Ignite Creation Date:
2024-05-06 @ 6:18 PM
Last Modification Date:
2024-10-26 @ 2:45 PM
Study NCT ID:
NCT05610371
Status:
COMPLETED
Last Update Posted:
2022-11-09
First Post:
2022-10-23
Brief Title:
Intrauterine Anesthesia in Operative Awake Office Hysteroscopy A Randomized Double-blind Placebo-controlled Trial
Sponsor:
Assuta Ashdod Hospital
Organization:
Assuta Ashdod Hospital
Study Overview
Official Title:
Intrauterine Anesthesia in Operative Awake Office Hysteroscopy A Randomized Double-blind Placebo-controlled Trial
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
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:
Objective to evaluate intrauterine lidocaine infusion effectiveness in reducing pain associated with operative awake office hysteroscopy Methods A total of 100 patients will be randomized for this study The control group underwent hysteroscopy using a saline distension medium The study group underwent hysteroscopy using 10ml of 2 lidocaine that was added to the first liter of distension medium Patients quantified their pain using a 0-10 VAS score at the following five predefined points baseline before the procedure while inserting the hysteroscope through the cervix during the operative procedure immediately after the procedure and 15 minutes following the procedure
Detailed Description:
1 Background
Ambulatory hysteroscopy is a safe feasible and accurate procedure for diagnosing and treating intrauterine pathology 1
Office hysteroscopy does not require hospital admission preparatory tests and general anesthesia Importantly it has decreased postsurgical recovery period global cost of the procedure and rate of complications 2 New approaches have evolved due to technological advances in instrumentation an office hysteroscopy that combines diagnosis and treatment of the pathology into a single clinical procedure is referred to as See and Treat hysteroscopy SATH 3
SATH allows diagnosis of different conditions affecting the uterine cavity in an office setting followed immediately with treatment to resolve them thus avoiding the patient having to undergo a subsequent procedure 4
Pain during or after the procedure can discourage patients from undergoing office diagnostic hysteroscopy or SATH 5 and remains a significant cause for failure to complete the procedure
The type of anesthesia used depends on the procedure the patients level of anxiety and the anesthesiologists expertise Simple diagnostic procedures can be performed without anesthesia with a para-cervical block or with mild sedation In a meta-analysis reviewing 36 studies only para-cervical block demonstrated a significant anesthetic effect Munro There is controversy about anesthesia and analgesia for outpatient hysteroscopy as there is not enough high-quality evidence and marked heterogeneity between trials makes it very difficult to draw generalizable conclusions
In a recent study we have evaluated the effect of distension medium composed of 09 saline solution with Lidocaine vs Saline alone and its effect on pain in diagnostic hysteroscopy No studies had been published regarding this method of analgesia in SATH and its effect on pain during the procedure and immediately following the procedure
2 Aims
The primary aim of the current study is to evaluate the effect of local instillation of lidocaine in relieving pain during office SATH hysteroscopy
Secondary aims include the rate of failure in performing the procedure and patient satisfaction among patients in the study group vs controls
3 Hypothesis
In this prospective randomized double blind study utilizing adult women undergoing office SATH hysteroscopy local instillation of lidocaine in the distension media should reduce the pain during and following the procedure by 20 and also improve patient satisfaction and might reduce failure rates without an increase in complication rates
4 Settings and participants
All patients referred to a diagnostic office SATH hysteroscopy at the outpatient clinics in Assuta Ashdod University Hospital that fit the inclusion criteria
Inclusion criteria
Women between the ages of 20 years - 52 years inclusive
Undergoing SATH office hysteroscopy
Patients are able to provide written consent
Exclusion criteria
Previous Pelvic Inflammatory Disease PID or documented tubal occlusion
Inability to consent due to cognitive or language barrier
Allergy to Lidocaine
Documented failed hysteroscopy prior to the current referral
5 Study methodology and techniques
Study Design
This study is a prospective randomized double blind trial
Women undergoing SATH office hysteroscopy that are eligible for the study will be divided into 2 groups
1 Hysteroscopy using saline alone as a distension medium
2 Hysteroscopy using a 10 ml of 2 lidocaine in a 1000 ml of saline as a distension medium The distension medium bags will be prepared by the Assuta Ashdod University Hospital Pharmacy The first bag will contain 10 ml of 2 lidocaine in a 1000 ml of saline or saline alone and will be coded using a serial number and randomized using computerized software Each patient will be allocated 3 distension media bags THE second an third one will contain saline alone The investigators and patients will be blinded to the composition of the distension medium
A sample size of 100 patients to allow for 10 attrition providing a net total of 45 per groups as described below at a 11 ratio will be included in each group and will complete a questionere prior to and following the procedure Appendix 1 A schematic overview of the research is displayed in figure 1 summarizing the patients participation during each stage of the research Data will be analyzed and the effect of Lidocaine addition to the distension medium will be evaluated
