UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047494 |
|---|---|
| Receipt number | R000053939 |
| Scientific Title | Preoperative versus Postoperative Rectus Sheath Block for Acute Postoperative Pain Relief - A Retrospective cohort study |
| Date of disclosure of the study information | 2022/04/16 |
| Last modified on | 2024/04/16 10:59:57 |
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Basic information
Public title
Preoperative versus Postoperative Rectus Sheath Block for Acute Postoperative Pain Relief - A Retrospective cohort study
Acronym
Preoperative versus Postoperative Rectus Sheath Block for Acute Postoperative Pain Relief - A Retrospective cohort study
Scientific Title
Preoperative versus Postoperative Rectus Sheath Block for Acute Postoperative Pain Relief - A Retrospective cohort study
Scientific Title:Acronym
Preoperative versus Postoperative Rectus Sheath Block for Acute Postoperative Pain Relief - A Retrospective cohort study
Region
| Japan |
Condition
Condition
Patients undergoing laparoscopic surgery in surgery, urology, and gynecology
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In recent years, ultrasound-guided nerve blocks for intraoperative/postoperative analgesia have become widely used. The rectus sheath block (RSB) is effective in reducing the systemic pain in the midsection of the anterior abdominal wall and has recently been used in abdominal surgery, including laparoscopic surgery and umbilical hernia surgery. Currently, there is no consensus on whether the block should be applied preoperatively or postoperatively in abdominal surgery, and the decision is left up to the anesthesiologist performing the procedure at our hospital. In the present study, we sought to determine whether the timing of block administration in abdominal surgery influences postoperative analgesic efficacy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Administration of analgesics within 24 hours after completion of anesthesia (time of extubation)
Key secondary outcomes
Time from surgery completion date to discharge (days)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We included adult (18years older) surgical, urological, and gynecological patients who underwent laparoscopic surgery at our institution between January 1, 2013 and December 31, 2018.
Key exclusion criteria
We excluded patients as follows: patients with epidural anesthesia; with spinal subarachnoid anesthesia; with intransvenous patient-controlled analgesia (iv-PCA); with conversion to laparotomy; who were received postoperative ventilator; who were received both preoperative and postoperative RSB
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Toko |
| Middle name | |
| Last name | Fukushima |
Organization
The Jikei University Katsushika Medical Center
Division name
Department of Anesthesiology
Zip code
125-8506
Address
6-41-2 Aoto, Katsushika-ku, Tokyo 125-8506, JAPAN
TEL
03-3603-2111
j.toko.fukushima105@gmail.com
Public contact
Name of contact person
| 1st name | Toko |
| Middle name | |
| Last name | Fukushima |
Organization
The Jikei University Katsushika Medical Center
Division name
Department of Anesthesiology
Zip code
125-8506
Address
6-41-2 Aoto, Katsushika-ku, Tokyo 125-8506, JAPAN
TEL
03-3603-2111
Homepage URL
j.toko.fukushima105@gmail.com
Sponsor or person
Institute
The Jikei University Katsushika Medical Center
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
The Jikei University Katsushika Medical Center
Address
6-41-2 Aoto, Katsushika-ku, Tokyo 125-8506, JAPAN
Tel
03-3603-2111
j.toko.fukushima105@gmail.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 | 04 | Month | 16 | Day |
Related information
URL releasing protocol
https://journals.lww.com/md-journal/fulltext/2024/03290/preoperative_versus_postoperative.59.aspx
Publication of results
Published
Result
URL related to results and publications
https://journals.lww.com/md-journal/fulltext/2024/03290/preoperative_versus_postoperative.59.aspx
Number of participants that the trial has enrolled
609
Results
In total, 609/14,284 patients were included (pre-RSB group, 227 patients; post-RSB group, 382 patients). After PS matching, 97 patients were assigned to both groups. Although the time from extubation to the first analgesic request was not significantly different between the 2 groups (322 vs 294 minutes, P = .57), the patients in the pre-RSB group showed a lower risk of postoperative first analgesic administration after PS matching (adjusted hazard ratio, 0.71; 95% confidence interval, 0.53-0.95; P = .023).
Results date posted
| 2024 | Year | 04 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We included adult (18 years old and older) patients with surgical, urological, and gynecological issues who underwent laparoscopic surgery at our institution between January 1, 2013, and December 31, 2018.
Participant flow
From January 1, 2013, to December 31, 2018, 2396 of 14,284 patients underwent laparoscopic surgery, and 628 patients met the inclusion criteria. After excluding 11 patients who had undergone both pre- and post-RSB, 231 and 386 patients were allocated to the pre-RSB and post-RSB groups, respectively. Eight patients were excluded because they received epidural anesthesia or iv-PCA or had undergone conversion to laparotomy. Finally, 227 and 382 patients were included in the pre- and post-RSB groups, respectively. A total of 51 data points were missing for 3 variables (BMI, predictive operative time, and operative time). Consequently, we performed 1:1 PS matching with a caliper of 0.2 and a C-statistic of 0.902, and patients were assigned to the 2 groups (pre-RSB [n = 97] and post-RSB [n = 97])
Adverse events
none
Outcome measures
The primary outcome was the time to rescue analgesia within 24 hours postanesthesia.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 01 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
This study, a historical cohort study, examined the effect of RSB (preoperative RSB group) versus postoperative RSB (postoperative RSB group) on postoperative analgesia in preoperative surgical, urological, and gynecological patients who underwent laparoscopic surgery at our institution between January 1, 2013 and December 31, 2018.
Management information
Registered date
| 2022 | Year | 04 | Month | 15 | Day |
Last modified on
| 2024 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053939
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/01/12 | plan-RSB202301.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2023/01/12 | Data Set Specifications.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2023/01/12 | RSB_dataset.xlsx |
