Quadratus Lumborum Block for Postoperative Analgesia After Colostomy Closure

Ultrasound-guided Quadratus Lumborum Block for Postoperative Analgesia After Colostomy: A Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: normal saline; Drug: levo-bupivacaine

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Placebo QL block; 30 ml single shot QL block with saline 0.9%	Drug: normal saline
Active Comparator: Active QL block; 30 ml single shot QL block with 0.25% levo-bupivacaine	Drug: levo-bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
cumulative morphine consumption	1 hour

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: February 17, 2016
• First Submitted That Met QC Criteria: February 21, 2016
• First Posted (Estimate): February 25, 2016

Study Record Updates

• Last Update Posted (Estimate): February 25, 2016
• Last Update Submitted That Met QC Criteria: February 21, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine; Levobupivacaine
• Other Study ID Numbers: QLCO