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The efficacy of the ultrasound-guided retrolaminar block versus the classic paravertebral block in patients undergoing unilateral inguinal hernioraphy: a randomized controlled study

Protocol summary

Study aim
Evaluate the postoperative analgesic effects of ultrasound-guided retrolaminar block versus the classic paravertebral block in patients scheduled for elective open inguinal hernioraphy.
Design
A concealed, Prospective, blinded randomized clinical trial. Two parallel group ,25 patient in each, enrolled between January 2023, and March 2023, and followed for 24 hours.
Settings and conduct
In Mansoura university hospital , both techniques will be performed after induction of anesthesia by a single operator, ultrasound-guided using 17-gauge, 80 mm, Tuohy needle (Univer;Unisis, Tokyo, Japan). In both groups, the spinous process of T12 will be identified ,the patient in the lateral position. We will scan the paramedian anatomical landmarks of T12, ipsilateral to the surgical side, using an 8-13MHz linear array ultrasound transducer probe
Participants/Inclusion and exclusion criteria
Inclusion criteria • Age between 20 and 60 years and prepared for elective unilateral inguinal hernioraphy. ,American Society of anesthesiologists (ASA) I or II. Exclusion criteria Age beyond the previously mentioned limits ,patients refusal ,ASA > II. ,having contraindications for the study medications ,Infections at block site ,morbid obesity ,history of substance abuse ,history of allergy to local analgesics ,mental dysfunction, Metabolic disease, using anticoagulants.
Intervention groups
Retrolaminar block (RLB)(n=25) will include 25 cases who will receive 20ml of bupivacaine 0.25% , will be injected ultra-sound guided into the retrolaminar space between the lamina of T12 and the paraspinal muscles Paravertebral block(PVB)(n=25) will include the other 25 cases who will receive 20ml of bupivacaine 0.25% ,will be injected ultra-sound guided into the paravertebral space at level of T12.
Main outcome variables
• Number of patients who needed rescue analgesia (morphine) in the first 24 h.

General information

Reason for update
Acronym
RLB
IRCT registration information
IRCT registration number: IRCT20220212054002N2
Registration date: 2023-01-25, 1401/11/05
Registration timing: prospective

Last update: 2023-01-25, 1401/11/05
Update count: 0
Registration date
2023-01-25, 1401/11/05
Registrant information
Name
zenat eldadamony
Name of organization / entity
Mansoura university
Country
Egypt
Phone
+20 122 543 9066
Email address
zenatddd@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-30, 1401/11/10
Expected recruitment end date
2023-05-30, 1402/03/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of the ultrasound-guided retrolaminar block versus the classic paravertebral block in patients undergoing unilateral inguinal hernioraphy: a randomized controlled study
Public title
Retrolaminar block in unilateral inguinal hernioraphy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 and 60 years and prepared for elective unilateral inguinal hernioraphy. American Society of anesthesiologists (ASA) I or II.
Exclusion criteria:
Patients refusal ASA > II. Patients refusal h aving contraindications for the study medications. Infections at block site. History of substance abuse. Mental dysfunction. Metabolic disease Using anticoagulants.
Age
From 20 years old to 60 years old
Gender
Male
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Enrolled patients will randomly allocated to group (RLB) and group (PVB) with allocated ratio 1:1 .Randomization will done before surgery by computer generated random ,Version28.0 . Opaque sealed sequentially numbered envelopes containing the patients` codes will used and opened just before anesthesia by physician who will not involved in the study . The patients will be allocated to either group “RLB”, who receive retrolaminar block , or group “PVBB” who receive paravertebral block , with general anesthesia
Blinding (investigator's opinion)
Double blinded
Blinding description
Anesthesiologist who will perform the block will not be blinded to group assignment. However, anesthesiologist responsible of the patient and health care providers who collected the data will be blinded to group allocation.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Institutional Research Board
Street address
Algomhouria street
City
Mansoura
Postal code
35511
Approval date
2023-01-02, 1401/10/12
Ethics committee reference number
R.22.12.2001.R1

Health conditions studied

1

Description of health condition studied
Post operative pain control in unilateral inguinal hernia repair
ICD-10 code
K40
ICD-10 code description
Inguinal hernia

Primary outcomes

1

Description
Number of patients who needed rescue analgesia (morphine) in post operative
Timepoint
24 hour post operative period
Method of measurement
Visual Analogue Scale to measure pain

Secondary outcomes

1

Description
Mean blood pressure ,and Heart rate
Timepoint
Basal(0), At skin incision, During sac traction, and At end of surgery.
Method of measurement
Sphygmomonometer

2

Description
Post-operative pain
Timepoint
Immediate post-operative (0) and At 2, 4,6,8,12,24 h post-operative.
Method of measurement
Visual Analogue Scale

Intervention groups

1

Description
Control group:(BVB) patient will include the other 25 cases who will receive 20 ml of bupivacaine 0.25%, will be injected ultra-sound guided into the ipsilateral paravertebral space at level of T12
Category
Treatment - Other

2

Description
Intervention group: (RLB) patient will receive 20 ml of bupivacaine 0.25%, will be injected ultra-sound guided into the ipsilateral retrolaminar space between the lamina of T12 and the paraspinal muscles
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mansoura university hospital
Full name of responsible person
Zenat Eldadamony MOHAMED
Street address
Algomhouria street
City
Mansoura
Postal code
35511
Phone
+20 100 726 8585
Email
zenatddd@gmail.com
Web page address
http://www.mans.edu.eg

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mansoura university hospital
Full name of responsible person
Zenat Eldadamony Mohamed
Street address
Algomhouria street
City
Mansoura
Postal code
35511
Phone
+20 100 726 8584
Email
zenatddd@gmail.com
Web page address
http://www.mans.edu.eg
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mansoura university hospital
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mansoura university hospital
Full name of responsible person
Zenat Eldadamony Mohamed
Position
lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Anesthesiology
Street address
Algomhouria street
City
Mansoura
Province
Mansoura
Postal code
35511
Phone
+20 100 726 8584
Email
zenatddd@gmail.com
Web page address
http://www.mans.edu.eg

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mansoura university hospital
Full name of responsible person
Zenat Eldadamony Mohamed
Position
Mansoura
Latest degree
Ph.D.
Other areas of specialty/work
Anesthesiology
Street address
Algomhouria street
City
Mansoura
Province
Mansoura
Postal code
35511
Phone
+20 100 726 8584
Email
zenatddd@gmail.com
Web page address
http://www.mans.edu.eg

Person responsible for updating data

Contact
Name of organization / entity
Mansoura university hospital
Full name of responsible person
Zenat Eldadamony Mohamed
Position
lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Anesthesiology
Street address
Algomhouria street
City
Mansoura
Province
Mansoura
Postal code
35511
Phone
+20 100 726 8584
Email
zenatddd@gmail.com
Web page address
http://www.mans.edu.eg

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
IPD primary outcome measure only
When the data will become available and for how long
6 month after published
To whom data/document is available
Academic institutions or businesses
Under which criteria data/document could be used
Comparison
From where data/document is obtainable
Email addresses zenatddd@gmail.com
What processes are involved for a request to access data/document
Request by Email
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