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CompletedNCT03607266Updated Mar 26, 2024

Effect of Preemptive Ibuprofen and Dexketoprofen in Patients Undergoing Laparoscopic Cholecystectomy

An observational study in Laparoscopic Cholecystectomy, sponsored by Yuzuncu Yıl University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-03-26.

Sponsored by Yuzuncu Yıl University · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
90
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Laparoscopic Cholecystectomy

Keywords

  • ibuprofen ,
  • Preemptive analgesia
  • laparoscopic cholecystectomy
  • preemptive
03

In context

Lead sponsor

Yuzuncu Yıl University is the lead sponsor of 124 studies on the registry; 7 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients undergoing laparoscopic cholecystectomy

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
90 participants (actual)
Patient registry
No

Groups and cohorts

  • 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 (Dexketoprofen

    Dexketoprofen Group will receive 50 mg iv dexketoprofen in addition to 100 cc of isotonic solution within 30 min before the procedure

  • Placebo Group

    will receive 100 cc of isotonic solution within 30 min before the procedure

06

What researchers measure

Primary outcomes

  1. opioid consumption

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

    Time frame: First 24 hours total opioid consumption

07

Study locations

1 site
  • Celaleddin Soyalp
    VAN, 65080, Turkey
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03607266
Lead sponsor
Yuzuncu Yıl University
Responsible party
Celaleddin Soyalp (Assist. prof., Yuzuncu Yıl University) — Principal investigator
First posted
Jul 31, 2018
Start date
Aug 20, 2018
Primary completion
Sep 30, 2022
Completion
Dec 30, 2023
Last update
Mar 26, 2024

Study contacts

CELALEDDİN SOYALP
study chair · Yuzuncu Yil University Dursun Odabas Medical School Anesthesiology a nd Reanimation Department, Van, Turkey

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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