Laparoscopic CholecystectomyNCT01595165
Transversus Abdominis Plane Block and Postoperative Pain After Laparoscopic Cholecystectomy
A study testing Ultrasound guided subcostal TAP block in people with Laparoscopic Cholecystectomy and Postoperative Pain, run by Soonchunhyang University Hospital at 1 site in South Korea.
Trial summary
Transversus abdominis plane (TAP) block has gained popularity for the control of postoperative pain in various surgeries. Three studies showed inconsistent result on pain control after TAP block in laparoscopic cholecystectomy. The TAP technique used in these studies was classic ultrasound guided TAP block. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Laparoscopic Cholecystectomy, Postoperative Pain, Abdominal Muscles
- What is being tested?
- Ultrasound guided subcostal TAP block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2012to Mar 2013
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-II
- Age 20-65 patients scheduled elective laparoscopic cholecystectomy
Who cannot join
- Patient refusal
- Allergy to ropivacaine
- Coagulopathy
- Morbid obesity (BMI>35 kg/m2)
- Previous abdominal surgery.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Sang-Hyun Kim
Bucheon-si, Gyeonggi-do, 420767
Sang-Hyun Kim, M.D., Ph.D., 82-32-621-5328, skim@schmc.ac.kr
About this study
Official title: Effect of Subcostal Transversus Abdominis Plane Block on Early Postoperative Pain in Laparoscopic Cholecystectomy: Randomized, Controlled Trial
Transversus abdominis plane (TAP) block has gained popularity for the control of postoperative pain in various surgeries. Three studies showed inconsistent result on pain control after TAP block in laparoscopic cholecystectomy. The TAP technique used in these studies was classic ultrasound guided TAP block. Besides periumbilical incision, sub-xiphoid incision is usually made during laparoscopic cholecystectomy. As typical posterior TAP rarely extend above T8, the investigators undergo subcostal TAP block for this type of surgery. The investigators are going to investigate the effect of subcostal TAP on early postoperative pain after laparoscopic cholecystectomy.
- Being tested
- Ultrasound guided subcostal TAP block, Placebo Ultrasound guided subcostal TAP block
- Keywords
- laparoscopic cholecystectomy, ultrasound, transversus abdominis plane block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided subcostal TAP blockProcedure or surgery
Under ultrasound guidance0.375% ropivacaine 10 ml will be injected between rectus abdominis and transverse abdominis and same study solution will be injected at subcostal transversus abdominis plane. This block will be done bilaterally.
Placebo Ultrasound guided subcostal TAP blockProcedure or surgery
Under ultrasound guidance saline 10 ml will be injected between rectus abdominis and transverse abdominis and same study solution will be injected at subcostal transversus abdominis plane. This block will be done bilaterally.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Control group receiving saline instead of ropivacaine Receives: Procedure: Placebo Ultrasound guided subcostal TAP block |
| TAP | Experimental | TAP group receiving ropivacaine total of 150 mg at TAP under US Receives: Procedure: Ultrasound guided subcostal TAP block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS) 15 min after entering recovery room
Measured: 15 min after entering recovery room
Secondary outcomes (4)
Fentanyl consumption at recovery room
Measured: Up to 3 hours until discharge from recovery room
Recovery room stay
Measured: Up to 3 hours from entering recovery room to discharge
Incidence of postoperative nausea and vomiting (PONV)
Measured: Up to 3 hours during recovery room stay
NRS at 4h, 24h, and 48 h after surgery
Measured: 4h, 24h, and 48 h after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2012 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soonchunhyang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Sang-Hyun, Soonchunhyang University Hospital
- Investigators
- Sang-Hyun Kim, M.D., Ph.D., Principal investigator, Soonchunhyang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01595165
- Sponsor's protocol ID
- schbcanesthesia
- Status last verified
- Jul 2012
- First submitted
- 7 May 2012
- Last updated
- 9 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Subcostal Transversus Abdominis Plane Block on Early Postoperative Pain in Laparoscopic Cholecystectomy: Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01595165
- Acronym / sponsor ID
- schbcanesthesia
- Keywords
- laparoscopic cholecystectomy, ultrasound, transversus abdominis plane block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Soonchunhyang University HospitalUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 9 May 2012 (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.
Transversus abdominis plane (TAP) block has gained popularity for the control of postoperative pain in various surgeries. Three studies showed inconsistent result on pain control after TAP block in laparoscopic cholecystectomy. The TAP technique used in these studies was classic ultrasound guided TAP block. Besides periumbilical incision, sub-xiphoid incision is usually made during laparoscopic cholecystectomy. As typical posterior TAP rarely extend above T8, the investigators undergo subcostal TAP block for this type of surgery. The investigators are going to investigate the effect of subcostal TAP on early postoperative pain after laparoscopic cholecystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Procedure: Placebo Ultrasound guided subcostal TAP blockControl group receiving saline instead of ropivacaine |
| TAP | Experimental | Procedure: Ultrasound guided subcostal TAP blockTAP group receiving ropivacaine total of 150 mg at TAP under US |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I-II
- Age 20-65 patients scheduled elective laparoscopic cholecystectomy
Key exclusion criteria (5 listed)
- Patient refusal
- Allergy to ropivacaine
- Coagulopathy
- Morbid obesity (BMI>35 kg/m2)
- Previous abdominal surgery.
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 |
|---|---|---|
| Ultrasound guided subcostal TAP blockUnder ultrasound guidance0.375% ropivacaine 10 ml will be injected between rectus abdominis and transverse abdominis and same study solution will be injected at subcostal transversus abdominis plane. This block will be done bilaterally. | Procedure or surgery | TAP |
| Placebo Ultrasound guided subcostal TAP blockUnder ultrasound guidance saline 10 ml will be injected between rectus abdominis and transverse abdominis and same study solution will be injected at subcostal transversus abdominis plane. This block will be done bilaterally. | Procedure or surgery | Control |
Primary outcome
Numerical Rating Scale (NRS) 15 min after entering recovery room
Time frame: 15 min after entering recovery room
4 secondary outcomes
Fentanyl consumption at recovery room
Time frame: Up to 3 hours until discharge from recovery room
Recovery room stay
Time frame: Up to 3 hours from entering recovery room to discharge
Incidence of postoperative nausea and vomiting (PONV)
Time frame: Up to 3 hours during recovery room stay
NRS at 4h, 24h, and 48 h after surgery
Time frame: 4h, 24h, and 48 h after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2012.
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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.
Sang-Hyun Kim, M.D., Ph.D. principal investigator
Soonchunhyang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided subcostal TAP block in people with Laparoscopic Cholecystectomy and Postoperative Pain, run by Soonchunhyang University Hospital at 1 site in South Korea.
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 5 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: status not confirmed, as of the sponsor's last update on 9 Jul 2012. 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 South Korea. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sang-Hyun Kim, M.D., Ph.D. (82-32-621-5328, skim@schmc.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale (NRS) 15 min after entering recovery room (time frame: 15 min after entering recovery room). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2012.