NCT02826876

Brief Summary

Using local analgesia in laparoscopic surgery in order to reduce pain and to reduce the use of narcotic drugs.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

June 22, 2016

Completed
9 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

July 11, 2016

Status Verified

July 1, 2016

Enrollment Period

1 year

First QC Date

June 22, 2016

Last Update Submit

July 5, 2016

Conditions

Pain

Keywords

Laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

  • Pain scale as measured by pain scale questionnaire

    post operative pain intensity will be assisted by VAS(visual analog pain scale) scale at fixed times after surgery

    1 Week

Secondary Outcomes (1)

  • Reducing use of narcotics according to nurse records

    1 Week

Study Arms (2)

Ropivacaine

PLACEBO COMPARATOR

Topical use of Ropivacaine

Drug: Topical useOther: laparoscopic repair of inguinal herniaOther: laparoscopic bariatric surgery

Placebo

PLACEBO COMPARATOR

Topical use of placebo

Drug: Topical useOther: laparoscopic repair of inguinal herniaOther: laparoscopic bariatric surgery

Interventions

Topical useDRUG

Topical use of Ropivacaine in laparoscopic surgery

Also known as: Ropivacaine, Placebo
PlaceboRopivacaine
laparoscopic repair of inguinal herniaOTHER

intra-operative treatment with ropivacaine Vs placebo in laparoscopic repair of inguinal hernia

PlaceboRopivacaine
laparoscopic bariatric surgeryOTHER

intra-operative treatment with ropivacaine Vs placebo in laparoscopic bariatric surgery

PlaceboRopivacaine

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Laparoscopic bariatric surgery
  • Laparoscopic inguinal hernia surgery

You may not qualify if:

  • Cardiac arrythmias
  • Active ischemic heart disease
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Naharia Medical Center

Nahariya, Israel

Location

MeSH Terms

Conditions

Pain

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Moaad H Farraj, Dr

    Galilee Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Moaad H Farraj, Dr

CONTACT

0507887996moaad.farraj@naharia.health.gov.il

Study Design

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

Study Record Dates

First Submitted

June 22, 2016

First Posted

July 11, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

July 11, 2016

Record last verified: 2016-07

Locations

IL(1)