Effect of Preincisional Bupivakain Infiltration on Postoperative Narcotic Medication Requirement

NCT ID: NCT03071991

Last Updated: 2017-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pain, Postoperative

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study group

Preincisional bupivacain will be used

study group

Intervention Type PROCEDURE

local anesthetic drug will be used

Control group

No preincisional anesthetic drug will be used

control group

Intervention Type PROCEDURE

no local anesthetic drug will be used

Interventions

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study group

local anesthetic drug will be used

Intervention Type PROCEDURE

control group

no local anesthetic drug will be used

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients who are eligible for bariatric surgery

Exclusion Criteria

* Refusal for participating to the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Umraniye Education and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Abdullah Sisik

General Surgery Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nazif Bagriacik Kadikoy Hospital

Istanbul, Kadikoy, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Abdullah Sisik, M.D.

Role: CONTACT

00905062623325

Facility Contacts

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Abdullah Sisik, M.D.

Role: primary

00905062623325

Other Identifiers

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PREINS-BUP-POSTOP-NARCOTIC-REQ

Identifier Type: -

Identifier Source: org_study_id

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