| CTRI Number |
CTRI/2021/11/038143 [Registered on: 18/11/2021] Trial Registered Prospectively |
| Last Modified On: |
16/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Pain relief with USG guided TAP block after lower segment cesarean section. |
|
Scientific Title of Study
|
Effectiveness of post operative analgesia of ultrasound guided transversus abdominis plane block after lower segment cesarean section - A randomized control trail |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrNirali N Panchal |
| Designation |
Associate Professor, Department of anesthesia |
| Affiliation |
Pramukhswami medical college, Karamsad |
| Address |
Department of anesthesia, Pramukhswami medical college, Karamsad
Anand GUJARAT 388325 India |
| Phone |
9825031808 |
| Fax |
|
| Email |
dr.niralipanchal@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DRNIRALI PANCHAL |
| Designation |
Associate professor, department of anesthesiology |
| Affiliation |
H.M.PATEL center of medical care and education |
| Address |
Department of aneasthesiology,H.M.PATEL center medical care and education,shree krishna hospital,gokalnagar,karamsad
Anand sojitra road, ANAND
ANAND
GUJARAT
Anand GUJARAT 388325 India |
| Phone |
9825031808 |
| Fax |
|
| Email |
dr.niralipanchal@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Prachi Shah |
| Designation |
Resident doctor |
| Affiliation |
Pramukhswami medical college, Karamsad |
| Address |
Department of anesthesiology, H.M.PATEL center of medical care and education, Shree krishna hospital, gokalnagr
karamsad
Anand-sojitra road,anand
ANAND
GUJARAT
Anand GUJARAT 388325 India |
| Phone |
8469280054 |
| Fax |
|
| Email |
shahprachi543@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pramukh swami medical college,shree krishna hospital, gokalnagar, karamsad Anand-sojitra
ANAND-388325 |
|
|
Primary Sponsor
|
| Name |
Shree krishna hospital |
| Address |
Anand-sojitra road,karamsad
Gujarat |
| Type of Sponsor |
Private medical college |
|
|
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 |
| DRNIRALI PANCHAL |
Pramukh swami medical college, shree krishna hospital |
Department of aneasthesiology,
Anand
Anand
Gujarat Anand GUJARAT |
9825031808
dr.niralipanchal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| H.M.PATEL CENTRE OF MEDICAL CARE AND EDUCATION |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intravenous Diclofenac sodium as post operative analgesia and put ultrasound probe at transversus abdominis plane (TAP) block site |
Intravenous Diclofenac sodium will be given after completion of lower segment cesarean section and to avoid bias we will put ultrasound probe at transversus abdominis plane (TAP) block site bilaterally. |
| Intervention |
Ultrasound guided transversus abdominis plane block |
Ultrasound guided transversus abdominis plane (TAP) block with 0.5% Bupivacaine with 4mg Dexamethasone on each side after completion of lower segment cesarean section as a post operative analgesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1)Patients with ASA II-III physical status
2)Age 18-40 years
3)Patients undergoing lower segment cesarean section under spinal anesthesia. |
|
| ExclusionCriteria |
| Details |
1)Patients refusal to regional anesthesia
2)Patients having allergy to local anesthetic drug
3)Patients having allergy to diclofenac
4)Patients with PIH
5)Patients with gestational diabetes
6)Presence of bleeding disorder or coagulopathy
7)If there is infection in the area where block is to be performed. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Assess degree and duration od analgesia by ultrasound guided transversus abdominis plane block |
0,2ND,4TH,6TH,8TH,12TH,24TH HOURS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Assess the requirement of rescue analgesia after transversus abdominis plane block with in 24 hours. |
WITH IN 24 HOPURS |
|
|
Target Sample Size
|
Total Sample Size="54" Sample Size from India="54"
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)
|
20/11/2021 |
| 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="1" Months="6" 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
|