Patients who withdrew from the study will be analyzed as intention to treat patients
6 Recruitment Strategy
Patients will be recruited from the population of patients referred to the outpatient hysteroscopy clinics at Assuta Ashdod University Hospital The investigator will inform the patient about the study its purpose and method of randomization of study groups Patients will not be cajoled into participating in this study The Investigator will discuss foreseeable risks involved as well as potential benefits for each study group Patients who have consented to having their information obtained during the study for analysis of the results will have their confidentiality maintained at all times using a study code as an identifier in the research database The patients will be informed by the Investigator that their medical treatment will not be affected in any mean by their decision whether to participate or not in the study Patients will be informed that they may choose to withdraw from the study at any stage without jeopardizing any further medical care A signed and dated Informed Consent must be obtained by the Investigator from the patient prior to enrolment into this study The original signed and dated information sheet and patient consent will be kept by the Investigator A signed copy will be provided to the patient
7 Data Collection Plan
Demographics age ethnicity
Weight in kg height in cm
Medical gynecological and surgical history
VAS pain score prior to the procedure
Indication for hysteroscopy
Success in performing the procedure Length of the procedure and surgical complications
Hysteroscopic findings
Serial number appearing on the distension medium ampule
VAS score following the procedure
Patient satisfaction score 1-10
Free text regarding the procedure and other patient comments
8 Cost of study
Cost of intervention will be determined by considering the following factors
Cost of pharmaceutical preparation of the distension media and randomization - will be performed by the hospital pharmacy at no cost
Cost of statistical analysis
9 Timing of endpoint measurements
All data recorded on the questioner and Case Report Forms transferred to the main study database will be de-identified and patient identification informationname ID number will be replaced by a patient serial number The investigator will complete and sign data forms at the time of hysteroscopy All evaluations are listed in Table 1 All information related to general medical and operative procedural data will be documented and tabulated All information related to complications if any date of occurrence description severity treatment and resolution will be recorded at the time of occurrence
Table 1 Data Collection Table
Group 1 Group 2 Pre-procedure Age Ethnicity Weight Height smoking Medical Gynecological and Surgical History previous hyesteroscopies
Ultrasound findings if available VAS pain score during hysteroscopy Ampule serial number Length of the procedure time at start time at the end Ampule serial number Length of the procedure time at start time at the end
Post-hysteroscopy Procedure related complications Hysteroscopy success and hysteroscopic findings VAS score at the end of the procedure Patient satisfaction 1-10
10 Statistical analysis
Data will be de-identified reviewed and entered onto a spreadsheet and then transferred to a computer statistical package The data will be summarized and comparisons presented according to type of variable Counts will be presented for binary or categorical variables means and standard deviations for dimensional variables and medians and interquartile ranges for those variables involving skewed distributions The two groups will be compared using appropriate types of regression analyses The above analyses allow the two groups to be compared with and without possible confounders such as age weight previous hysteroscopy and smoking status Alpha will be set at 005 95 confidence intervals will be reported wherever appropriate Data will be analyzed using a standard statistical package such as SPSS
101 Calculation of Sample Size
Previous studies 19 have used a sample size of 90 patients to detect a 15 improvement in pain score that seemed of clinical significance and therefore estimated that a sample size of 90 would be able to detect such a difference with a power of 80 and type 1 error α of 005 Therefore a sample size of 100 patients was chosen to allow for 10 attrition providing a net total of 45 per group Patients will be randomized to intervention and control arms at a 11 ratio
11 Ethics
This study protocol will be submitted to Assuta Ashdod University Hospital Ethics committee for approval The study will be conducted in accordance with the ethical principles originating from the Declaration of Helsinki and GCP ICH E6 and in compliance with local regulatory requirements Participants identity will be kept confidential and to the extent permitted by the applicable laws andor regulations will not be made publicly available If the study results are published the participants identity will remain confidential
Informed consent will be obtained in accordance with ICHGCP Guidelines and the Declaration of Helsinki and will be implemented before protocol specific procedures are carried out The risks and benefits of participating in the study will be verbally explained to each potential participant prior to signing the consent form in accordance with local regulatory legal requirements The signed consent form will be retained by the investigator and a copy provided to each participant
12 Source Documentation
The investigator will keep accurate separate records of all participants study data collected including all pertinent study related information The investigators are committed to thorough documentation of all side effects and Adverse Events during the study in a participant study binder including any diagnostic tests conducted during the study
