| CTRI Number |
CTRI/2024/04/066406 [Registered on: 26/04/2024] Trial Registered Prospectively |
| Last Modified On: |
23/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia Other (Specify) [Pain relief procedure] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Quality of Pain Relief in Women Undergoing Abdominal Gynaecologic Oncology Surgery |
|
Scientific Title of Study
|
Post-operative Analgesia in Women Undergoing Open Abdominal Gynaecologic Oncology Surgery with or without Ultrasound Guided Bilateral Erector Spinae Plane Block: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjali Gera |
| Designation |
Senior Consultant |
| Affiliation |
Sir Gangaram Hospital, New Delhi |
| Address |
Room No 10 SSRB Block, SGRH, Rajinder Nagar, New Delhi
Central DELHI 110060 India |
| Phone |
9811571080 |
| Fax |
|
| Email |
anjali_chawla@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Anjali Gera |
| Designation |
Senior Consultant |
| Affiliation |
Sir Gangaram Hospital, New Delhi |
| Address |
Room No 10 SSRB Block, SGRH, Rajinder Nagar, New Delhi
Central DELHI 110060 India |
| Phone |
9811571080 |
| Fax |
|
| Email |
anjali_chawla@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Derish David |
| Designation |
DNB Trainee |
| Affiliation |
Sir Gangaram Hospital |
| Address |
Room No 10 SSRB Block, SGRH, Rajinder Nagar, New Delhi
Central DELHI 110060 India |
| Phone |
7012768937 |
| Fax |
|
| Email |
derishdavidukken@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Gangaram Hospital, Rajinder Nagar, New Delhi-110060 |
|
|
Primary Sponsor
|
| Name |
Sir Gangaram Hospital, New Delhi |
| Address |
Institute of Anaesthesiology, Pain and Perioperative Medicine, Sir Gangaram Hospital , Rajinder Nagar, New Delhi, 110060 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 ANJALI GERA |
OT Complex |
Fifth Floor SSRB Building, Sir Ganga Ram Hospital. New Delhi Central DELHI |
9811571080
anjali_chawla@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee Sir Gangaram Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A (ESP) |
Single shot USG guided bilateral Erector spinae plane block will be performed under strict aseptic precautions after induction of GA. |
| Comparator Agent |
Group B (Control) |
Erector spinae plane block will not be administered in this group of patients. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. ASA I-III
2. Patients undergoing elective open abdominal gynaecologic oncology surgery |
|
| ExclusionCriteria |
| Details |
1.Emergency surgery
2.Anomalies of vertebral column
3.Any lesion obscuring sonoanatomy
4.Blood or CSF tap during the procedure
5.Failed blocks
6.Patient on anticoagulants or bleeding diathesis
7.Previous history of local anaesthetic allergy
8.History of obstructive sleep apnoea
9.Patients not consenting to participate in the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total epidural fentanyl consumption |
After 24 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post-operative vitals including heart rate, blood pressure, Post-operative pain using 10cm Visual Analogue Scale (VAS) score, PONV and sedation. |
30min,2hr,4hr,6hr,12hr,24hrs
|
|
|
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)
|
08/05/2024 |
| 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
|
Adequate postoperative analgesia can reduce morbidity and mortality associated with open abdominal gynaecologic oncology surgery by allowing early ambulation, decreasing hospital stay, thromboembolism, and other adverse outcome. Routinely opioids are used for managing post-operative pain relief after major surgery with associated side effects like respiratory depression, nausea, vomiting, constipation and drowsiness. Opioids delivered through epidural route offer advantage of superior pain relief with reduction in the consumption. However, epidural analgesia is associated with adverse effects like hypotension, delayed ambulation, ileus and failed block. USG guided bilateral erector spinae plane block is a comparatively new analgesic modality in thoracic and abdominal surgery which is easy to administer and proposed to have comparable analgesia and decreased complications compared to that with epidural analgesia. This is a randomized controlled study to be conducted among 60 adult females undergoing elective open abdominal gynaecologic oncology surgery under general anaesthesia with patient controlled epidural analgesia (PCEA). Patients will be randomly allocated to two groups (Group A, Group B) of 30 each. Group A will receive ultrasound (USG) guided bilateral erector spinae plane block. Group B will not receive erector spinae plane block. Post-operative consumption of fentanyl via PCEA pump and rescue analgesia with systemic opioids received will be assessed for 24 hours. Post-operative analgesia in terms of visual analogue scale (VAS), haemodynamic changes, sedation, nausea and vomiting will be compared between both the groups. We hypothesise that USG guided bilateral erector spinae plane block could provide adequate post- operative analgesia thereby reducing post-operative fentanyl consumption in women undergoing open abdominal gynaecologic oncologic surgery with lesser side effects. |