NCT00819962

Brief Summary

Perioperative analgesia using US guided TAP block

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
42

participants targeted

Target at P25-P50 for early_phase_1 postoperative-pain

Timeline
Completed

Started Sep 2014

Longer than P75 for early_phase_1 postoperative-pain

Geographic Reach
1 country

2 active sites

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

January 6, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 9, 2009

Completed
5.6 years until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 15, 2015

Status Verified

November 1, 2014

Enrollment Period

1.2 years

First QC Date

January 6, 2009

Last Update Submit

September 13, 2015

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Pain relief

    after US TAP block

Study Arms (1)

TAP

OTHER

ksu

Drug: BupivacaineOther: TAP

Interventions

BupivacaineDRUG

Local anesthetic

TAP
TAPOTHER
TAP

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • adult undergoing laparoscopic cholecystectomy

You may not qualify if:

  • history of cardiorespiratory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

A Dawlatly

Riyadh, Riyadh Region, Saudi Arabia

RECRUITING

A Dawlatly

Riyadh, Riyadh Region, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

abdelazeem a dawlat, md

CONTACT

4692007dawlatly@ksu.edu.sa

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesia

Study Record Dates

First Submitted

January 6, 2009

First Posted

January 9, 2009

Study Start

September 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

September 15, 2015

Record last verified: 2014-11

Locations

SA(2)