All study documentation will be kept for 15 years after all participants have completed and all data has been collected The IRBIEC will be notified in writing of the study completion and archive site
13 Study Timeline
Patients will be recruited from September 2019 to June 2021 Final data collection and statistical analysis will be performed within 6 months from the completion of the study With G-ods helpDeus Ke ser Publications will be generated by the investigators at the completion of the data analysis
Ambulatory hysteroscopy is a safe feasible and accurate procedure for diagnosing and treating intrauterine pathology 1
Office hysteroscopy does not require hospital admission preparatory tests and general anesthesia Importantly it has decreased postsurgical recovery period global cost of the procedure and rate of complications 2 New approaches have evolved due to technological advances in instrumentation an office hysteroscopy that combines diagnosis and treatment of the pathology into a single clinical procedure is referred to as See and Treat hysteroscopy SATH 3
SATH allows diagnosis of different conditions affecting the uterine cavity in an office setting followed immediately with treatment to resolve them thus avoiding the patient having to undergo a subsequent procedure 4
Pain during or after the procedure can discourage patients from undergoing office diagnostic hysteroscopy or SATH 5 and remains a significant cause for failure to complete the procedure
The type of anesthesia used depends on the procedure the patients level of anxiety and the anesthesiologists expertise Simple diagnostic procedures can be performed without anesthesia with a para-cervical block or with mild sedation In a meta-analysis reviewing 36 studies only para-cervical block demonstrated a significant anesthetic effect Munro There is controversy about anesthesia and analgesia for outpatient hysteroscopy as there is not enough high-quality evidence and marked heterogeneity between trials makes it very difficult to draw generalizable conclusions
In a recent study we have evaluated the effect of distension medium composed of 09 saline solution with Lidocaine vs Saline alone and its effect on pain in diagnostic hysteroscopy No studies had been published regarding this method of analgesia in SATH and its effect on pain during the procedure and immediately following the procedure
2 Aims
The primary aim of the current study is to evaluate the effect of local instillation of lidocaine in relieving pain during office SATH hysteroscopy
Secondary aims include the rate of failure in performing the procedure and patient satisfaction among patients in the study group vs controls
3 Hypothesis
In this prospective randomized double blind study utilizing adult women undergoing office SATH hysteroscopy local instillation of lidocaine in the distension media should reduce the pain during and following the procedure by 20 and also improve patient satisfaction and might reduce failure rates without an increase in complication rates
4 Settings and participants
All patients referred to a diagnostic office SATH hysteroscopy at the outpatient clinics in Assuta Ashdod University Hospital that fit the inclusion criteria
Inclusion criteria
Women between the ages of 20 years - 52 years inclusive
Undergoing SATH office hysteroscopy
Patients are able to provide written consent
Exclusion criteria
Previous Pelvic Inflammatory Disease PID or documented tubal occlusion
Inability to consent due to cognitive or language barrier
Allergy to Lidocaine
Documented failed hysteroscopy prior to the current referral
5 Study methodology and techniques
Study Design
This study is a prospective randomized double blind trial
Women undergoing SATH office hysteroscopy that are eligible for the study will be divided into 2 groups
1 Hysteroscopy using saline alone as a distension medium
2 Hysteroscopy using a 10 ml of 2 lidocaine in a 1000 ml of saline as a distension medium The distension medium bags will be prepared by the Assuta Ashdod University Hospital Pharmacy The first bag will contain 10 ml of 2 lidocaine in a 1000 ml of saline or saline alone and will be coded using a serial number and randomized using computerized software Each patient will be allocated 3 distension media bags THE second an third one will contain saline alone The investigators and patients will be blinded to the composition of the distension medium
A sample size of 100 patients to allow for 10 attrition providing a net total of 45 per groups as described below at a 11 ratio will be included in each group and will complete a questionere prior to and following the procedure Appendix 1 A schematic overview of the research is displayed in figure 1 summarizing the patients participation during each stage of the research Data will be analyzed and the effect of Lidocaine addition to the distension medium will be evaluated
Patients who withdrew from the study will be analyzed as intention to treat patients
6 Recruitment Strategy
Patients will be recruited from the population of patients referred to the outpatient hysteroscopy clinics at Assuta Ashdod University Hospital The investigator will inform the patient about the study its purpose and method of randomization of study groups Patients will not be cajoled into participating in this study The Investigator will discuss foreseeable risks involved as well as potential benefits for each study group Patients who have consented to having their information obtained during the study for analysis of the results will have their confidentiality maintained at all times using a study code as an identifier in the research database The patients will be informed by the Investigator that their medical treatment will not be affected in any mean by their decision whether to participate or not in the study Patients will be informed that they may choose to withdraw from the study at any stage without jeopardizing any further medical care A signed and dated Informed Consent must be obtained by the Investigator from the patient prior to enrolment into this study The original signed and dated information sheet and patient consent will be kept by the Investigator A signed copy will be provided to the patient
