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Spinal morphine and bupivacaine for postoperative analgesia following robot-assisted laparoscopic prostatectomy : a prospective randomized controlled study

Status Approved

First Submitted Date

2019/10/09
Registered Date

2019/10/17
Last Updated Date

2020/01/14

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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	KCT0004350
Unique Protocol ID	KC19MESI0629
Public/Brief Title	Analgesic efficacy of intrathecal morphine and bupivacaine during the early postoperative period in patients who underwent robotic-assisted laparoscopic prostatectomy
Scientific Title	Spinal morphine and bupivacaine for postoperative analgesia following robot-assisted laparoscopic prostatectomy : a prospective randomized controlled study
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	KC19MESI0629
Approval Date	2019-10-07
Institutional Review Board Name	CMC Clinical Reseach Coordinating Center
Institutional Review Board Address	222, Banpo-daero, Seocho-gu, Seoul
Institutional Review Board Telephone	02-2258-8202
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	Minsuk Chae
Title	Doctor
Telephone	+82-2-2258-6150
Affiliation	The Catholic University of Korea, Seoul St. Mary's Hospital
Address	222, Banpo-daero, Seocho-gu, Seoul
Contact Person for Public Queries
Name	Jung-Woo Shim
Title	Doctor
Telephone	+82-2-2258-6150
Affiliation	The Catholic University of Korea, Seoul St. Mary's Hospital
Address	222, Banpo-daero, Seocho-gu, Seoul
Contact Person for Updating Information
Name	Jung-Woo Shim
Title	Doctor
Telephone	+82-2-2258-6150
Affiliation	The Catholic University of Korea, Seoul St. Mary's Hospital
Address	222, Banpo-daero, Seocho-gu, Seoul

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	Recruiting
Date of First Enrollment	2019-10-09 Actual
Target Number of Participant	50
Primary Completion Date	2020-09-01 , Anticipated
Study Completion Date	2020-09-08 , Anticipated
Name of Study	The Catholic University of Korea, Seoul St. Mary's Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2019-10-09 ,

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	The Catholic University of Korea, Seoul St. Mary's Hospital
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	The Catholic University of Korea, Seoul St. Mary's Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Prostate cancer surgery has been increasing in the aging trend. Especially, robot-assisted laparoscopic prostatectomy (RALP) has a merit in that it can see the surgical image in three dimensions. Moreover, the incisional length of RALP is rather short and the postoperative pain is thought to be minimal. However, RALP is reported to cause comparable postoperative pain during the immediate postoperative period, compared to open prostatectomy. Intrathecal morphine administration has been widely used in abdominal, urologic and obstetric surgeries for postoperative analgesia. However its onset time is 30 minutes to 1 hour and it takes several hours to reach maximal analgesic effect. So it may not provide enough analgesic effect in immediate postoperative period. On the other hand, intrathecal bupivacaine has been used for acute pain management as well as regional anesthesia. Spinal bupivacine has rapid onset and its peak effect time takes only 5-10 minutes. Therefore, the co-administration of intrathecal morphine and bupivacaine may be very effective in acute postoperative pain management. The purpose of this study is to evaluate its postoperative analgesia in patients undergoing RALP.

Study Summary Information

Lay Summary

Prostate cancer surgery has been increasing in the aging trend. Especially, robot-assisted laparoscopic prostatectomy (RALP) has a merit in that it can see the surgical image in three dimensions. Moreover, the incisional length of RALP is rather short and the postoperative pain is thought to be minimal. However, RALP is reported to cause comparable postoperative pain during the immediate postoperative period, compared to open prostatectomy.
Intrathecal morphine administration has been widely used in abdominal, urologic and obstetric surgeries for postoperative analgesia. However its onset time is 30 minutes to 1 hour and it takes several hours to reach maximal analgesic effect. So it may not provide enough analgesic effect in immediate postoperative period.
On the other hand, intrathecal bupivacaine has been used for acute pain management as well as regional anesthesia. Spinal bupivacine has rapid onset and its peak effect time takes only 5-10 minutes. Therefore, the co-administration of intrathecal morphine and bupivacaine may be very effective in acute postoperative pain management. The purpose of this study is to evaluate its postoperative analgesia in patients undergoing RALP.

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	Supportive Care
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Open
Allocation	RCT
Intervention Type	Drug
Intervention Description	In the experimental group, general anesthesia was performed after a single administration of intrathecal morphine 7.5 mcg and bupivaaine 7.5mg. In the control group, general anesthesia was performed without spinal administration. In both groups, intravenous patient controlled analgesia is used for postoperative period.
Number of Arms	2
Arm 1	Arm Label Intrathecal morphine and bupivacaine group
	Target Number of Participant 25
	Arm Type Experimental
	Arm Description General anesthesia was performed after a single administration of intrathecal morphine 7.5 mcg and bupivaaine 7.5mg. And intravenous patient controlled analgesia is used for postoperative period.
Arm 2	Arm Label IV PCA only group
	Target Number of Participant 25
	Arm Type No intervention
	Arm Description General anesthesia was performed without spinal administration. And intravenous patient controlled analgesia is used for postoperative period.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (C00-D48)Neoplasms (C61)Malignant neoplasm of prostate Prostatic Neoplasms
Rare Disease	No
Inclusion Criteria	Gender Male
	Age 19Year~75Year
	Description 1. Robotic-assisted laparoscopic prostate cancer surgery at Seoul St. Mary's Hospital 2. Adults (age more than 19 years old and lesser than 75 years old) 3. American Society of Anesthesiologists grade 1 or 2
Exclusion Criteria	1. Disagreement to participate in this study 2. Emergency surgery 3. Children (under 19 years old) 4. Old (over the 75 years old) 5. American Society of Anesthesiologists grade 3, 4 or 5 6. Massive hemorrhage to require blood transfusion during surgery 7. Severe hemodynamic instability to require continuous vasopressor infusion during surgery 8. Moderate to severe postoperative nausea and vomiting causing to stop additional narcotic analgesics within 24 hours after surgery
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	Efficacy
Outcome	total opioid consumption (morphine milligram equivalents) in the first 24 hours
Timepoint	24 hours after the operation
Secondary Outcome(s) 1
Outcome	The evaluation of pain at 1 hour, 6 hour, and 24 hour after surgery (Numeric Rating Scale)
Timepoint	at 1 hour, 6 hour, and 24 hour after surgery
Secondary Outcome(s) 2
Outcome	Complications occurs for 24 hours after surgery
Timepoint	24 hours after the operation

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	No

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	Not provided at time of Registration

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