An observational study in Pain, Postoperative, sponsored by Umraniye Education and Research Hospital. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-07.
Sponsored by Umraniye Education and Research Hospital · Observational
Postoperative pain and use of narcotic analgesics after laparoscopic bariatric surgeries are problems that need to be solved in terms of patient comfort. We believe that preincisional bupivacain injection to the trocar sites will help us for these problems. A study is designed focused on reduced postoperative pain and reduced use of narcotic analgesics by preincisional bupivacain injection for laparoscopic bariatric patients.
A randomised controlled prospective study is designed with 40 patients over 2-month period (January 2017 to february 2017). Laparoscopic sleeve gastrectomy is planned for all patients. Two groups are designed depending on whether trocar site infiltration with bupivacaine was performed (study group, 20 patients) or not (control group, 20 patients). The patients with body mass index (BMI) ≥35kg/m2 are enrolled to study. The parameters of demographic characteristics (age, gender, BMI, weight, and body fat percentage), preoperative comorbid conditions (type 2 diabetes mellitus, hypertension), and clinical outcomes (postoperative complications, mortality, readmissions) are planned to record.
Pain evaluation
Visual analogue scale (VAS, 0: no pain, 10: the worst imaginable pain) is planned to be used. VAS measurements timing is planned as follows:
Operative Technique
All patients will be operated by same surgeons and anesthetist. Peroperatively intravenous paracetamol 10 mg, tramadol 50 mg and fentanyl 150 mcg will be used for analgesia. Local infiltration of the port sites was carried out through out all layers with 40 ml 0.25% bupivacaine and 1:200,000 epinephrine before incision. Laparoscopic sleeve gastrectomy will be performed with 5 trocars, in reverse trandelenburg position by creating pneumoperitoneum with 14 mmHg carbon dioxide insufflation. Trocar replacements are one 10-mm trocar in the midline above umbilicus for the endoscope, one 12-mm trocar to right midclavicular line linage to the 10-mm trocar. One 5-mm trocar to the left midclavicular line linage to the 10-mm trocar, one 5-mm trocar to the front axiller line below the left costal margin, and 5-mm trocar 2 cm below the xiphoid process for liver retractor. 38 F orogastric tube will be used. No use of nasogastric tubes and urinary catheters routinely is planned. Drain replacement is planned for all patients.
Postoperative Management
All patients will be mobilised 4th postoperative hour, and all patients will use breathing exercise device hourly. Postoperative analgesia protocol is designed with intravenous paracetamol 1 g every 8 h and deksketoprofen trometamol 50 mg every 12 h, antiemetics (ondansetron 4 mg every 8 h). Narcotic analgesic pethidin hcl 50 mg/ml will be ordered to patients who had > 5 degrees of pain according to VAS. The patients are Oral liquid diet was started on the second postoperative day, advanced to semisolid diet after discharging.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's planned enrollment of 40 is below the median of 102 across 608 observational studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Umraniye Education and Research Hospital is the lead sponsor of 60 studies on the registry; 18 are open to participants now.
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Patients with body mass index (BMI) ≥35kg/m2 will be enrolled to the study. Laparoscopic sleeve gastrectomy will be planned for study patients .
Exclusion Criteria:
Preincisional bupivacain will be used
Procedure: study group
No preincisional anesthetic drug will be used
Procedure: control group
local anesthetic drug will be used
no local anesthetic drug will be used
postoperative pain
VAS scale will be used
Time frame: postoperative 48 hours
postoperative narcotic drug need
VAS scale will be used
Time frame: postoperative 48 hours
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Umraniye Education and Research Hospital