Abdominal PainNCT03708874
Pain Management of Emergency Laparoscopic Cholecystectomy in Patients With Acute Cholecystitis
An observational study of Abdominal Pain and Shoulder Pain, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Patients diagnosed with acute cholecystitis benefit from emergency laparoscopic cholecystectomy (LC). Patients who had emergency LC showed improvement in quality of life in one month compared to those treated. Delayed LC (after the acute cholecystitis has passed) and less time to recover from work. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Abdominal Pain, Shoulder Pain, Satisfaction
- Type of treatment
- Injection or infusion
- How many people
- 2 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Oct 2018to 14 Mar 2019
- How long will I take part?
- 6 Months
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient aged 18-70 years diagnosed with ASA I, II and III acute cholecystitis
Who may be able to join
- Acute stone cholecystitis
- Acute acrylic cholecystitis
Who cannot join
- Cholecystitis with chronic stones
- Gallbladder polyps,
- Patients with bleeding diathesis,
- Allergy to local anesthetic agents,
- Patients with paracetamol group allergy,
- Choledocholithiasis associated with acute cholecystitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Intravenous Paracetamol and Intraperitoneal Bupivacaine for Acute Laparoscopic Cholecystectomy Pain Relief in Patients With Acute Cholecystitis. A Prospective Randomized Clinical Trial
Patients diagnosed with acute cholecystitis benefit from emergency laparoscopic cholecystectomy (LC). Patients who had emergency LC showed improvement in quality of life in one month compared to those treated. Delayed LC (after the acute cholecystitis has passed) and less time to recover from work. This strategy reduces the risk of repeated referrals with more pain or pancreatitis. There are many studies on the efficacy of intraoperative intraperitoneal bupivacaine(IPBV) with elective LC on pain of IPBV. However, the prospective study of reducing the postoperative pain of emergency LC - IPBV is very few. This study will be conducted to evaluate the efficacy of IPBV in patients with emergency LC.
Read the detailed description
Patients to be included in the study will be selected from the group between 18 and 70 years of age who apply to general surgery and emergency policlinics, depending on patient approval. All patients will be informed about the operation and the procedures to be performed. Patients who accepted to participate in the study will be included in the study and randomization will be performed by randomly selected patients and two groups. The study will be carried out by 2 surgeons with 5 years of laparoscopic cholecystectomy (LC).Adult patients presenting with acute cholecystitis treated by emergency surgeons by one of two surgeons will be included in the study. These two surgeons will be responsible for the participant records. 1.hepatobiliary ultrasound-confirmed acute cholecystitis diagnosis, 2. Patients undergoing elective laparoscopic cholecystectomy (el-LC) will not be included in the study. Patients converted into an open procedure will be excluded from the study. Patients will be divided into two groups. In Group A, intravenous 1 gr paracetamol via will be applied in 30 minutes after waking up.In Group B, immediately after the introduction of intraoperative laparoscopic trocars, 480 ml of saline + 20 ml of 5% bupivacaine solution will be washed in the subdiaphragmatic area, gallbladder region and the entire abdomen. In both groups, standard laparoscopic cholecystectomy will be performed. In both groups, nasogastric tube will be inserted at the end of the operation after intubation. , CRP(C-reactive protein) levels, ALT(Alanine Aminotransferase) , AST(Aspartate Aminotransferase), GGT(Gamma-Glutamyltransferase), total bilirubin, direct bilirubin values will be recorded. Pulse, heart rate, systolic and diastolic pressures, Oxygen saturation (with pulse) during surgery will be recorded in both groups. Post-operative VAS(Visual analogue score) and VRS(Verbal Rating Scales) pain scores will be performed. VAS 0-10 cm and VRS (no pain in cough (score = 0); pain in cough, not in deep breathing (score = 1); resting (score = 2), pain at rest, mild (score = 3); pain at rest, severe (score = 4)) will be evaluated as.
- Conditions
- Abdominal Pain, Shoulder Pain, Satisfaction, Complication
- Medical subject headings
- Abdominal Pain, Shoulder Pain, Personal Satisfaction
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 1.Intraoperative bupivacaine | intraperitoneal bupivacaine wash-emergency laparoscopic cholecystectomy | |
| Group 2.Intravenous paracetamol | intravenous paracetamol-emergency laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Shoulder Pain
Group 1 and Group 2 Post-operative shoulder pain. VAS score ;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain.
Measured: postoperative 1st day
Secondary outcomes (8)
Post-operative Abdominal Pain 2nd Hour
VAS score ;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain.
