NCT04318158

Brief Summary

The aim and objective of this study is to compare dexmedetomidine and fentanyl as adjuvants to bupivacaine in ultrasound guided TAP block analgesia in patients undergoing radical cystectomy as regarding postoperative analgesic efficacy.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Apr 2020

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

March 19, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 23, 2020

Completed
9 days until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

March 23, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

March 19, 2020

Last Update Submit

March 20, 2020

Conditions

Pain

Keywords

DexmedetomidineFentanylBupivacaineTransversus Abdominis Plane Block

Outcome Measures

Primary Outcomes (1)

  • The time for first rescue analgesia after the TAP block.

    Postoperative analgesia duration.

    first 24 hours after block.

Secondary Outcomes (2)

  • the total dose of rescue analgesia after TAP bock.

    first 24 hours after block.

  • VAS for pain.

    0, 2, 4, 6, 12 and 24 hours postoperatively.

Study Arms (3)

Group(B)

EXPERIMENTAL

Patients will receive single shot US guided TAP block using 20 ml bupivacaine 0.25% on each side.

Drug: Bupivacaine

Group(BD)

ACTIVE COMPARATOR

Patients will receive single shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg dexmedetomedine on each side.

Drug: Dexmedetomidine

Group(BF)

ACTIVE COMPARATOR

Patients will receive single shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg fentanyl on each side.

Drug: Fentanyl

Interventions

BupivacaineDRUG

single shot US guided TAP block using 20 ml bupivacaine 0.25%.

Also known as: Sunnypivacaine
Group(B)
DexmedetomidineDRUG

Single shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg dexmedetomedine on each side.

Also known as: Precedex
Group(BD)
FentanylDRUG

Single shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg fentanyl on each side.

Also known as: Fentanyl hameln
Group(BF)

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both sexes.
  • ASA grade I and II.
  • Age between 50-70 years.
  • Elective open radical cystectomy.

You may not qualify if:

  • Any history or signs of cardiac, hepatic and renal failure.
  • Patients with coagulopathy or under anticoagulation therapy.
  • Infection near the site of needle insertion.
  • Morbid obesity (BMI\>40 kg/m2).
  • History of allergic reactions to any of the study medications.
  • Previous abdominal surgery.
  • Patients with any neurological or neuromuscular disorder or history of seizures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Kassim DY, Mahmoud HE, Fakhry DM, Mansour MA. Comparative study of dexmedetomidine versus fentanyl as adjuvants to bupivacaine in ultrasound-guided transversus abdominis plane block in patients undergoing radical cystectomy: a prospective randomised study. BMC Anesthesiol. 2022 Nov 7;22(1):340. doi: 10.1186/s12871-022-01877-1.

    PMID: 36344917DERIVED

MeSH Terms

Conditions

Pain

Interventions

BupivacaineDexmedetomidineFentanyl

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperidines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Management

Study Record Dates

First Submitted

March 19, 2020

First Posted

March 23, 2020

Study Start

April 1, 2020

Primary Completion

April 1, 2021

Study Completion

May 1, 2021

Last Updated

March 23, 2020

Record last verified: 2020-03