| CTRI Number |
CTRI/2024/07/070082 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of External Oblique plane block and Erector Spinae plane block in pain control after kidney removal surgery |
|
Scientific Title of Study
|
Comparison of analgesic efficacy between External Oblique plane block and Erector Spinae plane block in adult patients undergoing Laparoscopic Nephrectomy : A Randomised 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 |
Beenu Alex |
| Designation |
Junior resident |
| Affiliation |
AIIMS Patna |
| Address |
Department of Anaesthesiology, 5th floor OT complex, IPD building, AIIMS Patna, Phulwari Sharif, Patna, Bihar
Patna
BIHAR
801507
India |
| Phone |
7994331248 |
| Fax |
|
| Email |
beenualex@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajnish Kumar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Patna |
| Address |
Department of Anaesthesiology, 5th floor OT complex, IPD building, AIIMS Patna, Phulwari Sharif, Patna, Bihar
Patna
BIHAR
801507
India |
| Phone |
7783865337 |
| Fax |
|
| Email |
drrajnishkumar@aiimspatna.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajnish Kumar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Patna |
| Address |
Department of Anaesthesiology, 5th floor OT complex, IPD building, AIIMS Patna, Phulwari Sharif, Patna, Bihar
Patna
BIHAR
801507
India |
| Phone |
7783865337 |
| Fax |
|
| Email |
drrajnishkumar@aiimspatna.org |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Patna, Bihar, India, 801507 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Patna |
| Address |
Department of Anaesthesiology, 5th floor OT complex, IPD building, AIIMS Patna |
| Type of Sponsor |
Government 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 |
| Dr Rajnish Kumar |
All India Institute of Medical Sciences, Patna |
Department of Anaesthesiology, 5th floor OT Complex, IPD Building, AIIMS Patna,
Patna
BIHAR |
7783865337
drrajnishkumar@aiimspatna.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Patna |
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 |
| Comparator Agent |
Erector Spinae plane block |
Single dose of 20 ml 0.2 % Ropivacaine given in Erector Spinae plane. |
| Intervention |
External Oblique plane block |
Single dose of 20 ml 0.2 % Ropivacaine given in External oblique plane |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists PS I-III.
Adult patients undergoing Laparoscopic Nephrectomy.
Patients willing to give written informed consent.
|
|
| ExclusionCriteria |
| Details |
History of allergy to the study drugs
Coagulopathy
Local infection
Body mass index more than 35
History of chronic pain
History of regular opioid use
Inability to comprehend NRS and PCA
Cases converted to open nephrectomy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare 24 hour Fentanyl consumption post operatively in External Oblique Plane Block group and Erector Spinae Plane Block group. |
24 hour post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare Intraoperative opioid consumption in both groups. |
intra operatively |
| Time to first rescue analgesia. |
within 24 hours post operatively |
| Number of doses attempted by patient for rescue analgesia |
within 24 hours postoperatively |
| Numerical Pain rating scale at 1hr, 2hr, 3hr, 6hrs 12 hrs and 24hrs. |
within 24 hours post operatively |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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
Modification(s)
|
N/A |
|
Date of First Enrollment (India)
|
11/07/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The laparoscopic method is frequently employed in nephrectomy over traditional open surgeries due to several benefits, including smaller incisions and quicker recovery. But there can be significant postoperative pain resulting from pneumoperitoneum and kidney manipulations during surgery. Such pain and stress reactions can exacerbate patients’ conditions, raise the risk of complications, and lengthen recovery periods. Perioperative analgesic agents, opioids in particular, are extensively employed. However, they come with a diverse range of side effects, including nausea, vomiting, respiratory depression, delayed gastric emptying, ileus, and pruritus. The thoracic epidural block, regarded as the gold standard, is frequently linked to sympathetic blockade (resulting in hypotension). Additionally, it carries the risk of dura puncture and the risk of hematoma and cord compression in individuals with coagulopathy. Hence, a regional analgesia technique such as the external oblique plane block or erector spinae plane block may be considered as viable alternatives, offering potential advantages in pain management while minimizing the associated risks and side effects observed with opioids and thoracic epidural blocks, and improving postoperative recovery quality. Here in this study we compare External Oblique plane block, which is a superficial block, which can be done in supine position, with easy identifiability even in obese patients , with needle insertion site far away from vascular bed and Erector Spinae plane block which is a paravertebral block, with potential epidural spread of local anaesthetic and sympathetic blockade and hemodynamic instability , in pain management after laparoscopic nephrectomy. If found effective , External Oblique plane block can be an alternative to Erector spinae plane block for pain management in laparoscopic nephrectomy. |