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Laparoscopic CholecystectomyNCT03607266

Effect of Preemptive Ibuprofen and Dexketoprofen in Patients Undergoing Laparoscopic Cholecystectomy

An observational study of Laparoscopic Cholecystectomy, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary aim of this study is to investigate the effects of preventive ibuprofen and dexketoprofen on postoperative opioid requirement in patients undergoing elective laparoscopic cholecystectomy. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Laparoscopic Cholecystectomy
Type of treatment
Injection or infusion
How many people
90 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Aug 2018to 30 Dec 2023
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: patients undergoing laparoscopic cholecystectomy

Who may be able to join

  • Patients scheduled for elective laparoscopic cholecystectomy.
  • Aged 18-65 years
  • ASA score of I and II.

Who cannot join

  • Aged under 18 year Over 65 years Failure to provide a written consent Several cardiac failure, cronic renal failure, Pregnancy, A prior known allergic reaction to the drugs to be administered, Being unable to use patient-controlled analgesia (PCA) pumps, and conversion to open surgery during laparoscopy.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Celaleddin Soyalp

    Van, 65080

Other trials in Turkey (Türkiye)

About this study

Official title: Effect of Preemptive Ibuprofen and Dexketoprofen on Postoperative Opioid Consumption in Patients Undergoing Laparoscopic Cholecystectomy

The primary aim of this study is to investigate the effects of preventive ibuprofen and dexketoprofen on postoperative opioid requirement in patients undergoing elective laparoscopic cholecystectomy. The secondary aim is to compare routine administration of preemptive ibuprofen and dexketoprofen in terms of intraoperative hemodynamic parameters, postoperative complications, and patient satisfaction

Read the detailed description

Study Protocol, Methodology, Procedure: The study will be conducted with 90 patients aged 18-65 years with an ASA score of I and II who are planned for elective laparoscopic cholecystectomy. Patients converted to open surgery during laparoscopy and those with an ASA score of III and IV will be excluded from the study. All the patients will undergo physical examination and laboratory tests 1 day prior to the procedure. On the same day, each patient will be informed about VAS scoring system which is based on a 0-10 scale representing the severity of pain and the patients will be asked to grade their postoperative pain on this scale, where 0 indicates no pain and 10 indicates the most severe pain.

Placebo Group will receive 100 cc of isotonic solution within 30 min before the procedure. Dexketoprofen Group will receive 50 mg iv dexketoprofen in addition to 100 cc of isotonic solution within 30 min before the procedure. Ibuprofen Group will receive 800 mg iv ibuprofen in 100 cc of isotonic solution within 30 min before the procedure. Hemodynamic parameters including heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), and oxygen saturation (SpO2) will be recorded every 10 min for each patient both preoperatively and throughout the procedure. Additionally, total operative time will be recorded for each patient. The surgical procedure will be performed under general anesthesia. Anesthetic induction will be achieved with iv 2 mg/kg propofol, 2 mcg/kg fentanyl, and 0.6 mg/kg rocuronium. Anesthetic maintenance will be achieved with 8% desflurane, 40% O2, and 1 mcg/kg fentanyl. After the surgery, deep and subcutaneous infiltration of trocar insertion sites will be achieved with 4 cc of 0.5% bupivacaine. Moreover, to antagonize the effects of muscle relaxants, intravenous 0.015 mg/kg atropine and 0.04 mg/kg neostigmine will be administered. Patient-controlled analgesia (PCA) will be adjusted to a bolus dose 25 µg of fentanyl with a maximum of 6 doses/h, lockout interval of 10 min, and no basal infusion.

Postoperative Analgesia: Intravenous PCA will be adjusted to a bolus dose 25 µg of fentanyl with a maximum of 6 doses/h, lockout interval of 10 min, and no basal infusion.

Throughout laparoscopy, an intraabdominal pressure of 12-14 mmHg will be maintained. After the procedure, the patients will be transferred to the recovery room. In the recovery room, patients with a modified Aldrete score of 9 or more will be transferred to the general ward. VAS scores at postoperative 1, 2, 4, 6, 12, and 24 h will be recorded as resting VAS scores. The nurses/physicians recording the VAS scores will be blinded to the analgesic drugs and the patient groups. Patients with a VAS score of ≥4 will receive additional 50 mg tramadol in 100 cc of isotonic solution. Total procedure time will be recorded for each patient. Postoperative events occurring within the first 24 h including nausea, vomiting, mouth dryness, itching, palpitation, and headache will be recorded for each patient. At the end of the procedure, a survey will be performed to assess patient satisfaction regarding postoperative pain and other complications. To achieve this, the patients will be asked to grade their satisfaction on a 1 to 3 scale, in which 1 represents poor, 2 represents fair, and 3 represents good outcome.

Keywords
ibuprofen ,, Preemptive analgesia, laparoscopic cholecystectomy, preemptive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03607266
Study groupRoleWhat they receive
Group I (Ibuprofen)Ibuprofen Group will receive 800 mg iv ibuprofen in 100 cc of isotonic solution within 30 min before the procedure
Group D (DexketoprofenDexketoprofen Group will receive 50 mg iv dexketoprofen in addition to 100 cc of isotonic solution within 30 min before the procedure
Placebo Groupwill receive 100 cc of isotonic solution within 30 min before the procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. opioid consumption

    Total opioid consumption as microgram/kg will be assessed in 24 hour surgery

    Measured: First 24 hours total opioid consumption

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2018
  2. Study start20 Aug 2018
  3. Primary completion30 Sep 2022
  4. Study completion30 Dec 2023

Resources

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
Other
Time perspective
Prospective
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03607266
Sponsor's protocol ID
ibupfen
Status last verified
Mar 2024
First submitted
19 Jul 2018
Last updated
26 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Lee IO, Kim SH, Kong MH, Lee MK, Kim NS, Choi YS, Lim SH. Pain after laparoscopic cholecystectomy: the effect and timing of incisional and intraperitoneal bupivacaine. Can J Anaesth. 2001 Jun;48(6):545-50. doi: 10.1007/BF03016830.

    PubMed 11444448

Questions about this trial

What is this clinical trial studying?

An observational study of Laparoscopic Cholecystectomy, run by Yuzuncu Yil University 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 3 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: finished, as of the sponsor's last update on 26 Mar 2024. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

opioid consumption (time frame: First 24 hours total opioid consumption). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03607266, which also lists 1 linked publication.

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 26 Mar 2024.

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