7 Data Collection Plan
Demographics age ethnicity
Weight in kg height in cm
Medical gynecological and surgical history
VAS pain score prior to the procedure
Indication for hysteroscopy
Success in performing the procedure Length of the procedure and surgical complications
Hysteroscopic findings
Serial number appearing on the distension medium ampule
VAS score following the procedure
Patient satisfaction score 1-10
Free text regarding the procedure and other patient comments
8 Cost of study
Cost of intervention will be determined by considering the following factors
Cost of pharmaceutical preparation of the distension media and randomization - will be performed by the hospital pharmacy at no cost
Cost of statistical analysis
9 Timing of endpoint measurements
All data recorded on the questioner and Case Report Forms transferred to the main study database will be de-identified and patient identification informationname ID number will be replaced by a patient serial number The investigator will complete and sign data forms at the time of hysteroscopy All evaluations are listed in Table 1 All information related to general medical and operative procedural data will be documented and tabulated All information related to complications if any date of occurrence description severity treatment and resolution will be recorded at the time of occurrence
Table 1 Data Collection Table
Group 1 Group 2 Pre-procedure Age Ethnicity Weight Height smoking Medical Gynecological and Surgical History previous hyesteroscopies
Ultrasound findings if available VAS pain score during hysteroscopy Ampule serial number Length of the procedure time at start time at the end Ampule serial number Length of the procedure time at start time at the end
Post-hysteroscopy Procedure related complications Hysteroscopy success and hysteroscopic findings VAS score at the end of the procedure Patient satisfaction 1-10
10 Statistical analysis
Data will be de-identified reviewed and entered onto a spreadsheet and then transferred to a computer statistical package The data will be summarized and comparisons presented according to type of variable Counts will be presented for binary or categorical variables means and standard deviations for dimensional variables and medians and interquartile ranges for those variables involving skewed distributions The two groups will be compared using appropriate types of regression analyses The above analyses allow the two groups to be compared with and without possible confounders such as age weight previous hysteroscopy and smoking status Alpha will be set at 005 95 confidence intervals will be reported wherever appropriate Data will be analyzed using a standard statistical package such as SPSS
101 Calculation of Sample Size
Previous studies 19 have used a sample size of 90 patients to detect a 15 improvement in pain score that seemed of clinical significance and therefore estimated that a sample size of 90 would be able to detect such a difference with a power of 80 and type 1 error α of 005 Therefore a sample size of 100 patients was chosen to allow for 10 attrition providing a net total of 45 per group Patients will be randomized to intervention and control arms at a 11 ratio
11 Ethics
This study protocol will be submitted to Assuta Ashdod University Hospital Ethics committee for approval The study will be conducted in accordance with the ethical principles originating from the Declaration of Helsinki and GCP ICH E6 and in compliance with local regulatory requirements Participants identity will be kept confidential and to the extent permitted by the applicable laws andor regulations will not be made publicly available If the study results are published the participants identity will remain confidential
Informed consent will be obtained in accordance with ICHGCP Guidelines and the Declaration of Helsinki and will be implemented before protocol specific procedures are carried out The risks and benefits of participating in the study will be verbally explained to each potential participant prior to signing the consent form in accordance with local regulatory legal requirements The signed consent form will be retained by the investigator and a copy provided to each participant
12 Source Documentation
The investigator will keep accurate separate records of all participants study data collected including all pertinent study related information The investigators are committed to thorough documentation of all side effects and Adverse Events during the study in a participant study binder including any diagnostic tests conducted during the study
All study documentation will be kept for 15 years after all participants have completed and all data has been collected The IRBIEC will be notified in writing of the study completion and archive site
13 Study Timeline
Patients will be recruited from September 2019 to June 2021 Final data collection and statistical analysis will be performed within 6 months from the completion of the study With G-ods helpDeus Ke ser Publications will be generated by the investigators at the completion of the data analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None