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Register:	ClinicalTrials.gov
Last refreshed on:	8 January 2018
Main ID:	NCT02949778
Date of registration:	25/10/2016
Prospective Registration:	Yes
Primary sponsor:	Vestre Viken Hospital Trust
Public title:	Quadratus Lumborum Block for Abdominoplasty
Scientific title:	Quadratus Lumborum Block for Perioperative Analgesia in Patients Treated With Abdominoplasty: A Randomised Controlled Trial
Date of first enrolment:	November 7, 2016
Target sample size:	50
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02949778
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
Phase:	Phase 4

Countries of recruitment
Norway

Contacts

Name:	Thor Wilhelm Bjelland, MD, PhD
Address:
Telephone:
Email:
Affiliation:	Vestre Viken HT, Baerum Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- American Society of Anesthesiologists Physical Classification Status (ASA) I-II

- Age 18 to 64

- Weight above or equal to 60 kg

- Scheduled for post-bariatric surgery with standard full abdominoplasty performed by Dr
Frøyen

- Patient is expected able to cooperate during the treatment and follow up.

- Signed informed consent obtained and documented according to the International
Conference on Harmonization (ICH) good clinical practice (GCP), and national/local
regulations.

Exclusion Criteria:

- A history of anaphylactic shock

- Cardiovascular disease other than hypertension and/or hyperlipidemia

- Known allergy to ropivacaine or morphine

- A history of chronic pain

- Psychiatric comorbidity

- Scheduled opioid pain medication or neuroleptic drugs

- Coagulation disorders or treatment with platelet inhibitors

- Pregnancy or breastfeeding

- Treatment with class III antiarrhythmics, sertindole, ziprasidone, amisulpride,
ceritinib, hydroxyzine, fluvoxamine

- Any medical contraindication to the study intervention by the attending anaesthetist
or surgeon (to be specified in screening form).

Age minimum: 18 Years
Age maximum: 64 Years
Gender: All

Health Condition(s) or Problem(s) studied

Abdominoplasty

Pain, Postoperative

Intervention(s)

Drug: Sodium Chloride

Procedure: QL-block

Drug: Ropivacaine

Primary Outcome(s)

Opioid consumption [Time Frame: 24 hours]

Secondary Outcome(s)

Secondary ID(s)

BS-AIO-2015-QL-block

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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