NCT03394807

Brief Summary

This study investigated the effectiveness of a surgeon administered, laparoscopic guided, regional anaesthesia technique.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2016

Shorter than P25 for phase_4

Status
completed

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

Study Start

First participant enrolled

October 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2017

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 9, 2018

Completed
Last Updated

January 9, 2018

Status Verified

January 1, 2018

Enrollment Period

10 months

First QC Date

December 15, 2017

Last Update Submit

January 8, 2018

Conditions

Regional Anesthesia MorbidityGallbladder StonePain

Outcome Measures

Primary Outcomes (1)

  • Post operative pain score

    Visual analogue pain scores ranging from 0 to 10

    6 hours post operatively

Secondary Outcomes (4)

  • Opioid use

    Perioperative period including first 6 hours post operatively

  • Analgesic use

    Perioperative period including first 6 hours post operatively

  • Readmission rate

    30 days post operative

  • Daycase rates

    Day of surgery

Study Arms (2)

LaGRA

EXPERIMENTAL

regional anaesthesia of the right upper quadrant by injection of levobupivacaine 0.25% to the transversus abdominis plane and the rectus sheath under laparoscopic guidance immediately following specimen removal

Drug: Levobupivacaine

Placebo

PLACEBO COMPARATOR

Sham regional anaesthesia of the right upper quadrant by injection of Saline 0.9% to the transversus abdominis plane and the rectus sheath under laparoscopic guidance immediately following specimen removal

Drug: Placebo

Interventions

LevobupivacaineDRUG

Levobupivacaine injection to Transversus abdominis plane and rectus sheath

Also known as: Chirocaine
LaGRA
PlaceboDRUG

Saline injection to Transversus abdominis plane and rectus sheath

Also known as: Saline
Placebo

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing laparoscopic cholecystectomy
  • ASA I, II or III

You may not qualify if:

  • Patients that don't consent to be included
  • Allergy to levobupivacaine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

CholecystolithiasisPain

Interventions

LevobupivacaineSodium Chloride

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesGallbladder DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, randomised, placebo controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Surgeon

Study Record Dates

First Submitted

December 15, 2017

First Posted

January 9, 2018

Study Start

October 1, 2016

Primary Completion

July 30, 2017

Study Completion

August 30, 2017

Last Updated

January 9, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share