Cholecystectomy, LaparoscopicPhase 4NCT02185716
Transversus Abdominis Plane Block (TAP) for Laparoscopic Cholecystectomy Surgery
A Phase 4 study testing Levobupivacaine 0.25 % and Levobupivacaine 0.5% in people with Cholecystectomy, Laparoscopic and Pain, Postoperative, run by Duzce University at 1 site in Turkey (Türkiye).
Trial summary
Postoperative pain is a significant cause of increased morbidity in the perioperative period, leading to patient discomfort and greater hospital length of stay. Laparoscopic cholecystectomy associated with significant postoperative pain, a substantial component of which is derived from abdominal wall incisions. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Cholecystectomy, Laparoscopic, Pain, Postoperative
- What is being tested?
- Levobupivacaine 0.25 % and Levobupivacaine 0.5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2014to Aug 2016
- Phase
- Phase 4
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA I-II risk group,
- between the ages of 20-60,
- undergo elective laporoscopic cholecystectomy operation under general anesthesia
Who cannot join
- allergy to anesthetic medication,
- coronary artery patients,
- obese patients,
- emergencies,
- pregnants,
- abdomen operation history
- heart block
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Of Ultrasound Guided Transversus Abdominis Plane Block (TAP) and Local Infiltration Analgesia During Laparoscopic Cholecystectomy Surgery
Postoperative pain is a significant cause of increased morbidity in the perioperative period, leading to patient discomfort and greater hospital length of stay. Laparoscopic cholecystectomy associated with significant postoperative pain, a substantial component of which is derived from abdominal wall incisions. Ultrasound-guided TAP block increasingly has been used for providing pain relief following abdominal surgery. We designed this study with the hypothesis that, administering TAP block with levobupivacaine in laparoscopic cholecystectomy provides superior analgesic effects than port-side infiltration.
Read the detailed description
In this randomized and double-blind study, 75 patients, American Society of Anesthesiology (ASA) I-II risk group, between the ages of 20-60, who will undergo elective laporoscopic cholecystectomy operation under general anesthesia will be accepted. The patients will be divided into three groups and they will be given postoperative pain treatment with patient-controlled analgesia device. In hours of postoperative 1, 2, 4, 8, 12, 16 and 24, Visual analog scale (VAS) I (superficial pain), VAS II (deep pain), postoperative total analgesic proportion, nausea and vomiting, evaluation postoperative sedation score will be recorded (as conscious:0, asleep:1, deep sleep:2 ) in hours of postoperative 1, 2, 4, 8, 12, 16 and 24.
- Conditions
- Cholecystectomy, Laparoscopic, Pain, Postoperative
- Being tested
- Levobupivacaine 0.25 %, Levobupivacaine 0.5%
- Keywords
- Transversus abdominis plane block, levobupivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levobupivacaine 0.25 %Drug
Also called chirocaine
Levobupivacaine 0.5%Drug
Also called chirocaine
| Study group | Role | What they receive |
|---|---|---|
| local infiltration | Active comparator | Group L (n=25) will be given total 30 ml 0.25 % levobupivacaine infiltration around trocar-site with injector in sterilized conditions without administering TAP block at the end of the operation Receives: Drug: Levobupivacaine 0.5% |
| Control | No intervention | Only routine general anesthesia will be applied |
| TAP | Experimental | Group T (n=25) will be given bilateral total 30 ml 0.25 % levobupivacaine administering TAP block under the guidance of ultrasound at the preoperative period. Receives: Drug: Levobupivacaine 0.25 % |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain scores
VAS I (superficial pain), VAS II (deep pain) recorded in hours of postoperative 1, 2, 4, 8, 12, 16 and 24 h,
Measured: 24 hours
Secondary outcomes (1)
postoperative total analgesic consumption
Measured: Postoperatively 24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startJan 2014
- Primary completionJul 2015
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cholecystectomy, LaparoscopicStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gulbin sezen, Duzce University
- Investigators
- Gülbin Sezen, MD,PhD, Principal investigator, Duzce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185716
- Sponsor's protocol ID
- 2013-414
- Status last verified
- Jul 2020
- First submitted
- 7 Jul 2014
- Last updated
- 22 Jul 2020
- Results posted
- No
Publications
Wassef M, Lee DY, Levine JL, Ross RE, Guend H, Vandepitte C, Hadzic A, Teixeira J. Feasibility and analgesic efficacy of the transversus abdominis plane block after single-port laparoscopy in patients having bariatric surgery. J Pain Res. 2013 Nov 27;6:837-41. doi: 10.2147/JPR.S50561. eCollection 2013.
