Ignite Creation Date:
2024-05-06 @ 3:26 AM
Last Modification Date:
2024-10-26 @ 11:34 AM
Study NCT ID:
NCT02299908
Status:
UNKNOWN
Last Update Posted:
2014-11-24
First Post:
2014-11-17
Brief Title:
Ultrasound-guided Transverses Abdominis Plane Block in Inguinal Herniorrhaphy Randomized Controlled Clinical Trial
Sponsor:
Patricia Salazar Villegas
Organization:
Universidad de Caldas
Study Overview
Official Title:
Ultrasound-guided Transverses Abdominis Plane Block in Inguinal Herniorrhaphy Randomized Controlled Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2014-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Acute postoperative pain is one of the most important centers of therapeutic attention in postoperative phase of any procedure It is a complex entity that requires a multiple intervention to be treated and depending on the intervened surgical site it has different approaches
Despite attempts to reduce postoperative pain by implementing management protocols rates of pain prevalence from moderate acute to severe pain are still reported as high as 50 in the first 24 postoperative hours Among the surgeries that report greater intensity of postoperative pain is open inguinal Herniorrhaphy That is why several techniques have been described for the management of acute pain in this surgery postoperative among which PAT blocking has shown to be beneficial in some studies However some reports question its usefulness but with the emergence of ultrasound-guided techniques for its realization interest in this blockage has grown back
This study aims to demonstrate the utility of the PAT blocking in the management of acute pain of pre-peritoneal inguinal herniorrhaphy with mesh
Despite attempts to reduce postoperative pain by implementing management protocols rates of pain prevalence from moderate acute to severe pain are still reported as high as 50 in the first 24 postoperative hours Among the surgeries that report greater intensity of postoperative pain is open inguinal Herniorrhaphy That is why several techniques have been described for the management of acute pain in this surgery postoperative among which PAT blocking has shown to be beneficial in some studies However some reports question its usefulness but with the emergence of ultrasound-guided techniques for its realization interest in this blockage has grown back
This study aims to demonstrate the utility of the PAT blocking in the management of acute pain of pre-peritoneal inguinal herniorrhaphy with mesh
Detailed Description:
1 Patient registry
The cases will be recorded by an external agent who will verify compliance with the protocol by the treating physicians surgeons and anesthesiologists additionally this agent will interview patients for the processing of the instrument and will also collect the proper information of the procedure At random and in an unannounced way visits will be made to the centers of attention to verify that the procedure was done according to what had been agreed
Additionally when the full record of the patients is registered in a database they will be called one by one to confirm the information collected Further records are sought in the systematized medical history in order to verify additional information
a Quality assurance plan i Each record will be completed by an external agent to the surgical procedure who will be trained for this work according to the methodological design of the study
ii Regular visits are made to the information collection site to confirm compliance with attention and randomization protocols
iii Information collected on the instrument will be confirmed with each patients the clinical history
b Data verification for range and consistency i Each of the instruments for each unit of analysis will be typed in a database by the same person who will be trained in the methodological design of the study who will monitor that each variable has been collected according to the categories previously established for that variable
ii One second revision of the database will be carried out by one of the researchers who will review column by column categories so that they are consistent with the predefined rules for that range Additionally compatibility between these categories and other categories of variables that must be compatible will be verified For example the hour of completion of surgery is later than the start time etc
c Verification of data for Accuracy Completeness and Representativeness i Each instrument collected will be verified with surgical description carried out by the surgeon anesthesia report made by the anesthesiologist and medical developments made by the hospital physician in charge of patient care in the postoperative period In case of finding any inconsistency the confirmation of the information will proceed through an additional call to the patient and the treating specialists if necessary
ii Record of the patients inclusion in the protocol of the clinical trial guiding the treating physicians in the active pursuit of the variables under study will be included in all electronic medical records
d Data Dictionary
Consecutive Unique number for each unit of analysis Source Patient Code Does not apply Ranges 1 2 3 4 5 and so on Type Organization
Date Day month and year in which the surgery is carried out Source Medical history Code Does not apply Ranges Day 1 a 31 Month 1 a 12 Year 2015 Type Organization
Age Age at time of surgery Source Identification Number Code Does not apply Ranges 18 19 20 and so on Type Base
