NCT02031510

Brief Summary

The use of dexmedetomidine as an adjunct to bupivacaine in transversus abdominis plane block will reduce the cumulative morphine consumption after laparoscopic cholecystectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
195

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

2 active sites

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

January 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

April 6, 2015

Status Verified

April 1, 2015

Enrollment Period

1.1 years

First QC Date

January 7, 2014

Last Update Submit

April 3, 2015

Conditions

Elective Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (1)

  • postoperative 24-hours cumulative morphine consumption

    the retrieved postoperative 24-hours cumulative morphine consumption from the PCA pump report

    for 24 hours after surgery

Secondary Outcomes (5)

  • cumulative use of fentanyl

    for 2 hours during surgery

  • postoperative pain at rest

    for 24 hours after surgery

  • postoperative pain on movement

    for 24 hours aftersurgery

  • sedation scores

    For 24 hours after surgery

  • Time to bowel recovery

    for 24 hours after surgery

Study Arms (3)

bupivacaine-dexmedetomidine

ACTIVE COMPARATOR

transversus abdominis plane block with bupivacaine 0.25% with dexmedetomidine 1 µg Kg-1

Drug: bupivacaine-dexmedetomidine

bupivacaine

ACTIVE COMPARATOR

transversus abdominis plane block with bupivacaine 0.25%

Drug: bupivacaine

placebo

PLACEBO COMPARATOR

Transversus abdominis block with saline 0.9%

Drug: placebo

Interventions

placeboDRUG

transversus abdominis plane block with saline 0.9%

placebo
bupivacaineDRUG

transversus abdominis plane block bupivacaine 0.25%

bupivacaine
bupivacaine-dexmedetomidineDRUG

transversus abdominis plane block with bupivacaine 0.25% with dexmedetomidine 1 µg Kg-1

bupivacaine-dexmedetomidine

Eligibility Criteria

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

You may qualify if:

  • American Society of Anesthesiologists class I and II patients
  • general anaesthesia

You may not qualify if:

  • cardiovascular disease
  • respiratory disease
  • neurological disease
  • renal disease
  • hepatic disease
  • hormonal disease
  • pregnancy
  • body mass index \> 35 kg/m2)
  • smokers
  • alcohol abuse
  • use of antipsychotics
  • communication barriers
  • local anesthetics allergy
  • chronic use of opioids
  • use of nonsteroidal anti-inflammatory drug use during the 24 hours immediately preceding surgery
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

King Fahd Hospital of Dammam University

Khobar, Eastern Province, 31592, Saudi Arabia

Location

Dammam University

Khobar, Eastern Province, 31952, Saudi Arabia

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Abdulmohsen A Al Ghamdi, MD

    Chairman of Anesthesiology Dept

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2014

First Posted

January 9, 2014

Study Start

January 1, 2014

Primary Completion

February 1, 2015

Study Completion

March 1, 2015

Last Updated

April 6, 2015

Record last verified: 2015-04

Locations

SA(2)