Routine Irrigation With Ropivacaine vs. Lidocaine vs. Saline of Surgical Bed in Sleeve Gastrectomy
Information source: The Baruch Padeh Medical Center, Poriya
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Overweight and Obesity
Intervention: control saline (Drug); Lidocaine (Drug); Ropivacaine (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: The Baruch Padeh Medical Center, Poriya Official(s) and/or principal investigator(s):
Hagar Mizrahi, M.D. MSc, Principal Investigator, Affiliation: The BARUCH PADEH Medical Center, Poriya, ISRAEL
Overall contact:
Nissim Geron, MD, Phone: 972-4-6652667, Email: ngeron@poria.health.gov.il
Summary
The aim of this study is to evaluate the effect of ropivacaine and lidocaine irrigation at
the surgical bed on postoperative pain relief and breathing parameters in laparoscopic
sleeve gastrectomy.
Clinical Details
Official title: Routine Irrigation With Ropivacaine vs. Lidocaine vs. Saline of Surgical Bed in Sleeve Gastrectomy
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Primary outcome: The aim of the study is to evaluate the effect of local irrigation with ropivacaine vs. Lidocaine vs. Saline of surgical bed in sleeve gastrectomy on post operative pain
Detailed description:
As in any other surgery, postoperative pain control after bariatric procedure should provide
comfort and early mobilisation as well as enable adequate respiratory effort.
Early ambulation is thought to reduce the risk of pressure ulcers, deep vein thrombosis and
respiratory complications. In contrast, early inadequate postoperative pain management can
lead to hypoxemia, hypercarbia and atelectasis. However, the use of opioids for pain control
is limited in bariatric surgery due to sedative effect which might worsen obstructive sleep
apnoea (OSA), a common comorbidity amongst morbidly obese patients and opioid-sparing
techniques might help avoid respiratory complications.
Methods of regional analgesic are limited and might be challenging in the obese patient and
although techniques such continuous epidural analgesia is possible it is not the common
practise. The use of patient-controlled i. v. analgesia of opioids is limited owed to
increased risk for hypoxemia and other practises such as routine local anaesthetic port site
wound infiltration and systemic non-steroidal drugs are warranted.
The benefit of intra-peritoneal irrigation with local anaesthetic for abdominal pain relief
after laparoscopic procedures was established in few studies. The aim of this study is to
evaluate the effect its' effect on postoperative pain relief and breathing parameters in
laparoscopic sleeve gastrectomy. By pain score
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patient admitted to sleeve gastrectomy
Exclusion Criteria:
- Second bariatric procedure Patients younger than 18 years Patients who have drug
allergy to Lidocaine or Ropivacain Patients who suffer a cardiac arrhythmia Pregnant
patients Mentally challenged patients Patients who refuse to participate in the study
Locations and Contacts
Nissim Geron, MD, Phone: 972-4-6652667, Email: ngeron@poria.health.gov.il
General Surgery Ward, Poriya, The Lower Galilee, Israel; Not yet recruiting
Hagar Mizrahi, MD MSc, Phone: 972-4-6652667, Email: hmizrahi@poria.health.il
Hagar Mizrahi, MD MSc, Principal Investigator
Additional Information
Starting date: January 2014
Last updated: December 27, 2013
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