Pain is an unpleasant emotional and sensory experience, substantial pain and discomfort are anticipated after cesarean delivery by most of the patients. After a cesarean section, good post-operative analgesia is important for the mother to optimally care for her neonate, effective breastfeeding, and also reduce the risk of thromboembolic disease, respiratory complications and reduce hospital stay due to early mobility of the patient. At present multimodal analgesia is used with iv/im- opioids, NSAIDs, PCA, and neuraxial blocks with opioids. However unwanted side effects like sedation, nausea, vomiting, pruritus, occasionally respiratory depression remain a major drawback for opioids. Ultrasound-guided TRANSVERSUS ABDOMINIS PLANE BLOCK - a regional anesthesia technique, one of the most effective methods for providing analgesia after lower abdominal surgeries. TRANSVERSUS ABDOMINIS PLANE BLOCK – block the neural afferents of the anterior abdominal wall after spreading the local anesthetic agent in the neuro fascial plane between the internal oblique and transversus abdominis muscle containing thoracolumbar nerves from T10 to L1. The ultrasound-guided block technique is relatively safe and associated with minimal complications. The purpose of the study is to compare the postoperative analgesic effectiveness of ULTRASOUND GUIDED TRANSVERSUS ABDOMINIS PLANE BLOCK after lower segment cesarean section overuse of another mode of intravenous analgesic drugs. 68 patients of ASA (American Society of anesthesia) II to ASA III physical status who are undergoing nonurgent lower segment cesarean section via Pfannenstiel incision will be recruited to participate in the study. We are considering a moderate effect size of 0.7. We require 27 patients in each group to achieve 80% power allowing for 5% type I error. Total 54 participants, 27 in each group will be divided randomly into GROUP T and GROUP C using winpepi software. A randomized envelope will be opened just before the cesarean section and the participants will be assigned either group T or group C. All participants either in group T or in group C will be receiving spinal anesthesia under all aseptic precautions with INJ BUPIVACAINE 0.5% (heavy) 1.8 -2.0 ml, after completion of the surgery, skin closure, and dressing participants in group T will receive ultrasound-guided bilateral TAP block with hyperbaric INJ BUPIVACAINE 0.25%,40 ml with the addition of INJ DEXAMETHASONE 8mg (adjuvant). 4mg of INJ DEXAMETHASONE with 20ml of INJ BUPIVACAINE 0.25% will be given on both sides respectively and this combination would prolong the analgesic effect of TAP block for approximately 12 to 24 hours. Participants in group C will be receiving i/v diclofenac 75 mg at the end of surgery. Ultrasound-guided TAP block will be performed by a senior resident and/or consultant who is experienced for ultrasound-guided regional anesthesia, while performing the block patient is positioned supine and with a linear array transducer placed in a transverse plane to the lateral abdominal wall at the midaxillary line, between the lower costal correct neurovascular plane. The image produced shows (from above downwards) skin, subcutaneous tissue, fat, external oblique, internal oblique, transversus abdominis. The peritoneum and bowel loops may also be visualized deeper into the muscles. A long 7-10 cm needle is inserted in the plane of the transducer directly under the probe and advanced until it reaches the plane between the internal oblique and transversus abdominis muscles. The needle also introduced a few centimeters medial to the probe (a distance equivalent to the depth of the plane as viewed on ultrasound image). The probe will have to follow the needle entry point medially in its superficial path and then return to its original position as the needle is directed deeper. Upon reaching the plane 2ml of normal saline is injected to confirm the correct needle placement, following careful negative aspiration (non-appearance of the blood) 20 ml of the local anesthetic solution is injected observing for an elliptical separation between the two fascial layers. The transversus abdominis plane is visualized expanding with the injection (as a hypoechoic space). The assessment of the intensity of the pain post-operatively after transfer of patients from Operation Theatre to PACU (POST OPERATIVE ANESTHESIA CARE UNIT). Each patient will be assessed at 0, 2, 4, 6, 8, 12, and 24 hours by an independent observer who will be unaware of the group allocation for the degree of pain using the VAS score (0-10 scale). Also, the time for first rescue analgesia will be noted and compared in both the groups, rescue analgesia in the form of inj tramadol 1mg/kg iv will be given if the vas score will be more than 4. A total number of rescue analgesia during a period of 24 hours will also be noted. |