NCT02827097

Brief Summary

The primary purpose of this study is to investigate the effect of rectus sheath block on abdominal pain score after robotic single port cholecystectomy. The secondary purpose of this study is to investigate the effect of rectus sheath block on fentanyl consumption during stay of recovery room after surgery.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

Same day

First QC Date

July 4, 2016

Last Update Submit

July 1, 2019

Conditions

Gallbladder Diseases

Outcome Measures

Primary Outcomes (1)

  • Abdominal pain score after surgery

    Change from baseline abdominal pain score up to 24 hours

Secondary Outcomes (1)

  • Fentanyl consumption in recovery room

    Up to 1 hours

Study Arms (2)

Rectus sheath block group

EXPERIMENTAL

1. administration of denogan 2. rectus sheath block with 0.375% ropivacaine

Drug: denogan and rectus sheath block

Control group

PLACEBO COMPARATOR

just administration of denogan

Drug: denogan

Interventions

denogan and rectus sheath blockDRUG

administration of denogan and rectus sheath block with 0.375% ropivacaine

Rectus sheath block group
denoganDRUG

administration of denogan

Control group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • robotic single Port cholecystectomy for gallbladder disease

You may not qualify if:

  • Allergy to ropivacaine, infection, history of abdominal surgery, body mass index more than 30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine

Suwon, Seoum, South Korea

Location

MeSH Terms

Conditions

Gallbladder Diseases

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

July 4, 2016

First Posted

July 11, 2016

Study Start

October 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

July 5, 2019

Record last verified: 2019-07

Locations

KR(1)