Pain Relieving Efficacy of TAP Block in Patients After Laparoscopic Gastric Bypass.
|ClinicalTrials.gov Identifier: NCT01308554|
Recruitment Status : Completed
First Posted : March 4, 2011
Last Update Posted : March 26, 2014
|Condition or disease||Intervention/treatment||Phase|
|Pain Obesity Surgery Neuromuscular Inhibition||Drug: Placebo: sterile normal saline Drug: Marcaine||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||Analgesic Efficacy of Ultrasound-guided Single Shot Subcostal Transversus Abdominis Plane (TAP) Block After Laparoscopic Gastric Bypass.|
|Study Start Date :||February 2011|
|Primary Completion Date :||February 2013|
|Study Completion Date :||February 2013|
Placebo Comparator: Sterile normal saline
Control group will receive sterile normal saline in the block
Drug: Placebo: sterile normal saline
Bilateral TAP block using 20 ml of normal sterile saline per block.
Active Comparator: Marcaine
Study group will receive a bilateral TAP block using 20 ml of Marcaine 2,5 mg/ml on each side.
Study group will receive a bilateral TAP block using 20 ml of 0,25% Marcain on each side.
Other Name: Bupivacaine
- 24h morphine consumption [ Time Frame: 24h after the block is given ]
- Post operative nausea score [ Time Frame: Before surgery and every second hour after surgery until nighttime and again three measurements each day for two weeks. ]none = 0; mild = 1; moderate = 2; severe = 3
- Measurement of lung function (FEV1 and FVC) [ Time Frame: Before surgery and 24h after. ]
- The Verbal Analogue Scale (VAS) scores at rest and on moving [ Time Frame: Before surgery and every second hour after surgery until nighttime and again three measurements each day for two weeks. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01308554
|Privathospitalet Hamlet Aarhus|
|Aarhus N, Denmark, 8200|
|Principal Investigator:||Peter Funch-Jensen, D.M.Sc.||Privathospital Hamlet Aarhus, Denmark|