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Clinical trials

Surgical studies to assess banding and IV ibuprofen

One study is recruiting to test the utility of intravenous ibuprofen post-surgery. Photo: Flickr / US Army
Banding study will compare surgery with conventional treatment
Second study will examine pain relief post-surgery

The benefits of gastric banding in adolescents and efficacy intravenous (IV) ibuprofen (Caldorol) for pain relief following laparoscopic surgery, will be assessed in two recently announced clinical trials.

Researchers from the University Hospital of Angers, France, have announced a new study that will compare the effects of the placement of an adjustable gastric band with conventional treatment of obesity, in adolescents aged 12-16.

The “Evaluation of the effects of laying early (between 12 and 16) a gastric band on the prevention of morbid obesity in late adolescence. Randomized checked against standard management of obesity in this population” study, which will begin recruiting patients in 2013, will also record quality of life, body composition and parameters of the metabolic syndrome, and gastric tolerance, between the two groups.

Patients will be recruited during a routine hospital visit when the study will be presented to the patient and their family. They will then be enrolled and randomised to either group A (surgery group) and group B (conventional monitoring dietary, medical and physical). For both groups follow-up visits will occur every three months for two years.

The investigators are hoping to recruit 200 patients to the study, which is planned to be completed by November 2015.

Ibuprofen for bariatric surgery

Researchers from the Jacobi Medical Center, New York, have announced a study that will assess whether IV ibuprofen decreases a patient’s morphine requirement using intravenous patient controlled analgesia in patients after laparoscopic bariatric surgery.

Patients will be randomised into two groups: the experimental group will be given 800mg IV Ibuprofen every six hours starting pre-operatively (up to five doses); and the placebo group will be given IV saline every six hours starting pre-operatively (up to five doses).

The trial will also determine if IV Ibuprofen decreases respiratory depression, improves pain scores at rest and pressure pain thresholds. Tertiary objective is to compare incidence of nausea/vomiting, sedation, itching, blood transfusion, over sedation, urinary retention, GI or surgical

Investigators will recruit 100 patients and is expected to be completed in October 2014.

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