Effect of Preincisional Bupivakain Infiltration on Postoperative Narcotic Medication Requirement
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|ClinicalTrials.gov Identifier: NCT03071991|
Recruitment Status : Unknown
Verified March 2017 by Abdullah Sisik, Umraniye Education and Research Hospital.
Recruitment status was: Recruiting
First Posted : March 7, 2017
Last Update Posted : March 7, 2017
|Condition or disease||Intervention/treatment|
|Pain, Postoperative||Procedure: study group Procedure: control group|
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.
Visual analogue scale (VAS, 0: no pain, 10: the worst imaginable pain) is planned to be used. VAS measurements timing is planned as follows:
- first postoperative day: 4th, 8th, 12th, and 24th hours
- second postoperative day: 48th hour.
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.
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.
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Effect of Preincisional Bupivakain Infiltration on Postoperative Narcotic Medication in Laparoscopic Sleeve Gastrectomy|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||April 2017|
|Estimated Study Completion Date :||May 2017|
Preincisional bupivacain will be used
Procedure: study group
local anesthetic drug will be used
No preincisional anesthetic drug will be used
Procedure: control group
no local anesthetic drug will be used
- postoperative pain [ Time Frame: postoperative 48 hours ]VAS scale will be used
- postoperative narcotic drug need [ Time Frame: postoperative 48 hours ]VAS scale will be used
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03071991
|Contact: Abdullah Sisik, M.D.||email@example.com|
|Nazif Bagriacik Kadikoy Hospital||Recruiting|
|Istanbul, Kadikoy, Turkey, 34718|
|Contact: Abdullah Sisik, M.D. 00905062623325 firstname.lastname@example.org|