NCT02064530

Brief Summary

the aim of this study is evaluate postoperative analgesic effects of dexmedetomidine added to bupivacaine on TAP block in patients undergoing lower abdominal surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for phase_4 pain

Timeline
Completed

Started Feb 2014

Typical duration for phase_4 pain

Geographic Reach
1 country

1 active site

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

February 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 17, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 14, 2015

Status Verified

September 1, 2015

Enrollment Period

1.6 years

First QC Date

February 14, 2014

Last Update Submit

September 11, 2015

Conditions

Pain

Keywords

TAP blockdexmedetomidinebupivacainepostoperative analgesia

Outcome Measures

Primary Outcomes (1)

  • opioid consumption

    patient controlled analgesia

    postoperative 1 day

Secondary Outcomes (1)

  • visual analog scale

    postoperative 1 day

Study Arms (3)

bupivacaine

ACTIVE COMPARATOR

0,5% 20 ml bupivacaine added 0.9% 1 ml serum physiologic on TAP block

Drug: Bupivacaine

dexmedetomidine

ACTIVE COMPARATOR

100 mcg dexmedetomidine added to 0,5% 20 ml bupivacaine on TAP block

Drug: Dexmedetomidine

serum phsyologic

SHAM COMPARATOR

0,9% 21 ml serum physiologic

Drug: serum physiologic

Interventions

BupivacaineDRUG

21 ml 0.5 %bupivacaine is applied interfasially

Also known as: marcaine
bupivacaine
DexmedetomidineDRUG

1 ml dexmedetomidin + 20 ml 0.5 % bupivacaine are applied interfasially

Also known as: precedex
dexmedetomidine
serum physiologicDRUG

21 ml serum physiologic is applied interfasially

serum phsyologic

Eligibility Criteria

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

You may qualify if:

  • ASA 1-2
  • aged
  • patient undergoing lower abdominal surgery

You may not qualify if:

  • chronic opioid consumption
  • bupivacaine and dexmedetomidine allergies
  • coagulopathy
  • infection at the needle insertion side
  • chronic liver and kidney disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes universty

Kayseri, Melikgazi, 38039, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

BupivacaineDexmedetomidine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Recep Aksu, assoc. prof.

    Erciyes universty medicine faculty

    STUDY DIRECTOR

  • Gülçin Patmano, resident

    Erciyes universty medicine faculty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associated prof.

Study Record Dates

First Submitted

February 14, 2014

First Posted

February 17, 2014

Study Start

February 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

September 14, 2015

Record last verified: 2015-09

Locations

TU(1)