Pain, PostoperativePhase 4NCT02036827
The Effect of Deep Neuromuscular Blockade on Postoperative Shoulder Tip Pain After Laparoscopic Cholecystectomy
A Phase 4 study testing Rocuronium in people with Pain, Postoperative, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study was to investigate whether there is any difference in incidence of shoulder tip pain after laparoscopic cholecystectomy between the groups with moderate neuromuscular block and deep neuromuscular block. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Rocuronium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2013to Jan 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- physical status by American society of Anesthesiology; 1 or 2 patients
- patients with benign gallbladder disease scheduled for laparoscopic cholecystectomy
Who cannot join
- patient with myasthenia gravis
- allergy to rocuronium or sugammadex
- patient with shoulder pain disease (Ex. rotator cuff tear)
- psychological disease
- patients who cannot understand Korean
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to investigate whether there is any difference in incidence of shoulder tip pain after laparoscopic cholecystectomy between the groups with moderate neuromuscular block and deep neuromuscular block.
Read the detailed description
Laparoscopic cholecystectomy has become the gold standard treatment for gall bladder disease. However, 30-50% of patients suffer from shoulder tip pain, which might arise from diaphragm stretch due to pneumoperitoneum.
In the previous pilot study, working intra-abdominal space was increased in the condition of deep neuromuscular blockade. And thus investigators hypothesized that the depth of neuromuscular blockade can affect insufflation pressure and intra-abdominal volume, which result in the severity of diaphragm stretch and postoperative shoulder pain. In addition, the depth of neuromuscular blockade can alter pulmonary compliance.
- Conditions
- Pain, Postoperative
- Being tested
- Rocuronium
- Keywords
- Pain, Postoperative, Neuromuscular Blocking Agents, Laparoscopy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RocuroniumDrug
Also called Neurpmuscular blockade is provides vy Rocuronium Bromide
We will administrate neuromuscular blocking agent until moderate or deep neuromuscular blockade stabilized.
| Study group | Role | What they receive |
|---|---|---|
| moderate NMB + standard pressure | Active comparator | Investigators will administrate rocuronium until moderate neuromuscular blockade (Train of Four >=1, Post-tetanic count>=8) is established. And pneumoperitoneum will be maintained with standard-pressure 14 mmHg. Receives: Drug: Rocuronium |
| deep NMB + standard pressure | Active comparator | Investigators will administrate rocuronium until deep neuromuscular blockade (Train of Four=0, Post-tetanic count<=3) is established. And pneumoperitoneum will be maintained with standard-pressure 14 mmHg. Receives: Drug: Rocuronium |
| deep NMB + low pressure | Active comparator | Investigators will administrate rocuronium until deep neuromuscular blockade (Train of Four=0, Post-tetanic count<=3) is established. And pneumoperitoneum will be maintained with standard-pressure 8 mmHg. Receives: Drug: Rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder tip pain
The severity of shoulder tip pain will be measured in PACU and upto postoperative 6, 6-12, 12-24 hours.
Measured: upto postoperative 24 hours
Secondary outcomes (6)
Postoperative pain
The severity and the location of postoperative pain will be measured in PACU and upto postoperative 6, 6-12, 12-24 hours after operation.
Measured: upto postoperative 24 hours
Postoperative nausea and vomiting
The severity of nausea, the number of vomiting and the dose and number of administration of rescue antiemetics will be recorded.
Measured: upto postoperative 24hours
Intraoperative hemodynamics
Heart rate and blood pressure will be measured at the completion of anesthetic induction, at the completion of carbon dioxide insufflation, at 15 minutes after carbon dioxide insufflation, at the completion of desufflation of pneumoperitoneum, and at the completion of operation.
Measured: upto postoperative 24hours
pulmonary compliance
Total lung compliance will be measured by the equation : CT (L/cm H2O) = change in volume/ change in pleural pressure It will be measured at the completion of anesthetic induction, at the completion of carbon dioxide insufflation, at 15 minutes after carbon dioxide insufflation, at the completion of desufflation of pneumoperitoneum, and at the completion of operation
Measured: upto postoperative 24 hours
Satisfaction of the surgeon
Satisfaction of the surgeon will be measured by 5-scale numeric rating scale) at the completion of surgery.