Measured: pain at postoperative 2nd hour
operation time
duration of operation(minutes), time from anesthesia induction to extubation of the patient
Measured: up to 100 minutes
Change in C -reactive protein (CRP) level in all study participants
Compare the postoperative 1st day CRP levels with the baseline CRP in study patients. Comparison will be performed using a paired t-test.
Measured: preoperative and postoperative 1st day
Change in alanine aminotransferase (ALT) level in all study participants
Compare the postoperative 1st day ALT levels with the baseline ALT in study patients. Comparison will be performed using a paired t-test.
Measured: preoperative and postoperative 1st day
Change in Aspartate Aminotransferase (AST) level in all study participants
Compare the postoperative 1st day AST levels with the baseline AST in study patients. Comparison will be performed using a paired t-test.
Measured: preoperative and postoperative 1st day
Post-operative Abdominal Pain 6th Hour
VAS score ;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain.
Measured: pain at postoperative 6th hour
Post-operative Abdominal Pain 12th Hour
VAS score ;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain.
Measured: pain at postoperative 12th hour
Post-operative Abdominal Pain 24th Hour
VAS score ;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain.
Measured: pain at postoperative 24th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start9 Oct 2018
- Primary completion9 Jan 2019
- Study completion14 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Abdominal PainStudies 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
- 2 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Turgut Donmez, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Investigators
- Turgut Donmez, surgeon, Principal investigator, Bakirkoy Training and Research HospitalMehmet Emin Gunes, MD, Study director, Bakirkoy Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03708874
- Sponsor's protocol ID
- BakirköyEAH 2
- Status last verified
- Aug 2019
- First submitted
- 9 Oct 2018
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After the patients are included in the study, the patient data will be entered into the system and the results will be evaluated.
Publications
Gurusamy KS, Nagendran M, Toon CD, Guerrini GP, Zinnuroglu M, Davidson BR. Methods of intraperitoneal local anaesthetic instillation for laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2014 Mar 25;2014(3):CD009060. doi: 10.1002/14651858.CD009060.pub2.
PubMed 24668032Kaushal-Deep SM, Anees A, Khan S, Khan MA, Lodhi M. Randomized controlled study of intraincisional infiltration versus intraperitoneal instillation of standardized dose of ropivacaine 0.2% in post-laparoscopic cholecystectomy pain: Do we really need high doses of local anesthetics-time to rethink! Surg Endosc. 2018 Jul;32(7):3321-3341. doi: 10.1007/s00464-018-6053-z. Epub 2018 Jan 16.
PubMed 29340809Roberts KJ, Gilmour J, Pande R, Hodson J, Lam FT, Khan S. Double-blind randomized sham controlled trial of intraperitoneal bupivacaine during emergency laparoscopic cholecystectomy. Hepatobiliary Pancreat Dis Int. 2013 Jun;12(3):310-6. doi: 10.1016/s1499-3872(13)60049-1.
PubMed 23742777
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intravenous Paracetamol and Intraperitoneal Bupivacaine for Acute Laparoscopic Cholecystectomy Pain Relief in Patients With Acute Cholecystitis. A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03708874
- Acronym / sponsor ID
- BakirköyEAH 2
- Conditions
- Abdominal Pain, Shoulder Pain, Satisfaction, Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 9 Oct 2018 (actual)
- Primary completion
- 9 Jan 2019 (actual)
- Study completion
- 14 Mar 2019 (actual)
- First posted
- 17 Oct 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.
Patients diagnosed with acute cholecystitis benefit from emergency laparoscopic cholecystectomy (LC). Patients who had emergency LC showed improvement in quality of life in one month compared to those treated. Delayed LC (after the acute cholecystitis has passed) and less time to recover from work. This strategy reduces the risk of repeated referrals with more pain or pancreatitis. There are many studies on the efficacy of intraoperative intraperitoneal bupivacaine(IPBV) with elective LC on pain of IPBV. However, the prospective study of reducing the postoperative pain of emergency LC - IPBV is very few. This study will be conducted to evaluate the efficacy of IPBV in patients with emergency LC.
