UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047143 |
|---|---|
| Receipt number | R000053779 |
| Scientific Title | Efficacy of cough-trick in reducing pain during spinal anesthesia: a prospective, randomized study |
| Date of disclosure of the study information | 2022/03/10 |
| Last modified on | 2022/03/30 16:59:52 |
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Basic information
Public title
Efficacy of cough-trick in reducing pain during spinal anesthesia: a prospective, randomized study
Acronym
Efficacy of cough-trick in reducing pain during spinal anesthesia: a prospective, randomized study
Scientific Title
Efficacy of cough-trick in reducing pain during spinal anesthesia: a prospective, randomized study
Scientific Title:Acronym
Efficacy of cough-trick in reducing pain during spinal anesthesia: a prospective, randomized study
Region
| Asia(except Japan) | Africa |
Condition
Condition
Pain management
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate the efficacy of the cough-trick compared to local anesthesia infiltration with lidocaine to reduce puncture pain during spinal anesthesia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The pain intensity during spinal anesthesia induction was evaluated using a visual analog scale (VAS).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Two hundred patients (98 male and 102 female) were included in our study. Participants were randomly allocated into two groups. For group A, the skin and subcutaneous tissue were infiltrated with 3 mL of 1% lidocaine without vasoconstrictor, whereas in group B, we asked the patient to repeatedly cough during the insertion of the spinal needle. The pain intensity during spinal anesthesia induction was evaluated using a visual analog scale (VAS).
Interventions/Control_2
Two hundred patients (98 male and 102 female) were included in our study. Participants were randomly allocated into two groups. For group A, the skin and subcutaneous tissue were infiltrated with 3 mL of 1% lidocaine without vasoconstrictor, whereas in group B, we asked the patient to repeatedly cough during the insertion of the spinal needle. The pain intensity during spinal anesthesia induction was evaluated using a visual analog scale (VAS).
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
This study was a prospective, randomized trial carried out on 200 patients of different ages and both sexes who attended Aljadaani Hospital scheduled for elective surgery under spinal anesthesia from February 2019 to May 2021.
Key exclusion criteria
The exclusion criteria were a history of peripheral neuropathy, inability to understand or communicate, anxiety disorders (defined by the Hamilton Anxiety Rating Scale9), failure of the first insertion of the needle, allergy to lidocaine, or patient refusal to participate in the study. Any patients using antidepressants, analgesics, anticonvulsant sedatives, or alcohol were also excluded.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Khaled |
| Middle name | |
| Last name | Saad |
Organization
Assiut University
Division name
Pediatrics
Zip code
71111
Address
Assiut University, Egypt
TEL
+966599760661
ksaad8@yahoo.com
Public contact
Name of contact person
| 1st name | Ahmed |
| Middle name | |
| Last name | Khalifa |
Organization
Assiut university
Division name
Pediatrics
Zip code
71515
Address
Assiut University, Egypt
TEL
+20882368373
Homepage URL
ahmed.khalifa@med.au.edu.eg
Sponsor or person
Institute
Assiut University, Egypt
Institute
Department
Personal name
Funding Source
Organization
Assiut University, Egypt
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Al-Azhar University
Address
Al-Azhar University , Egypt
Tel
+201002467934
d2021egypt@outlook.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 10 | Day |
Related information
URL releasing protocol
We found no significant differences between the groups in pain scores on the VAS.
Publication of results
Unpublished
Result
URL related to results and publications
We found no significant differences between the groups in pain scores on the VAS.
Number of participants that the trial has enrolled
200
Results
We found no significant differences between the groups in pain scores on the VAS.
Results date posted
| 2022 | Year | 03 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Two hundred patients were included in the study for first surgery with spinal anesthesia. We found no significant difference between groups A and B regarding sex, age, and BMI. No significant differences existed (P=0.607) between the two groups in the Hamilton Anxiety Rating Scale before the implication of subcutaneous lidocaine infiltration in group A or using the cough-trick intervention in group B. No significant differences (P=0.772) were found between the groups in VAS scores for evaluating the severity of pain during insertion of the spinal needle
Participant flow
Two hundred patients were included in the study for first surgery with spinal anesthesia. We found no significant difference between groups A and B regarding sex, age, and BMI. No significant differences existed (P=0.607) between the two groups in the Hamilton Anxiety Rating Scale before the implication of subcutaneous lidocaine infiltration in group A or using the cough-trick intervention in group B. No significant differences (P=0.772) were found between the groups in VAS scores for evaluating the severity of pain during insertion of the spinal needle
Adverse events
None
Outcome measures
The pain intensity during spinal anesthesia induction was evaluated using the VAS-1007, ranging from 0 (no pain) to 100 (extreme pain).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2019 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 10 | Day |
Last modified on
| 2022 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053779