Sex Gender Source Patient Code Does not apply Ranges Male Female Type Base
Social Stratum Economic level Source Patient Code Does not apply Ranges 1 2 3 4 5 6 Type Base
Education Educational level Source Patient Code Does not apply Ranges None Primary School Secondary School technical technological professional specialist Masters Doctoral degree Type Base
Laterality Side of hernia Source Patient Code Does not apply Ranges Right Left Type Base
ASA Surgical risk Source Medical history Code Does not apply Ranges 1 2 3 4 5 Type Clinic
Weight Weight in kilograms Source Medical history Code Does not apply Ranges 30 31 32 and so on Type Base
Height Height in meters Source Medical history Code Does not apply Ranges 14 141 142 and so on Type Base
Background Diseases that the patient has Source Medical history and patient Code Does not apply Ranges Asthma chronic obstructive pulmonary disease COPD hypertension diabetes heart failure etc Type Clinic
Lockout duration Block performance time minutes Source Surgery room Code Does not apply Ranges 2 3 4 5 and so on Type Anesthetic
Duration of surgery Surgery completion time minutes Source Surgery room Code Does not apply Ranges 15 16 17 and so on Type Surgical
Adverse Reactions Side effects and complications Source Surgery room Code Does not apply Ranges Hypotension bradycardia arrhythmias aspiration of blood viscera perforation hematoma femoral nerve block infiltration resistance Type Primary result
Realization Specialist who performed the lock Source Surgery room Code Does not apply Ranges 1 2 Type Anesthetic
Pain 1 Visual Analog Scale VAS when anesthetic medication suspended Source Patient Code Does not apply Ranges 1 2 3 4 5 6 7 8 9 10 Type Primary result
Rescue 1 Number of rescue doses of morphine applied early after anesthetics have been suspended Source Recovery nurse Code Does not apply Ranges 1 2 3 4 and so on Type Secondary result
Adverse effect 1 Adverse effect presented early after anesthetics is suspended Source Recovery nurse Code Does not apply Ranges Vomiting nausea itching dry mouth drowsiness respiratory depression none other Type Secondary result
Pain 2 VAS 24 hours after anesthetic medication is suspended Source Patient Code Does not apply Ranges 1 2 3 4 5 6 7 8 9 10 Type Primary result
Rescue 2 Number of rescue tramadol dosage applied between the first hour and 24-hour after anesthetic is suspended Source Patient Code Does not apply Ranges 1 2 3 4 and so on Type Secondary result
Adverse effect 2 Adverse effect occurred between first hour and 24-hours after anesthetic is suspended Source Patient Code Does not apply Ranges Vomiting nausea itching dry mouth drowsiness respiratory depression none other Type Secondary result
Intervention Application of local PAT anesthetic Source Currency format Randomization Code Does not apply Ranges Yes Intervention No Placebo Type Intervention
e Standard Operation Procedures i Registration operation
1 Patient Recruitment
1 All patients scheduled for inguinal herniorrhaphy by the surgeon will be reported by the administrative programming group to the researchers who will attend the preoperative evaluation by anesthesiology to practice informed consent and inclusion and exclusion criteria Patients that can continue with the protocol will be included in the study
2 The day of the surgery the surgical instrumentation group will perform the patients randomization with a consecutive identification number and without knowing the patient will take to the operating room the substance to apply in the PAT
2 Data collection
1 During surgery a research assistant who is blind to the applied substance shall record the data collection instrument based on what he observes in the operating room and on what he questions in the first hour after the suspension of anesthetics in the post-anesthesia care room
2 After 24 hours of suspending the anesthetic the research assistant will call the patient to question him about the necessary information to complete the data collection instrument of
3 Data management
1 The missing information in the database will be completed through review of medical records interview with the surgeon anesthesiologist and unit post-anesthesia care nurse The information still needed will be supplemented through a call to the patient If despite the above it is not possible to get the required information the case will be withdrawn for further analysis by intention to treat
2 Visits audits and random checks to confirm the effectiveness of the data collection will be made
ii Analysis Activities
-- --
1 Data analysis
Information of the instruments will be typed for the development of a database which will be complemented by the intervention variable the day determined to collect the sample After that it will be delivered to the researchers who will undertake the analysis and interpretation so that later they can make the socialization of results
2 Adverse effects report
Whenever an adverse outcome is evidenced it will be reported to the researchers and treating physicians surgeon and anesthesiologist Additionally the patient will be informed Likewise it will be notified on clinical trial data base
3 Change management
1 If it is necessary to make a change to the protocol or data collection researchers will meet to discuss the best option which does not affect the overall outcome of the investigation but also which does not put in an additional hazard the patients safety When this aspect is defined a statement to the entire group of research will be issued
