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The effect of Ultrasound-guided Phrenic Nerve Block on Shoulder Pain after a Laparoscopic Cholecystectomy

Status Approved

First Submitted Date

2015/06/26
Registered Date

2015/07/01
Last Updated Date

2017/10/15

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0001551
Unique Protocol ID	C2011159(609)
Public/Brief Title	Effect of Phrenic Nerve Block on Shoulder Pain after a Laparoscopic Cholecystectomy
Scientific Title	The effect of Ultrasound-guided Phrenic Nerve Block on Shoulder Pain after a Laparoscopic Cholecystectomy
Acronym	LCPHNB
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	C2011159(609)
Approval Date	2011-10-06
Institutional Review Board Name	Institutional Review Board of Chung Ang University Hospital
Institutional Review Board Address
Institutional Review Board Telephone
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Hwa Yong Shin
Title	M.D., Ph.D., FIPP
Telephone	+82-2-6299-2577
Affiliation	Chung-Ang Univerisity Hospital
Address	102 Heukseok-ro, Dongjak-gu, Seoul, South Korea, 06973
Contact Person for Public Queries
Name	Hwa Yong Shin
Title	M.D., Ph.D., FIPP
Telephone	+82-2-6299-2577
Affiliation	Chung-Ang Univerisity Hospital
Address	102 Heukseok-ro, Dongjak-gu, Seoul, South Korea, 06973
Contact Person for Updating Information
Name	Hwa Yong Shin
Title	M.D., Ph.D., FIPP
Telephone	+82-2-6299-2577
Affiliation	Chung-Ang Univerisity Hospital
Address	102 Heukseok-ro, Dongjak-gu, Seoul, South Korea, 06973

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Completed
Date of First Enrollment	2015-08-03 Actual
Target Number of Participant	64
Primary Completion Date	2016-08-31 , Actual
Study Completion Date	2016-12-31 , Actual
Name of Study	Chung-Ang Univerisity Hospital
Recruitment Status	Completed
Date of First Enrollment	2015-08-03 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Chung-Ang Univerisity Hospital
Organization Type	Medical Institute
Project ID	C2011159(609)

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Chung-Ang Univerisity Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	In this study, we want to know the etiology of post-laparoscopic shoulder pain (PLSP) and the effect of ultrasound-guided phrenic nerve block on the prevention of PLSP. Patients are randomized into two groups; control group and phnb group (group of patients who receive ultrasound-guided phrenic nerve block). Ultrasound evaluation of right diaphragmatic excursion and pulmonary function test (FEV1, FVC , PEF) with spirometry will be performed in all patients of both groups prior to the inducion of general anesthesia. After GA induction,patient's head will be rotated to the left with supine position. After prescanning at C5-6 level which is 2.5 cm above from the right scapula with high frquency linear probe, the needle will be introduced from 1 cm lateral to the probe with short-axis and in-plane technique. Then, right phrenic nerve block will be performed with 4 ml of 0.75% ropivacaine. At the recovery of GA, block sucess will be confirmed by right diaphragmatic palsy with ultrasound. After recovery evaulation of diaphragmatic excursion with ultrasound and pulmonary function test, patients will be discharge from the postanesthetic care unit. The existence, location and severity (VAS, Visual Analogue Scale) of PLSP, parietal pain and visceral pain will be evaulated at post recovery 1 hr, 4 hr, 12 hr, 24 hr and 48 hr.