Measured: upto postoperative 24 hours
Working intrabdominal space
Working intrabdominal space will be measured by grasper (from skin to sacral promontory) at the completion of carbon dioxide insufflation.
Measured: upto postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yon Hee Shim, Yonsei University
- Investigators
- Yon Hee Shim, MD, PhD, Study director, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036827
- Sponsor's protocol ID
- 3-2013-0210
- Status last verified
- Feb 2015
- First submitted
- 12 Dec 2013
- Last updated
- 9 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Deep Neuromuscular Blockade on Postoperative Shoulder Tip Pain After Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT02036827
- Acronym / sponsor ID
- 3-2013-0210
- Conditions
- Pain, Postoperative
- Keywords
- Pain, Postoperative, Neuromuscular Blocking Agents, Laparoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 15 Jan 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.
The purpose of this study was to investigate whether there is any difference in incidence of shoulder tip pain after laparoscopic cholecystectomy between the groups with moderate neuromuscular block and deep neuromuscular block.
Detailed description
Laparoscopic cholecystectomy has become the gold standard treatment for gall bladder disease. However, 30-50% of patients suffer from shoulder tip pain, which might arise from diaphragm stretch due to pneumoperitoneum.
In the previous pilot study, working intra-abdominal space was increased in the condition of deep neuromuscular blockade. And thus investigators hypothesized that the depth of neuromuscular blockade can affect insufflation pressure and intra-abdominal volume, which result in the severity of diaphragm stretch and postoperative shoulder pain. In addition, the depth of neuromuscular blockade can alter pulmonary compliance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| moderate NMB + standard pressure | Active comparator | Drug: RocuroniumInvestigators will administrate rocuronium until moderate neuromuscular blockade (Train of Four >=1, Post-tetanic count>=8) is established. And pneumoperitoneum will be maintained with standard-pressure 14 mmHg. |
| deep NMB + standard pressure | Active comparator | Drug: RocuroniumInvestigators will administrate rocuronium until deep neuromuscular blockade (Train of Four=0, Post-tetanic count<=3) is established. And pneumoperitoneum will be maintained with standard-pressure 14 mmHg. |
| deep NMB + low pressure | Active comparator | Drug: RocuroniumInvestigators will administrate rocuronium until deep neuromuscular blockade (Train of Four=0, Post-tetanic count<=3) is established. And pneumoperitoneum will be maintained with standard-pressure 8 mmHg. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- physical status by American society of Anesthesiology; 1 or 2 patients
- patients with benign gallbladder disease scheduled for laparoscopic cholecystectomy
Key exclusion criteria (5 listed)
- patient with myasthenia gravis
- allergy to rocuronium or sugammadex
- patient with shoulder pain disease (Ex. rotator cuff tear)
- psychological disease
- patients who cannot understand Korean
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 |
|---|---|---|
| RocuroniumAlso: Neurpmuscular blockade is provides vy Rocuronium BromideWe will administrate neuromuscular blocking agent until moderate or deep neuromuscular blockade stabilized. | Drug | deep NMB + low pressure, deep NMB + standard pressure, moderate NMB + standard pressure |
Primary outcome
Shoulder tip pain
Time frame: upto postoperative 24 hours
The severity of shoulder tip pain will be measured in PACU and upto postoperative 6, 6-12, 12-24 hours.
6 secondary outcomes
Postoperative pain
Time frame: upto postoperative 24 hours
Postoperative nausea and vomiting
Time frame: upto postoperative 24hours
Intraoperative hemodynamics
Time frame: upto postoperative 24hours
pulmonary compliance
Time frame: upto postoperative 24 hours
Satisfaction of the surgeon
Time frame: upto postoperative 24 hours
Working intrabdominal space
Time frame: upto postoperative 24 hours
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 9 Feb 2015.
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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.
Yon Hee Shim, MD, PhD study director
Yonsei 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 Rocuronium in people with Pain, Postoperative, run by Yonsei University 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: finished, as of the sponsor's last update on 9 Feb 2015. 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. 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?
Shoulder tip pain (time frame: upto postoperative 24 hours). 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 Feb 2015.