2 If a severe and frequent adverse reaction occurs the possibility to suspend the controlled clinical trial will be determined between the researchers and the medical ethics committee
f Evaluation of the sample size
i Number of participants The sample size was calculated using the formula for mean difference in analytical studies with a confidence index of 95 a margin of error of 5 a statistical power of 80 a variance of 10 and a minimum differential detection value of 28 compared to which a sample of 40 patients was obtained With a loss rate of 10 the sample size was expanded to 44 patients
ii Years participated Since it is an acute pain study 24 hours were determined to monitor
g Missing data plan
i Missing data will be completed with clinical history interview o professionals involved with patient care calls and or visits to patients If data loss remains an analysis by intention to treat will proceed
h Statistic analysis plan i Frequency distribution and qualitative variables association tables will be made statistical significance for p values less than 005 will be determined association between intervention variable and primary outcome and secondary outcome variables will be sought using for t his purpose the statistics analysis plan
The cases will be recorded by an external agent who will verify compliance with the protocol by the treating physicians surgeons and anesthesiologists additionally this agent will interview patients for the processing of the instrument and will also collect the proper information of the procedure At random and in an unannounced way visits will be made to the centers of attention to verify that the procedure was done according to what had been agreed
Additionally when the full record of the patients is registered in a database they will be called one by one to confirm the information collected Further records are sought in the systematized medical history in order to verify additional information
a Quality assurance plan i Each record will be completed by an external agent to the surgical procedure who will be trained for this work according to the methodological design of the study
ii Regular visits are made to the information collection site to confirm compliance with attention and randomization protocols
iii Information collected on the instrument will be confirmed with each patients the clinical history
b Data verification for range and consistency i Each of the instruments for each unit of analysis will be typed in a database by the same person who will be trained in the methodological design of the study who will monitor that each variable has been collected according to the categories previously established for that variable
ii One second revision of the database will be carried out by one of the researchers who will review column by column categories so that they are consistent with the predefined rules for that range Additionally compatibility between these categories and other categories of variables that must be compatible will be verified For example the hour of completion of surgery is later than the start time etc
c Verification of data for Accuracy Completeness and Representativeness i Each instrument collected will be verified with surgical description carried out by the surgeon anesthesia report made by the anesthesiologist and medical developments made by the hospital physician in charge of patient care in the postoperative period In case of finding any inconsistency the confirmation of the information will proceed through an additional call to the patient and the treating specialists if necessary
ii Record of the patients inclusion in the protocol of the clinical trial guiding the treating physicians in the active pursuit of the variables under study will be included in all electronic medical records
d Data Dictionary
Consecutive Unique number for each unit of analysis Source Patient Code Does not apply Ranges 1 2 3 4 5 and so on Type Organization
Date Day month and year in which the surgery is carried out Source Medical history Code Does not apply Ranges Day 1 a 31 Month 1 a 12 Year 2015 Type Organization
Age Age at time of surgery Source Identification Number Code Does not apply Ranges 18 19 20 and so on Type Base
Sex Gender Source Patient Code Does not apply Ranges Male Female Type Base
Social Stratum Economic level Source Patient Code Does not apply Ranges 1 2 3 4 5 6 Type Base
Education Educational level Source Patient Code Does not apply Ranges None Primary School Secondary School technical technological professional specialist Masters Doctoral degree Type Base
Laterality Side of hernia Source Patient Code Does not apply Ranges Right Left Type Base
ASA Surgical risk Source Medical history Code Does not apply Ranges 1 2 3 4 5 Type Clinic
Weight Weight in kilograms Source Medical history Code Does not apply Ranges 30 31 32 and so on Type Base
Height Height in meters Source Medical history Code Does not apply Ranges 14 141 142 and so on Type Base
Background Diseases that the patient has Source Medical history and patient Code Does not apply Ranges Asthma chronic obstructive pulmonary disease COPD hypertension diabetes heart failure etc Type Clinic
Lockout duration Block performance time minutes Source Surgery room Code Does not apply Ranges 2 3 4 5 and so on Type Anesthetic
Duration of surgery Surgery completion time minutes Source Surgery room Code Does not apply Ranges 15 16 17 and so on Type Surgical
