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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02691403
Other study ID # QLCO
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received February 17, 2016
Last updated February 21, 2016
Start date March 2016

Study information

Verified date February 2016
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority Taiwan: Ministry of Health and Welfare
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 75 Years
Eligibility Inclusion Criteria:

- A physical status between ASA I and III

- 20 - 75 years of age

- Patient has signed an informed consent

- Without contraindication of QL block

Exclusion Criteria

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
levo-bupivacaine

normal saline


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Outcome

Type Measure Description Time frame Safety issue
Primary cumulative morphine consumption 1 hour No
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