianur Commune, Kudapakkam Post
Pondicherry
PONDICHERRY
605502
India |
| Phone |
9655239900 |
| Fax |
|
| Email |
drnaga2k@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Lakshmi Narayana Institute of Medical Science Medical College & Hospital, Osudu Agaram Village, Villianur Commune, Kudapakkam Post, Puducherry, 605502 |
|
|
Primary Sponsor
|
| Name |
NAGALINGAM N |
| Address |
Sri Lakshmi Narayana Institute of Medical Science Medical College & Hospital, Osudu Agaram Village, Villianur Commune, Kudapakkam Post, Puducherry, 605502 |
| 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 |
| NAGALINGAM N |
Sri Lakshmi Narayan Institute of Medical Sciences |
Dept Of Anaesthesiology, First Floor, Sri Lakshmi Narayana Institute of Medical Sciences,
Osudu Agaram Village, Villianur Commune, Kudapakkam Post
Pondicherry
PONDICHERRY |
9655239900
drnaga2k@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE(HUMAN STUDIES) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K603||Anal fistula, (2) ICD-10 Condition: K601||Chronic anal fissure, (3) ICD-10 Condition: K601||Chronic anal fissure, (4) ICD-10 Condition: K641||Second degree hemorrhoids, (5) ICD-10 Condition: K642||Third degree hemorrhoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Addition of magnesium sulfate drug to bupivacaine solution in wound infiltration technique in periananl surgeries |
wound infiltration with bupivacaine will be performed at the end of surgery for perianal surgeries. In the study group magnesium sulfate will be added to bupivacaine solution. in control group 1ml saline will be added to bupivacaine solution |
| Comparator Agent |
magnesium sulfate |
100 microgram will be added to bupivacaine solution |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
ASA I & II patients of Age 18-50 years of both gender with normal range of BMI undergoing Perianal surgeries like fissure in ano, fistula in ano and haemorrhoidectomy. |
|
| ExclusionCriteria |
| Details |
ASA III and above, Obese, underweight subjects(BMI) , pregnant women, patients with bleeding and clotting disorders, allergic to local anesthetic agents,inadequate spinal blockade supplemented by other drugs and complicated surgeries will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Addition of magnesium sulfate to local anaesthetic solution prolongs the postoperative analgesia. |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Addition of magnesium sulfate to local anaesthetic solution reduces defecation pain and helps in early mobilisation |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/05/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
Comparison of analgesic efficacy of bupivacaine, bupivacaine and magnesium sulfate in would infiltration technique in perianal surgeries: A prospective, randomized controlled study |
|
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
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drnaga2k@gmail.com].
- For how long will this data be available start date provided 03-05-2022 and end date provided 03-05-2025?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
50 patients undergoing perianal surgeries are selected and will be dividied into 2 groups
of 25 each. Informed consent will be obtained. Surgery will bedone under spinal anaesthesia using 2 ml 0.5%
hyperbaric Bupivacaine. At the end of surgery, wound infiltration will be done in
all patients.
Group A will receive
15ml 0.5% bupivacaine and 1 ml saline
Group B will receive
15ml 0.5% bupivacaine and 100 µg of mgso4
Surgeries ended up in complications will be removed from
the study. Data will be collected and processed for analysis
Study
variables and their measurement: General parameters i.e. Age,
Gender, BMI, Duration of surgery and duration of
spinal blockade, vitals will be observed every 30 min till first 2 hrs, at 6,
12, 18 and 24 hr. Pain score at rest and on movement using Visual Analogue
scale (VAS) 0-10 assessed every 2 hrs from the end of surgery till 24 hrs, incidence of postoperative nausea and vomiting, time of mobilisation, pain score at the time of defacation, parenteral analgesic requirements in 24 hrs period. Inj. Tramadol 50 mg IV was used as rescue analgesic when VAS score reaches 4 and duration of postoperative analgesia is measured as time when
VAS first reaches 4. |