Study Summary Information

Lay Summary

In this study, we want to know the etiology of post-laparoscopic shoulder pain (PLSP) and the effect of ultrasound-guided phrenic nerve block on the prevention of PLSP. Patients are randomized into two groups; control group and phnb group (group of patients who receive ultrasound-guided phrenic nerve block). Ultrasound evaluation of right diaphragmatic excursion and pulmonary function test (FEV1, FVC , PEF) with spirometry will be performed in all patients of both groups prior to the inducion of general anesthesia. After GA induction,patient's head will be rotated to the left with supine position. After prescanning at C5-6 level which is 2.5 cm above from the right scapula with high frquency linear probe, the needle will be introduced from 1 cm lateral to the probe with short-axis and in-plane technique. Then, right phrenic nerve block will be performed with 4 ml of 0.75% ropivacaine.
At the recovery of GA, block sucess will be confirmed by right diaphragmatic palsy with ultrasound. After recovery evaulation of diaphragmatic excursion with ultrasound and pulmonary function test, patients will be discharge from the postanesthetic care unit. The existence, location and severity (VAS, Visual Analogue Scale) of PLSP, parietal pain and visceral pain will be evaulated at post recovery 1 hr, 4 hr, 12 hr, 24 hr and 48 hr.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Prevention
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Double
Blinded Subject	Subject, Investigator
Allocation	RCT
Intervention Type	/Procedure/Surgery
Intervention Description	Patients are randomized into two groups; control group and phnb group (group of patients who receive ultrasound-guided phrenic nerve block). In PhNB group, after GA induction,patient's head will be rotated to the left with supine position. After prescanning at C5-6 level which is 2.5 cm above from the right scapula with high frquency linear probe, the needle will be introduced from 1 cm lateral to the probe with short-axis and in-plane technique. Then, right phrenic nerve block will be performed with 4 ml of 0.75% ropivacaine. In control group, the phrenic nerve block will not be performed
Number of Arms	2
Arm 1	Arm Label Control group
	Target Number of Participant 32
	Arm Type No intervention
	Arm Description In control group, the phrenic nerve block will not be performed
Arm 2	Arm Label ultrasound-guided phrenic nerve block group (group PhNB)
	Target Number of Participant 32
	Arm Type Experimental
	Arm Description In PhNB group, after GA induction,patient's head will be rotated to the left with supine position. After prescanning at C5-6 level which is 2.5 cm above from the right scapula with high frquency linear probe, the needle will be introduced from 1 cm lateral to the probe with short-axis and in-plane technique. Then, right phrenic nerve block will be performed with 4 ml of 0.75% ropivacaine.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (K00-K93)Diseases of the digestive system (K82.9)Disease of gallbladder, unspecified
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 20Year~70Year
	Description Patients scheduled for elective laparoscopic cholecystectomy under general anesthesia, aged 20–70 years, and having American Society of Anesthesiologists physical status ≤ 3 will be included.
Exclusion Criteria	Exclusion criteria are aged <20 and >70 yrs old, body weight ≤ 45 kg and ≥ 100 kg, American Society of Anesthesiologists physical status > 3, refusal to participate, psychotic disorders, pregnancy, coagulopathy, allergy to local anesthetics, neuromuscular disorders, cardiopulmonary disorders and long term use of analgesics.
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	/Safety/Efficacy
Outcome	Postlaparoscopic shoulder pain
Timepoint	Preprocedure, Postprocedure 1hr, Postprocedure 4hr, Postprocedure 12hr, Postprocedure 24hr, Postprocedure 48hr
Secondary Outcome(s) 1
Outcome	surgical wound incisional pain
Timepoint	Preprocedure, Postprocedure 1hr, Postprocedure 4hr, Postprocedure 12hr, Postprocedure 24hr, Postprocedure 48hr
Secondary Outcome(s) 2
Outcome	visceral pain
Timepoint	Preprocedure, Postprocedure 1hr, Postprocedure 4hr, Postprocedure 12hr, Postprocedure 24hr, Postprocedure 48hr
Secondary Outcome(s) 3
Outcome	Modified Borg Scale
Timepoint	Preprocedure, Postprocedure 1hr, Postprocedure 4hr, Postprocedure 12hr, Postprocedure 24hr, Postprocedure 48hr
Secondary Outcome(s) 4
Outcome	Diaphragmatic Excursion
Timepoint	Preprocedure, Postprocedure 1hr, Postprocedure 24hr
Secondary Outcome(s) 5
Outcome	Pulmonary Function Test
Timepoint	Preprocedure, Postprocedure 1hr, Postprocedure 24hr
Secondary Outcome(s) 6
Outcome	Supplemental analgesic requirements
Timepoint	Postprocedure 1hr, Postprocedure 4hr, Postprocedure 12hr, Postprocedure 24hr, Postprocedure 48hr
Secondary Outcome(s) 7
Outcome	Side effect (nause, vomitting, dizziness, hoarness, Horner syndrome etc)
Timepoint	Postprocedure 1hr, Postprocedure 4hr, Postprocedure 12hr, Postprocedure 24hr, Postprocedure 48hr

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	Yes
Final Enrollment Number
Number of Publication	1
Publications 1	Myung Sub Yi, Won Joong Kim, Min Kyoung Kim, Hyun Kang, Yong-Hee Park, Yong Hun Jung, Seung Eun Lee, Hwa Yong Shin. Effect of ultrasound-guided phrenic nerve block on shoulder pain after laparoscopic cholecystectomy-a prospective, randomized controlled trial.. Surgical endoscopy. SCI. 2017-09-01 , VOL : 31 page : 3637 ~ 3645 https://link.springer.com/article/10.1007%2Fs00464-016-5398-4
Results Upload
Date of Posting Results	2015/07/01
Protocol URL or File Upload
Brief Summary

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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