Adverse Reactions Side effects and complications Source Surgery room Code Does not apply Ranges Hypotension bradycardia arrhythmias aspiration of blood viscera perforation hematoma femoral nerve block infiltration resistance Type Primary result
Realization Specialist who performed the lock Source Surgery room Code Does not apply Ranges 1 2 Type Anesthetic
Pain 1 Visual Analog Scale VAS when anesthetic medication suspended Source Patient Code Does not apply Ranges 1 2 3 4 5 6 7 8 9 10 Type Primary result
Rescue 1 Number of rescue doses of morphine applied early after anesthetics have been suspended Source Recovery nurse Code Does not apply Ranges 1 2 3 4 and so on Type Secondary result
Adverse effect 1 Adverse effect presented early after anesthetics is suspended Source Recovery nurse Code Does not apply Ranges Vomiting nausea itching dry mouth drowsiness respiratory depression none other Type Secondary result
Pain 2 VAS 24 hours after anesthetic medication is suspended Source Patient Code Does not apply Ranges 1 2 3 4 5 6 7 8 9 10 Type Primary result
Rescue 2 Number of rescue tramadol dosage applied between the first hour and 24-hour after anesthetic is suspended Source Patient Code Does not apply Ranges 1 2 3 4 and so on Type Secondary result
Adverse effect 2 Adverse effect occurred between first hour and 24-hours after anesthetic is suspended Source Patient Code Does not apply Ranges Vomiting nausea itching dry mouth drowsiness respiratory depression none other Type Secondary result
Intervention Application of local PAT anesthetic Source Currency format Randomization Code Does not apply Ranges Yes Intervention No Placebo Type Intervention
e Standard Operation Procedures i Registration operation
1 Patient Recruitment
1 All patients scheduled for inguinal herniorrhaphy by the surgeon will be reported by the administrative programming group to the researchers who will attend the preoperative evaluation by anesthesiology to practice informed consent and inclusion and exclusion criteria Patients that can continue with the protocol will be included in the study
2 The day of the surgery the surgical instrumentation group will perform the patients randomization with a consecutive identification number and without knowing the patient will take to the operating room the substance to apply in the PAT
2 Data collection
1 During surgery a research assistant who is blind to the applied substance shall record the data collection instrument based on what he observes in the operating room and on what he questions in the first hour after the suspension of anesthetics in the post-anesthesia care room
2 After 24 hours of suspending the anesthetic the research assistant will call the patient to question him about the necessary information to complete the data collection instrument of
3 Data management
1 The missing information in the database will be completed through review of medical records interview with the surgeon anesthesiologist and unit post-anesthesia care nurse The information still needed will be supplemented through a call to the patient If despite the above it is not possible to get the required information the case will be withdrawn for further analysis by intention to treat
2 Visits audits and random checks to confirm the effectiveness of the data collection will be made
ii Analysis Activities
-- --
1 Data analysis
Information of the instruments will be typed for the development of a database which will be complemented by the intervention variable the day determined to collect the sample After that it will be delivered to the researchers who will undertake the analysis and interpretation so that later they can make the socialization of results
2 Adverse effects report
Whenever an adverse outcome is evidenced it will be reported to the researchers and treating physicians surgeon and anesthesiologist Additionally the patient will be informed Likewise it will be notified on clinical trial data base
3 Change management
1 If it is necessary to make a change to the protocol or data collection researchers will meet to discuss the best option which does not affect the overall outcome of the investigation but also which does not put in an additional hazard the patients safety When this aspect is defined a statement to the entire group of research will be issued
2 If a severe and frequent adverse reaction occurs the possibility to suspend the controlled clinical trial will be determined between the researchers and the medical ethics committee
f Evaluation of the sample size
i Number of participants The sample size was calculated using the formula for mean difference in analytical studies with a confidence index of 95 a margin of error of 5 a statistical power of 80 a variance of 10 and a minimum differential detection value of 28 compared to which a sample of 40 patients was obtained With a loss rate of 10 the sample size was expanded to 44 patients
ii Years participated Since it is an acute pain study 24 hours were determined to monitor
g Missing data plan
i Missing data will be completed with clinical history interview o professionals involved with patient care calls and or visits to patients If data loss remains an analysis by intention to treat will proceed
h Statistic analysis plan i Frequency distribution and qualitative variables association tables will be made statistical significance for p values less than 005 will be determined association between intervention variable and primary outcome and secondary outcome variables will be sought using for t his purpose the statistics analysis plan
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None