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Status unknownNCT03071991Updated Mar 7, 2017

Effect of Preincisional Bupivakain Infiltration on Postoperative Narcotic Medication Requirement

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

The sponsor has not verified this record recently (last verified Mar 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years to 80 Years
Sex
All
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Study 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.

Read the 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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Conditions studied

  • Pain, Postoperative

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Keywords

  • preinsicional bupivacain
  • laparoscopic bariatric surgery
  • postoperative pain
03

In context

Pain, Postoperative

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 →

Lead sponsor

Umraniye Education and Research Hospital is the lead sponsor of 60 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
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 .

Inclusion criteria

  • Patients who are eligible for bariatric surgery

Exclusion criteria

Exclusion Criteria:

  • Refusal for participating to the study
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No

Groups and cohorts

  • Study group

    Preincisional bupivacain will be used

    Procedure: study group

  • Control group

    No preincisional anesthetic drug will be used

    Procedure: control group

Interventions

  • Procedurestudy group

    local anesthetic drug will be used

  • Procedurecontrol group

    no local anesthetic drug will be used

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What researchers measure

Primary outcomes

  1. postoperative pain

    VAS scale will be used

    Time frame: postoperative 48 hours

  2. postoperative narcotic drug need

    VAS scale will be used

    Time frame: postoperative 48 hours

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Study locations

1 of 1 sites recruiting
  • Nazif Bagriacik Kadikoy Hospital
    Istanbul, Kadikoy 34718, Turkey
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03071991
Lead sponsor
Umraniye Education and Research Hospital
Responsible party
Abdullah Sisik (General Surgery Specialist, Umraniye Education and Research Hospital) — Principal investigator
First posted
Mar 7, 2017
Start date
Jan 2017
Primary completion
Apr 2017 (estimated)
Completion
May 2017 (estimated)
Last update
Mar 7, 2017

Study contacts

Abdullah Sisik, M.D.
Contact
abdullahsisik@gmail.com
00905062623325
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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