PubMed 24348067Keir A, Rhodes L, Kayal A, Khan OA. Does a transversus abdominis plane (TAP) local anaesthetic block improve pain control in patients undergoing laparoscopic cholecystectomy? A best evidence topic. Int J Surg. 2013;11(9):792-4. doi: 10.1016/j.ijsu.2013.05.039. Epub 2013 Jun 11.
PubMed 23770342
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Ultrasound Guided Transversus Abdominis Plane Block (TAP) and Local Infiltration Analgesia During Laparoscopic Cholecystectomy Surgery
- ClinicalTrials.gov ID
- NCT02185716
- Acronym / sponsor ID
- 2013-414
- Conditions
- Cholecystectomy, Laparoscopic, Pain, Postoperative
- Keywords
- Transversus abdominis plane block, levobupivacaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 10 Jul 2014 (estimated)
- 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 is a significant cause of increased morbidity in the perioperative period, leading to patient discomfort and greater hospital length of stay. Laparoscopic cholecystectomy associated with significant postoperative pain, a substantial component of which is derived from abdominal wall incisions. Ultrasound-guided TAP block increasingly has been used for providing pain relief following abdominal surgery. We designed this study with the hypothesis that, administering TAP block with levobupivacaine in laparoscopic cholecystectomy provides superior analgesic effects than port-side infiltration.
Detailed description
In this randomized and double-blind study, 75 patients, American Society of Anesthesiology (ASA) I-II risk group, between the ages of 20-60, who will undergo elective laporoscopic cholecystectomy operation under general anesthesia will be accepted. The patients will be divided into three groups and they will be given postoperative pain treatment with patient-controlled analgesia device. In hours of postoperative 1, 2, 4, 8, 12, 16 and 24, Visual analog scale (VAS) I (superficial pain), VAS II (deep pain), postoperative total analgesic proportion, nausea and vomiting, evaluation postoperative sedation score will be recorded (as conscious:0, asleep:1, deep sleep:2 ) in hours of postoperative 1, 2, 4, 8, 12, 16 and 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| local infiltration | Active comparator | Drug: Levobupivacaine 0.5%Group L (n=25) will be given total 30 ml 0.25 % levobupivacaine infiltration around trocar-site with injector in sterilized conditions without administering TAP block at the end of the operation |
| Control | No intervention | –Only routine general anesthesia will be applied |
| TAP | Experimental | Drug: Levobupivacaine 0.25 %Group T (n=25) will be given bilateral total 30 ml 0.25 % levobupivacaine administering TAP block under the guidance of ultrasound at the preoperative period. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA I-II risk group,
- between the ages of 20-60,
- undergo elective laporoscopic cholecystectomy operation under general anesthesia
Key exclusion criteria (7 listed)
- allergy to anesthetic medication,
- coronary artery patients,
- obese patients,
- emergencies,
- pregnants,
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 |
|---|---|---|
| Levobupivacaine 0.25 %Also: chirocaine | Drug | TAP |
| Levobupivacaine 0.5%Also: chirocaine | Drug | local infiltration |
Primary outcome
postoperative pain scores
Time frame: 24 hours
VAS I (superficial pain), VAS II (deep pain) recorded in hours of postoperative 1, 2, 4, 8, 12, 16 and 24 h,
1 secondary outcome
postoperative total analgesic consumption
Time frame: Postoperatively 24 h
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 Jul 2020.
- Results publication: PubMed 24348067Wassef M, Lee DY, Levine JL, Ross RE, Guend H, Vandepitte C, Hadzic A, Teixeira J. Feasibility and analgesic efficacy of the transversus abdominis plane block after single-port laparoscopy in patients having bariatric surgery. J Pain Res. 2013 Nov 27;6:837-41. doi: 10.2147/JPR.S50561. eCollection 2013.
- Results publication: PubMed 23770342Keir A, Rhodes L, Kayal A, Khan OA. Does a transversus abdominis plane (TAP) local anaesthetic block improve pain control in patients undergoing laparoscopic cholecystectomy? A best evidence topic. Int J Surg. 2013;11(9):792-4. doi: 10.1016/j.ijsu.2013.05.039. Epub 2013 Jun 11.
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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.
Gülbin Sezen, MD,PhD principal investigator
Duzce University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levobupivacaine 0.25 % and Levobupivacaine 0.5% in people with Cholecystectomy, Laparoscopic and Pain, Postoperative, run by Duzce 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 7 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 Jul 2020. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
postoperative pain scores (time frame: 24 hours). 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 NCT02185716, which also lists 2 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 Jul 2020.