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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
Sponsor:
Information provided by (Responsible Party):
Abdullah Sisik, Umraniye Education and Research Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Pain, Postoperative Procedure: study group Procedure: control group

Detailed Description:

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:

  • first postoperative day: 4th, 8th, 12th, and 24th hours
  • second postoperative day: 48th hour.

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.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
Study group
Preincisional bupivacain will be used
Procedure: study group
local anesthetic drug will be used

Control group
No preincisional anesthetic drug will be used
Procedure: control group
no local anesthetic drug will be used




Primary Outcome Measures :
  1. postoperative pain [ Time Frame: postoperative 48 hours ]
    VAS scale will be used

  2. postoperative narcotic drug need [ Time Frame: postoperative 48 hours ]
    VAS scale will be used



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with body mass index (BMI) ≥35kg/m2 will be enrolled to the study. Laparoscopic sleeve gastrectomy will be planned for study patients .
Criteria

Inclusion Criteria:

  • Patients who are eligible for bariatric surgery

Exclusion Criteria:

  • Refusal for participating to the study

Information from the National Library of Medicine

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


Contacts
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Contact: Abdullah Sisik, M.D. 00905062623325 abdullahsisik@gmail.com

Locations
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Turkey
Nazif Bagriacik Kadikoy Hospital Recruiting
Istanbul, Kadikoy, Turkey, 34718
Contact: Abdullah Sisik, M.D.    00905062623325    abdullahsisik@gmail.com   
Sponsors and Collaborators
Umraniye Education and Research Hospital
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Responsible Party: Abdullah Sisik, General Surgery Specialist, Umraniye Education and Research Hospital
ClinicalTrials.gov Identifier: NCT03071991    
Other Study ID Numbers: PREINS-BUP-POSTOP-NARCOTIC-REQ
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Abdullah Sisik, Umraniye Education and Research Hospital:
preinsicional bupivacain
laparoscopic bariatric surgery
postoperative pain
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations