Pain, PostoperativeNCT03071991
Effect of Preincisional Bupivakain Infiltration on Postoperative Narcotic Medication Requirement
An observational study of Pain, Postoperative, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- study group
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2017to May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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 .
Who may be able to join
- Patients who are eligible for bariatric surgery
Who cannot join
- Refusal for participating to the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Nazif Bagriacik Kadikoy Hospital
Istanbul, Kadikoy, 34718
Abdullah Sisik, M.D., 00905062623325, abdullahsisik@gmail.com
About this study
Official title: Effect of Preincisional Bupivakain Infiltration on Postoperative Narcotic Medication in Laparoscopic Sleeve Gastrectomy
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.
- Conditions
- Pain, Postoperative
- Being tested
- study group, control group
- Keywords
- preinsicional bupivacain, laparoscopic bariatric surgery, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
study groupProcedure or surgery
local anesthetic drug will be used
control groupProcedure or surgery
no local anesthetic drug will be used
| Study group | Role | What they receive |
|---|---|---|
| Study group | Preincisional bupivacain will be used Receives: Procedure: study group | |
| Control group | No preincisional anesthetic drug will be used Receives: Procedure: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
VAS scale will be used
Measured: postoperative 48 hours
postoperative narcotic drug need
VAS scale will be used
Measured: postoperative 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study startJan 2017
- Primary completionApr 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Abdullah Sisik, Umraniye Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03071991
- Sponsor's protocol ID
- PREINS-BUP-POSTOP-NARCOTIC-REQ
- Status last verified
- Mar 2017
- First submitted
- 5 Jan 2017
- Last updated
- 7 Mar 2017
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preincisional Bupivakain Infiltration on Postoperative Narcotic Medication in Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT03071991
- Acronym / sponsor ID
- PREINS-BUP-POSTOP-NARCOTIC-REQ
- Conditions
- Pain, Postoperative
- Keywords
- preinsicional bupivacain, laparoscopic bariatric surgery, postoperative pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Study start
- Jan 2017
- Primary completion
- Apr 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 7 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Procedure: study groupPreincisional bupivacain will be used |
| Control group | – | Procedure: control groupNo preincisional anesthetic drug will be used |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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 .
Key inclusion criteria (1 listed)
- Patients who are eligible for bariatric surgery
Key exclusion criteria (1 listed)
- Refusal for participating to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| study grouplocal anesthetic drug will be used | Procedure or surgery | Study group |
| control groupno local anesthetic drug will be used | Procedure or surgery | Control group |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdullah Sisik, M.D. (00905062623325, abdullahsisik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain (time frame: postoperative 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2017.