UMIN-CTR Clinical Trial

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
Email	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
Email	ahmed.khalifa@med.au.edu.eg

Sponsor
Institute	Assiut University, Egypt
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053779