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).
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.
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.
- Conditions
- Laparoscopic Cholecystectomy
- 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 group | Role | What 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 (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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted31 Jul 2018
- Study start20 Aug 2018
- Primary completion30 Sep 2022
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic CholecystectomyStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Celaleddin Soyalp, Yuzuncu Yil University
- Investigators
- CELALEDDİN SOYALP, Study chair, Yuzuncu Yil University Dursun Odabas Medical School Anesthesiology a nd Reanimation Department, Van, Turkey
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preemptive Ibuprofen and Dexketoprofen on Postoperative Opioid Consumption in Patients Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT03607266
- Acronym / sponsor ID
- ibupfen
- Conditions
- Laparoscopic Cholecystectomy
- Keywords
- ibuprofen ,, Preemptive analgesia, laparoscopic cholecystectomy, preemptive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 31 Jul 2018 (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.
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
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing laparoscopic cholecystectomy
Key inclusion criteria (3 listed)
- Patients scheduled for elective laparoscopic cholecystectomy.
- Aged 18-65 years
- ASA score of I and II.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
opioid consumption
Time frame: First 24 hours total opioid consumption
Total opioid consumption as microgram/kg will be assessed in 24 hour surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Background: PubMed 11444448Lee 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.
- Individual participant dataSharing planned: Undecided
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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.
CELALEDDİN SOYALP study chair
Yuzuncu Yil University Dursun Odabas Medical School Anesthesiology a nd Reanimation Department, Van, Turkey
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 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.