Detailed description
Patients to be included in the study will be selected from the group between 18 and 70 years of age who apply to general surgery and emergency policlinics, depending on patient approval. All patients will be informed about the operation and the procedures to be performed. Patients who accepted to participate in the study will be included in the study and randomization will be performed by randomly selected patients and two groups. The study will be carried out by 2 surgeons with 5 years of laparoscopic cholecystectomy (LC).Adult patients presenting with acute cholecystitis treated by emergency surgeons by one of two surgeons will be included in the study. These two surgeons will be responsible for the participant records. 1.hepatobiliary ultrasound-confirmed acute cholecystitis diagnosis, 2. Patients undergoing elective laparoscopic cholecystectomy (el-LC) will not be included in the study. Patients converted into an open procedure will be excluded from the study. Patients will be divided into two groups. In Group A, intravenous 1 gr paracetamol via will be applied in 30 minutes after waking up.In Group B, immediately after the introduction of intraoperative laparoscopic trocars, 480 ml of saline + 20 ml of 5% bupivacaine solution will be washed in the subdiaphragmatic area, gallbladder region and the entire abdomen. In both groups, standard laparoscopic cholecystectomy will be performed. In both groups, nasogastric tube will be inserted at the end of the operation after intubation. , CRP(C-reactive protein) levels, ALT(Alanine Aminotransferase) , AST(Aspartate Aminotransferase), GGT(Gamma-Glutamyltransferase), total bilirubin, direct bilirubin values will be recorded. Pulse, heart rate, systolic and diastolic pressures, Oxygen saturation (with pulse) during surgery will be recorded in both groups. Post-operative VAS(Visual analogue score) and VRS(Verbal Rating Scales) pain scores will be performed. VAS 0-10 cm and VRS (no pain in cough (score = 0); pain in cough, not in deep breathing (score = 1); resting (score = 2), pain at rest, mild (score = 3); pain at rest, severe (score = 4)) will be evaluated as.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1.Intraoperative bupivacaine | – | –intraperitoneal bupivacaine wash-emergency laparoscopic cholecystectomy |
| Group 2.Intravenous paracetamol | – | –intravenous paracetamol-emergency laparoscopic cholecystectomy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient aged 18-70 years diagnosed with ASA I, II and III acute cholecystitis
Key inclusion criteria (2 listed)
- Acute stone cholecystitis
- Acute acrylic cholecystitis
Key exclusion criteria (6 listed)
- Cholecystitis with chronic stones
- Gallbladder polyps,
- Patients with bleeding diathesis,
- Allergy to local anesthetic agents,
- Patients with paracetamol group allergy,
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
Post-operative Shoulder Pain
Time frame: postoperative 1st day
Group 1 and Group 2 Post-operative shoulder pain. VAS score ;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain.
8 secondary outcomes
Post-operative Abdominal Pain 2nd Hour
Time frame: pain at postoperative 2nd hour
operation time
Time frame: up to 100 minutes
Change in C -reactive protein (CRP) level in all study participants
Time frame: preoperative and postoperative 1st day
Change in alanine aminotransferase (ALT) level in all study participants
Time frame: preoperative and postoperative 1st day
Change in Aspartate Aminotransferase (AST) level in all study participants
Time frame: preoperative and postoperative 1st day
Post-operative Abdominal Pain 6th Hour
Time frame: pain at postoperative 6th hour
Post-operative Abdominal Pain 12th Hour
Time frame: pain at postoperative 12th hour
Post-operative Abdominal Pain 24th Hour
Time frame: pain at postoperative 24th hour
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 22 Aug 2019.
- Results publication: PubMed 24668032Gurusamy KS, Nagendran M, Toon CD, Guerrini GP, Zinnuroglu M, Davidson BR. Methods of intraperitoneal local anaesthetic instillation for laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2014 Mar 25;2014(3):CD009060. doi: 10.1002/14651858.CD009060.pub2.
- Results publication: PubMed 29340809Kaushal-Deep SM, Anees A, Khan S, Khan MA, Lodhi M. Randomized controlled study of intraincisional infiltration versus intraperitoneal instillation of standardized dose of ropivacaine 0.2% in post-laparoscopic cholecystectomy pain: Do we really need high doses of local anesthetics-time to rethink! Surg Endosc. 2018 Jul;32(7):3321-3341. doi: 10.1007/s00464-018-6053-z. Epub 2018 Jan 16.
- Results publication: PubMed 23742777Roberts KJ, Gilmour J, Pande R, Hodson J, Lam FT, Khan S. Double-blind randomized sham controlled trial of intraperitoneal bupivacaine during emergency laparoscopic cholecystectomy. Hepatobiliary Pancreat Dis Int. 2013 Jun;12(3):310-6. doi: 10.1016/s1499-3872(13)60049-1.
- Individual participant dataSharing planned: No. After the patients are included in the study, the patient data will be entered into the system and the results will be evaluated.
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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.
Turgut Donmez, surgeon principal investigator
Bakirkoy Training and Research Hospital
Mehmet Emin Gunes, MD study director
Bakirkoy Training and Research Hospital
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 Abdominal Pain and Shoulder Pain, run by Bakirkoy Dr. Sadi Konuk Research and Training 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 2 inclusion and 6 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 22 Aug 2019. 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?
Post-operative Shoulder Pain (time frame: postoperative 1st day). 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 NCT03708874, which also lists 3 linked publications.
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 22 Aug 2019.