CTRI Number |
CTRI/2023/09/057698 [Registered on: 15/09/2023] Trial Registered Prospectively |
Last Modified On: |
13/09/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
To compare epidural analgesia and recuts sheath analgesia for pain management in abdominal surgery. |
Scientific Title of Study
|
A comparison of epidural analgesia with recuts sheath analgesia for post operative pain management in abdominal surgery under general anaesthesia |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Mukesh Kumar |
Designation |
Assistant Professor |
Affiliation |
GGS Medical College and Hospital |
Address |
Deptt of anaesthesia
GGSMCH Faridkot GGSMCH Faridkot Faridkot PUNJAB 151203 India |
Phone |
9464887097 |
Fax |
|
Email |
mukeshktala@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Mukesh Kumar |
Designation |
Assistant Professor |
Affiliation |
GGS Medical College and Hospital |
Address |
Deptt of anaesthesia
GGSMCH Faridkot GGSMCH Faridkot Faridkot PUNJAB 151203 India |
Phone |
9464887097 |
Fax |
|
Email |
mukeshktala@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Sumit Kumar |
Designation |
Junior Resident |
Affiliation |
GGSMCH |
Address |
Deptt of anaesthesia
GGSMCH Faridkot GGSMCH Faridkot Faridkot PUNJAB 151203 India |
Phone |
9518437940 |
Fax |
|
Email |
drsumitkaushik18414@gmail.com |
|
Source of Monetary or Material Support
|
Department of anaesthesiology GGSMCH Faridkot |
|
Primary Sponsor
|
Name |
Dr Mukesh Kumar |
Address |
Deptt of anaesthesiology GGSMCH Faridkot |
Type of Sponsor |
Government medical college |
|
Details of Secondary Sponsor
|
Name |
Address |
Dr Ashwini Kumar |
Deptt of Gen. surgery
GGSMCH Faridkot |
Dr Sarvjeet Kaur |
Deptt of anaesthesia GGSMCH Faridkot |
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Sumit Kumar |
,Guru Gobind Singh medical college and Hospital |
Deptt of anaesthesiology,Guru Gobind Singh medical college and Hospital Faridkot PUNJAB |
9518437940
drsumitkaushik18414@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Ethics committee of GGSMCH Faridkot |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K929||Disease of digestive system, unspecified, (2) ICD-10 Condition: K639||Disease of intestine, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
epidural analgesia |
Ropivacaine (0.25%)will be given through epidural catheter for post operative pain management in abdominal surgeries. |
Intervention |
Recuts sheath analgesia |
Ropivacaine (0.25%) will be given through catheters placed in bilateral recuts sheath or post operative pain management in abdominal surgeries. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
Patients with ASA 1 and 2
Patients undergoing abdominal surgeries under GA
|
|
ExclusionCriteria |
Details |
Patients with allergy to drug
Patients with coagulation disorders
Patient with spine deformities
Patients with abnormalities of spine
Any sign of local infection |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To study study postoperative analgesia in patients with epidural analgesia
To study postoperative analgesia in patients with recuts sheath analgesia
|
Till72 hours postoperative |
|
Secondary Outcome
|
Outcome |
TimePoints |
To compare postoperative analgesia in patients with epidural analgesia and and recuts sheath analgesia |
Till 72 hours postoperative |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
25/09/2023 |
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 Yet Recruiting |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
NA |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Neuroendocrine stress caused due to surgery, resulting in undesirable hemodynamic instability, alterations in metabolic response and malfunctioning of the immune system. Pain is a common cause of stress, therefore it should be adequately evaluated and treated both during surgery and afterwards. Pain is a very complex, subjective perceptual phenomenon. It’s dimensions like intensity, quality, duration and impacts varies from patient to patient. Abdominal incision surgeries are still necessary for a number of emergency and elective treatments, despite the rise of less invasive abdominal surgical techniques. Regional anaesthesia has become an integral and common component of both intraoperative anaesthesia and postoperative analgesia. For abdominal, major vascular, and cardiothoracic surgery, thoracic epidural anaesthesia is increasingly employed, followed by post-operative epidural analgesia.Pain management and severe sympatholysis can contribute to improved postoperative outcomes like increased respiratory function, decreased ileus, and protein sparing by allowing patients to cough, breathe deeply, drink, and move around. To successfully do an epidural block, one must have a thorough understanding of the differences between thoracic and lumbar anatomy.Local anaesthetics have different dermatomal sensory distribution depending on where they are injected. Despite having a noticeable caudal spread, high-thoracic epidurals have little cranial spread. In contrast, more cranial distribution happens after low-than-high or mid-thoracic epidurals. Higher concentrations of bupivacaine (0.5%) or its equivalent are preferred, as onset of sensory block is rapid and muscle relaxation is profound, thus reducing the need for intraoperative neuromuscular blocking agents and same can be repeated intraoperative and post operative periods. Abdominal trunk local anaesthetic (LA) blocks are one of the multimodal opioid-sparing strategies being used in the therapy of post-laparotomy pain.Effective post-laparotomy analgesia can be achieved while avoiding some of the negative effects associated with opioid and thoracic epidural procedures by using abdominal trunk blocks, such as rectus sheath (RS) and transversus abdominis plane (TAP) blocks. The paired rectus abdominis muscles and their anterior and posterior sheaths are the key anatomical landmarks of RSCA.Innervation of the anterior abdominal wall arises from the ventral rami of the thoracic nerves (T6-T11), the subcostal nerve (T12), and first lumbar nerve (iliohypogastric and ilioinguinal nerves). The main application of RSCA is for patients undergoing surgery by giving a midline or para-median abdominal incision. RSCs can be placed before abdominal incision, during surgery with the abdomen open, or after surgery once the abdomen has been closed. RSC insertion must be performed under aseptic conditions. With the patient positioned supine. Manual bolus regimens of 20 ml bupivacaine 0.25% Is given via catheters. We plan a prospective, randomised study to compare post operative analgesic efficacy of Epidural Analgesia and Rectus Sheath Catheter Analgesia in abdominal surgeries under general anaesthesia by taking count on post operative pain score (VAS Score) and analgesic requirements of patients. |