NCT03778671

Brief Summary

The perioperative management of pain following lower abdominal surgery can pose a challenge to anesthesia providers. Conventional practice has involved the use of opioids as well as neuraxial analgesic techniques. Unfortunately, these therapies are not without potential risks and side effects. These include nausea, vomiting, pruritus, urinary retention, constipation, respiratory depression, and sedation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2019

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

First Submitted

Initial submission to the registry

December 16, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

October 18, 2021

Status Verified

October 1, 2021

Enrollment Period

10 months

First QC Date

December 16, 2018

Last Update Submit

October 8, 2021

Conditions

Transversus Abdominis Block

Keywords

transversus abdominis plane blockDexmedetomidineFentanyl

Outcome Measures

Primary Outcomes (1)

  • first analgesic request

    first time to call for analgesia

    24 hours

Study Arms (3)

Group B

EXPERIMENTAL

Patients will receive Levobupivacaine 5%

Drug: Levobupivacaine

Group D

ACTIVE COMPARATOR

Patients will receive Levobupivacaine 5% + 1 µg/kg dexmedetomedine .

Drug: Dexmedetomidine Injection [Precedex]

Group F

ACTIVE COMPARATOR

Patients will receive Levobupivacaine 5% + 1µg/kg fentanyl

Drug: fentanyl

Interventions

LevobupivacaineDRUG

Patients will receive Levobupivacaine 5%

Also known as: Levobupivacaine hydrate
Group B
Dexmedetomidine Injection [Precedex]DRUG

Patients will receive Levobupivacaine 5% + 1 µg/kg dexmedetomedine

Group D
fentanylDRUG

Patients will receive Levobupivacaine 5% + 1 µg/kg fentanyl

Group F

Eligibility Criteria

Age65 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • ASA physical status II-III,
  • scheduled for uncomplicated elective paraumbilical hernia repair.

You may not qualify if:

  • Patient refusal to participate in the study
  • Patients with coagulopathy or under anticoagulation therapy.
  • Infection near the site of needle insertion.
  • Body mass index \> 40kg/m2
  • Patients with any neurological or neuromuscular disorder or history of seizures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut governorate

Asyut, Egypt

Location

Related Publications (5)

  • Elvir-Lazo OL, White PF. The role of multimodal analgesia in pain management after ambulatory surgery. Curr Opin Anaesthesiol. 2010 Dec;23(6):697-703. doi: 10.1097/ACO.0b013e32833fad0a.

    PMID: 20847690BACKGROUND

  • White PF, Kehlet H. Improving postoperative pain management: what are the unresolved issues? Anesthesiology. 2010 Jan;112(1):220-5. doi: 10.1097/ALN.0b013e3181c6316e. No abstract available.

    PMID: 20010418BACKGROUND

  • Sharma P, Chand T, Saxena A, Bansal R, Mittal A, Shrivastava U. Evaluation of postoperative analgesic efficacy of transversus abdominis plane block after abdominal surgery: A comparative study. J Nat Sci Biol Med. 2013 Jan;4(1):177-80. doi: 10.4103/0976-9668.107286.

    PMID: 23633858BACKGROUND

  • McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f.

    PMID: 17179269BACKGROUND

  • Aditianingsih D, Mochtar CA, Chandra S, Sukmono RB, Soamole IW. Comparison of Three-Quadrant Transversus Abdominis Plane Block and Continuous Epidural Block for Postoperative Analgesia After Transperitoneal Laparoscopic Nephrectomy. Anesth Pain Med. 2018 Sep 3;8(5):e80024. doi: 10.5812/aapm.80024. eCollection 2018 Oct.

    PMID: 30533391BACKGROUND

MeSH Terms

Interventions

LevobupivacaineDexmedetomidineFentanyl

Intervention Hierarchy (Ancestors)

BupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperidines

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

December 16, 2018

First Posted

December 19, 2018

Study Start

January 1, 2019

Primary Completion

November 1, 2019

Study Completion

December 1, 2019

Last Updated

October 18, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)