NCT02691403

Brief Summary

Patients undergoing abdominal procedures often require multimodal postoperative pain controls. Truncal blocks such as quadratus lumborum (QL) block may be used adjunctively as a part of it. The investigators hypothesized that the ultrasound-guided QL block with transmuscular approach can provide adequate pain relief for colostomy closure as part of a multimodal pain control.

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at below P25 for phase_4 postoperative-pain

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 25, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Last Updated

February 25, 2016

Status Verified

February 1, 2016

Enrollment Period

1.3 years

First QC Date

February 17, 2016

Last Update Submit

February 21, 2016

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • cumulative morphine consumption

    1 hour

Study Arms (2)

Placebo QL block

SHAM COMPARATOR

30 ml single shot QL block with saline 0.9%

Drug: normal saline

Active QL block

ACTIVE COMPARATOR

30 ml single shot QL block with 0.25% levo-bupivacaine

Drug: levo-bupivacaine

Interventions

levo-bupivacaineDRUG
Active QL block
normal salineDRUG
Placebo QL block

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A physical status between ASA I and III
  • years of age
  • Patient has signed an informed consent
  • Without contraindication of QL block

You may not qualify if:

  • American Society of Anesthesiologists (ASA) Physical Status ≥ 4
  • Any contraindication to nerve blocks (including coagulopathy, abnormal anatomy, infection at the planned QL injection site, and amide-type local anesthetic allergy) pregnancy or breast-feeding
  • Severe obesity (body mass index≥ 35 kg/m2)
  • Patients with a history of significant neurological, psychiatric, neuromuscular, cardiovascular, pulmonary, renal or hepatic disease
  • Allergy to NSAIDs
  • Infection at the QL injection site
  • Patients with major psychosis or drug and alcohol abuse
  • Patient unable to comprehend or use the verbal rating pain scoring system or patient-controlled analgesia pump

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

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

Study Record Dates

First Submitted

February 17, 2016

First Posted

February 25, 2016

Study Start

March 1, 2016

Primary Completion

June 1, 2017

Last Updated

February 25, 2016

Record last verified: 2016-02