Unique ID issued by UMIN | UMIN000024815 |
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Receipt number | R000028528 |
Scientific Title | Single-blind randomized controlled trial for postoperative analgesic effect of rectus sheath block and infiltrative local anesthesia after laparoscopic cholecystectomy |
Date of disclosure of the study information | 2016/12/01 |
Last modified on | 2021/11/16 13:50:28 |
Single-blind randomized controlled trial for postoperative analgesic effect of rectus sheath block and infiltrative local anesthesia after laparoscopic cholecystectomy
Randmized controlled trial for postoperative analgesic effect after laparoscopic cholecystectomy
Single-blind randomized controlled trial for postoperative analgesic effect of rectus sheath block and infiltrative local anesthesia after laparoscopic cholecystectomy
Randmized controlled trial for postoperative analgesic effect after laparoscopic cholecystectomy
Japan |
gallbladder disease
Hepato-biliary-pancreatic surgery |
Others
NO
The objective of this research is making it clear which anesthesia of a rectus sheath block procedure and the local infiltration anesthesia is superior for postoperative pain after laparoscopic cholecystectomy.
Efficacy
pain evaluation with VAS at the first day after surgery
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Active
2
Treatment
Maneuver |
rectus sheath block group
local infiltration anesthesia group
20 | years-old | <= |
Not applicable |
Male and Female
The patients who have an electively operation of laparoscopic cholecystectomy for the benign gallbladder disease and who agree to this study
none
50
1st name | Naomi |
Middle name | |
Last name | Kitamura |
Shiga University of Medical Science
department of surgery
520-2192
Seta Tsukinowa-cho, Otsu City,Shiga,JAPAN
077-548-2238
naomik@belle.shiga-med.ac.jp
1st name | Naomi |
Middle name | |
Last name | Kitamura |
Shiga University of Medical Science
department of surgery
520-2192
Seta Tsukinowa-cho, Otsu City,Shiga,JAPAN
077-548-2238
naomik@belle.shiga-med.ac.jp
Shiga University of Medical Science
none
Self funding
SUMS Research Ethics Committee
Seta Tsukinowa cho, Otsu city, Shiga Pref.
077-548-3576
hqrec@belle.shiga-med.ac.jp
NO
2016 | Year | 12 | Month | 01 | Day |
https://doi.org/10.1111/ases.12957
Published
https://doi.org/10.1111/ases.12957
62
This study enrolled 62 patients (RSB group=31, LA group=31). On POD1, the mean VAS scores were 36.41+-8.9 and 29.4+-15.4 in the RSB group and LA groups, respectively, showing that the LA group tended to describe lesser postoperative pain than the RSB group (P=0.062).
VAS scores on POD1 were not different between the groups. LC patients might obtain postoperative pain control via long-acting local analgesia.
2021 | Year | 11 | Month | 16 | Day |
2021 | Year | 06 | Month | 22 | Day |
Patients aged > 20 years and scheduled to undergo elective LC for benign gallbladder disease at our hospital were approached for inclusion in the study. Patients were excluded if any the following was applicable: patient refusal, hypersensitivity to local anesthetics, inability to understand the visual analogue scale (VAS) scores for pain due to any reason.
After obtaining informed consent from patients, they were enrolled and assigned to either the RSB group or LA group (1:1, block size 4) using APS-Cloud system. The allocation was done by the minimization method that assumed age and sex as assignment factors. This system was able to randomly separate patients to two groups so that there were no deflections of age and sex. Although the surgeons were not blinded to the treatment group, all the patients were blinded to their group allocation. There were no protocol violations.
No adverse events associated with the nerve block procedure such as neuropathy or LA were reported in any patient.
The primary endpoint of this study was to compare VAS scores of the RSB group with those with the LA group on POD1. Secondary endpoints were VAS scores on POD0, POD2 and POD3, and face scale score, areas under the curve of VAS score, frequency of using analgesic agents, and area of pain on POD0 to POD3.
Completed
2016 | Year | 11 | Month | 07 | Day |
2016 | Year | 11 | Month | 07 | Day |
2016 | Year | 12 | Month | 01 | Day |
2018 | Year | 04 | Month | 30 | Day |
2021 | Year | 06 | Month | 22 | Day |
2021 | Year | 06 | Month | 22 | Day |
2021 | Year | 06 | Month | 22 | Day |
2016 | Year | 11 | Month | 12 | Day |
2021 | Year | 11 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028528
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