| CTRI Number |
CTRI/2020/03/024236 [Registered on: 25/03/2020] Trial Registered Prospectively |
| Last Modified On: |
17/03/2020 |
| 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
|
Comparison of pain relief between two different blocks in patients undergoing inguinal hernia surgery |
|
Scientific Title of Study
|
Analgesic efficacy of Ultrasound guided Erector Spinae Plane Block or Ilioinguinal/ Iliohypogastric nerve block in patients undergoing unilateral inguinal hernia meshplasty - A Randomised Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amitesh Mohan Chugh |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
Government Medical College and Hospital, Sector 32, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care,
D-Block
Level 5
Government Medical College and Hospital, Sector 32
Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
|
| Fax |
|
| Email |
amitesh.inbox@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Richa Saroa |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College and Hospital, Sector 32, Chandigarh |
| Address |
Department of Anaesthesia & Intensive Care
D-Block
Level 5
Government Medical College and Hospital
Sector 32
Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
9646121513 |
| Fax |
|
| Email |
richajayant@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Richa Saroa |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College and Hospital, Sector 32, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care,
D-Block
Level 5
Government Medical College and Hospital, Sector 32
Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
|
| Fax |
|
| Email |
richajayant@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive Care
D-Block
Level 5
Government Medical College and Hospital, Sector 32, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care,
D-Block
Level 5
Government Medical College and Hospital, Sector 32
Chandigarh |
| 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 |
| Amitesh Mohan Chugh |
Government Medical College and Hospital, Sector 32, Chandigarh |
Department of Anaesthesia and Intensive Care,
D-Block
Level 5
Government Medical College and Hospital, Sector 32
Chandigarh
Chandigarh
CHANDIGARH |
9780945019
amitesh.inbox@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, GMCH Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erector Spinae Plane Block |
The patient will be positioned in lateral decubitus position depending upon the site of surgery being done. The area of interest would be draped after cleaning with 10 % povidone iodine. After ensuring full aseptic conditions, a high-frequency (5-10 MHz) linear array ultrasound probe (Sonosite, Inc. Bothell, WA 98021, USA) will be placed in the cranio-cephalad orientation in the midline to identify the spinous process in the upper thoracic area (T4-7). The probe will then be moved laterally on the side of surgery to identify the transverse process which has an oval hyperechoic sonographic appearance. The trapezius, rhomboid major and ESM will be identified superficial to the transverse process. A Sono Plex Stim cannula (21G 100mm, Pajunk, Germany) will be introduced in plane between the ESM and transverse process. After hydrodissection and negative aspiration, an unilateral block with 20 ml of 0.25% ropivacaine will be performed with frequent aspirations. Subsequently the patient will be turned supine and transferred to the post-operative care unit (PACU). The observations as mentioned below will be recorded in the prescribed proforma and subjected to statistical analysis at the end of the study. |
| Comparator Agent |
Ilioinguina/Iliohypogastric nerve block |
A linear high frequency ultrasound transducer will be placed over the anterior superior iliac spine identified by palpation before placing the probe. The superior margin of the transducer will be pointed directly in an oblique plane toward the umbilicus and then rotated superiorly and inferiorly until the fascial plane between the internal oblique and transverse abdominis muscle is identified. The ovoid hypoechoic ilioinguinal nerve will be identified within this fascial plane. The iliohypogastric nerve will also be identified medial to the ilioinguinal nerve within the fascial plane. Color Doppler image will be utilized, if required, to identify the deep circumflex iliac artery which lies in close proximity to the ilioinguinal nerve to avoid inadvertent arterial puncture. A Sono Plex Stim cannula (21G 100mm, Pajunk, Germany) will be introduced in plane and 20 ml of 0.2 % ropivacaine will be deposited in close vicinity of both the nerves after frequent negative aspirations. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age group 18 to 65 years
Patient belonging to American Society of Anaesthesiology (ASA) physical status 1 and 2
Elective surgery for unilateral inguinal hernia (open meshplasty)
|
|
| ExclusionCriteria |
| Details |
Patient refusal
Recurrent hernia
Inguino-Scrotal or Sliding hernia
Allergy to local anaesthetics
Infection at block injection site
Opioid dependence
Chronic Pain
Coagulopathy
Patient with severe pulmonary disease, cardiac disease
Pre-existing neurological deficits
Dementia
Pregnancy
Contraindication to Subarachnoid Block
Inability to comprehend pain scale or use PCA device
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the comparative reduction in pain intensity by use of linear visual analogue scale (VAS) in post-operative period in patients receiving ultrasound guided erector spinae block or Ilioinguinal/iliohypogastric nerve block following unilateral open mesh hernioplasty
|
30min, 1hr, 4hr, 8hr, 12hr, 24hr
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time to first rescue analgesic
|
24 hours |
To calculate and compare the cumulative morphine consumption over 24 hours in post- operative period in both the groups.
|
24 hours |
To calculate and compare the total dose of antiemetics over 24 hours in both the groups.
|
24 hours |
To note any side effects pertaining to the procedure or the drugs used in the present study.
|
24 hours |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/04/2020 |
| 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)?
|
|
Brief Summary
|
Erector Spinae Plane (ESP) block is a more recent regional anaesthetic technique use to provide post-operative pain relief, both acute and chronic, for various surgical procedures. As this is a relatively newer block, its beneficial prospects in a variety of procedures are yet to be explored with many trials and studies ongoing Presently, the literature available on ESP block is deficient in describing its utility in inguinal hernia patients, especially adults. There is limited evidence available on the advantages of ESP block, but we hypothesise that based on the simplicity of identification and administration, lower risk of adverse events as tissue plane is away from major neurovascular bundles and pleura, it has significant advantages over other methods currently employed for pain management in inguinal hernia surgeries. Also IIN/IHN block has been found to provide adequate analgesia after hernioplasty. Although ultrasound guided interfascial blocks have been utilized in hernioplasty for providing adequate post-operative analgesia, however limited literature is available in comparing the analgesic efficacy between ESP block and IIN/IHN block in patients undergoing unilateral inguinal hernia repair. We hypothesise that ESP block or IIN/IHN block may be equivalent or either of the block may prove to be more efficacious in providing adequate and effective post-operative analgesia in patients undergoing unilateral mesh hernioplasty under subarachnoid block. Hence, the present study is being undertaken to compare the efficacy of Ultrasound guided ESP block with ultrasound-guided Ilioinguinal/Iliohypogastric nerve block for post-operative analgesia in patients scheduled to undergo elective unilateral inguinal hernia meshplasty. |