| CTRI Number |
CTRI/2023/10/058226 [Registered on: 04/10/2023] Trial Registered Prospectively |
| Last Modified On: |
29/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the effectiveness of equal doses of Tramadol in wound infiltration versus transversus abdominis plane block after cesarian section under spinal anaesthesia in terms of post operative pain relief and early walking |
|
Scientific Title of Study
|
Comparing efficacy of equal doses of Tramadol in wound infiltration versus transversus abdominis plane block after LSCS under spinal anaesthesia in terms of post operative analgesia and early ambulation - A prospective double blind randomized 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 Uttara Saha |
| Designation |
Post graduate student |
| Affiliation |
IMS and SUM Hospital |
| Address |
Department of Anaesthesiology, IMS and SUM Hospital, k8 kalinganagar, PO - Ghatakia, Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
7005062562 |
| Fax |
|
| Email |
uttarasaha88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Diptimayee Mallik |
| Designation |
Associate Professor |
| Affiliation |
IMS and SUM Hospital |
| Address |
Department of Anaesthesiology, IMS and SUM Hospital, k8 kalinganagar, PO - Ghatakia, Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
9861159151 |
| Fax |
|
| Email |
dr.diptimayee2010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Uttara Saha |
| Designation |
Post graduate student |
| Affiliation |
IMS and SUM Hospital |
| Address |
Department of Anaesthesiology, IMS and SUM Hospital, k8 kalinganagar, PO - Ghatakia, Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
7005062562 |
| Fax |
|
| Email |
uttarasaha88@gmail.com |
|
|
Source of Monetary or Material Support
|
| IMS AND SUM HOSPITAL, K8 KALINGANAGAR, PO GHATAKIA, KHORDA, BHUBANESWAR 751003,ODISHA |
|
|
Primary Sponsor
|
| Name |
Dr. Uttara Saha |
| Address |
IMS and SUM Hospital, k8 kalinganagar, PO - Ghatakia, Bhubaneswar - 751003, Odisha, India |
| 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 Uttara Saha |
INSTITUTE OF MEDICALSCIENCES & SUM HOSPITAL |
Department of anaesthesiology, 1st floor, k8 kalinganagar, P.O. Ghatakia, Bhubaneswar- 751003
Khordha
ORISSA |
7005062562
uttarasaha88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, INSTITUTION OF MEDICAL SCIENCES (IMS) AND SUM HOSPITAL |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O85-O92||Complications predominantly related to the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tramadol |
The patients posted for lower segment caesarean section will be evaluated for any allergic reaction to Tramadol by performing skin test by injecting 0.1ml of Tramadol. The total dose of Tramadol 2mg/kg will be diluted with 20ml NS,patients will be randomized into two groups and will receive either wound infiltration (Group W) or Transversus Abdominis Plane block (Group T). |
| Intervention |
Transversus Abdominis Plane Block and Wound Infiltration |
Pregnant female patients posted for lower segment caesarean section requiring spinal anaesthesia will be randomized into 2 groups,one group will receive wound infiltration, given just before the skin closure
, with Tramadol (2mg/kg bodyweight, diluted in 20ml NS) and the second group will receive Transversus Abdominis Plane Block where the diluted drug (Tramadol 2mg/kg body weight is diluted with 20ml NS) is divided in to two halves and administered post operatively, under USG guidance, between lower costal margin and iliac crest on both sides, for post-operative analgesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients posted for Lower segment caesarean section without any other comorbidities
2. Patient within the age group of 18 to 45 years
3. Patients under American society of Anesthesiologists (ASA) Physical status II
4. Patients with BMI <35 kg/m2
|
|
| ExclusionCriteria |
| Details |
1. Patient’s refusal
2. Patients under ASA III, ASA IV
3. Patient known allergic to local anesthetic agents and Tramadol
4. Patients with any coagulation disorders
5. Patients with severe cardiopulmonary, renal or liver disease, pre-eclampsia, eclampsia and morbidly obese.
6. Spine deformities or skin infection at local sites
7. Patients complaining of nausea and vomiting intraoperatively
8. Patient known for opioid dependency or other drug abuse
9. Duration of surgery more than 90mins.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the duration of analgesia after wound infiltration versus TAP block with Tramadol , in LSCS patients. |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
(a) to know the total analgesic consumption in 24hours.
(b) to know the incidence of side effects like post operative nausea, vomiting and rashes at the site of injection of tramadol
|
24 hours |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
10/10/2023 |
| 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="6"
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
|
This study aims to compare the efficacy of equal doses of Tramadol in wound infiltration versus Transversus Abdominis Plane block after LSCS under Spinal anaesthesia for post-operative analgesia.
The primary objective is to assess the duration of analgesia after wound infiltration versus Transversus Abdominis Plane block with Tramadol , in Lower Segment caesarean section patients. The Secondary objective is (a) to know the total analgesic consumption in 24hours. (b) to know the incidence of side effects like post operative nausea, vomiting and rashes at the site of injection of Tramadol.
Methodology - This prospective study will be conducted at our institution over a period of 1.5 years. In this study 140 American society of Anesthesiologists (ASA) physical status II female patients between age 18 to 45 years with BMI <35kg/m2 posted for lower segment caesarean section requiring spinal anesthesia will be included. After taking written informed consent, patients will be randomized to two groups (n= 140) by block randomization. All patients will be thoroughly examined pre-operatively which include history, general physical examination, and checking the vital parameters of the patients such as blood pressure, pulse, respiratory rate and systemic examination, and ASA grading. The patients will be evaluated for any allergic reaction to Tramadol by performing skin test by injecting 0.1ml of Tramadol. The patients with a contraindication to spinal anesthesia or major neurological, cardiovascular, metabolic, respiratory, renal disease, or coagulation abnormalities or allergic to Tramadol will be excluded. While the patients are still on the operating table, patients will be randomized and will receive either wound infiltration (Group W) or TAP block (Group T).The total dose of Tramadol 2mg/kg will be diluted with 20ml NS. Wound infiltration will be given just before closure of the skin and in TAP block the diluted drug will be divided into 2 halves and will be given under USG guidance, between the lower costal margin and iliac crest on both sides, after closure of skin. Double blinding is done. The patient is blinded regarding the study drug and study procedure. The patient data collection and analysis will be done by anesthesiologists who are blinded regarding the study drug and study group. Immediately after the operation, the patients will be shifted to the post op recovery room. Considering the baseline VAS score as zero, the VAS score will be serially assessed at regular intervals starting from 60 min to till 24hrs post surgery. T0: Time of wound infiltration or TAP block T1: 1hr after TAP block or Wound infiltration T2: 2hrs after TAP block or Wound infiltration T3: 3hrs after TAP block or Wound infiltration T4: 4hrs after TAP block or Wound infiltration T5: 5hrs after TAP block or Wound infiltration T6: 6hrs after TAP block or Wound infiltration T7: 7hrs after TAP block or Wound infiltration T8: 8hrs after TAP block or Wound infiltration T12: 12hrs after TAP block or Wound infiltration T24: 24hrs after TAP block or Wound infiltration
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