Postoperative Pain Management, Pain Threshold, Shoulder Pain, LaparoscopiesPhase 4NCT01843010
Effect of Parecoxib on the Change of Shoulder Pain Threshold After Gynecological Laparoscopies
A Phase 4 study testing Parecoxib in people with Postoperative Pain Management, Pain Threshold, Shoulder Pain, Laparoscopies, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
This prospective, double blind, placebo-controlled, parallel group study will be conducted in the first affiliated hospital of Sun yat-sen university in Guangzhou, China. Patients aged 18-65 (ASA I-II) undergoing elective gynecologic laparoscopic surgery with general anesthesia will be involved in this study. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Postoperative Pain Management, Pain Threshold, Shoulder Pain, Laparoscopies
- What is being tested?
- Parecoxib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- May 2013to Nov 2013
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- females age 18-65yr,
- American Society of Anesthesiologists (ASA)I-II,
- Body Mass Index(BMI) 18-25kg/m2.
Who cannot join
- a history of severe cardiac, pulmonary, hepatic, renal disease, chronic drug or alcohol abuse;
- the presence of preoperative shoulder pain or any chronic pain syndrome, long-term use of analgesics; allergy or contraindications to nonsteroidal anti-inflammatory drugs (allergy, peptic ulcer disease, gastroesophageal reflux disease, renal insufficiency, coagulopathy) and any other drugs used in the study;
- patient's pain evaluation is judged unreliable;
- patients with conversion to a laparotomy;
- refuse to coordinate with the follow-up tests.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University.
Guangzhou, Guangdong, 510089
About this study
This prospective, double blind, placebo-controlled, parallel group study will be conducted in the first affiliated hospital of Sun yat-sen university in Guangzhou, China. Patients aged 18-65 (ASA I-II) undergoing elective gynecologic laparoscopic surgery with general anesthesia will be involved in this study. According to previous studies and our pilot trial, estimated 120 patients will be involved in this study. All eligible patients will be randomly assigned to two groups. In group P, patients will receive parecoxib 40mg intravenously 30min before intubation, 8h and 20h after the surgery,respectively. In Group C, patients will receive normal saline at the same time points. The shoulder pressure pain thresholds will be measured with a pressure algometer by an independent doctor blinding to medication and grouping at the day before surgery, 24h and 48h after surgery. Moreover, the intensity of shoulder pain and side effects will be evaluated by another independent doctor at 24h and 48h after surgery. At the end of the observation, the intensity of the maximal shoulder pain will be assessed.
- Being tested
- Parecoxib, Placebo
- Keywords
- NSAIDs, Hyperalgesia, Postlaparoscopic shoulder pain
- Medical subject headings
- Shoulder Pain, Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParecoxibDrug
Parecoxib 40mg will be intravenously infused.
PlaceboDrug
Normal saline 5ml will be intravenously infused.
| Study group | Role | What they receive |
|---|---|---|
| Parecoxib | Active comparator | Intravenously Parecoxib 40mg at 30min before intubation, 8h and 20h after surgery. Receives: Drug: Parecoxib |
| Placebo | Placebo comparator | Normal saline 5ml will be intravenously infused at the same time points., respectively. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of shoulder pressure pain threshold
The patients keep sitting position, and the pressure pain thresholds are measured twice at a fixed point in bilateral levator scapulae, supraspinatus, pectoralis major and flexor carpi ulnaris with a pressure algometer (FPX25, Wagner Instruments, USA) by an independent doctor.
Measured: The pressure pain thresholds are measured at the day before surgery, 24h and 48h after surgery
Secondary outcomes (1)
The severity of shoulder pain
The patients are asked to rate the severity of shoulder pain via a visual analog scale (VAS) ranging from no pain (0) to worst possible pain (10) by another independent doctor.
Measured: At the day before surgery, 24h and 48h after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionNov 2013
- Study completionNov 2013
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 Postoperative Pain Management, Pain Threshold, Shoulder Pain, LaparoscopiesStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuyu Zhang, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Ke xuan Liu, M.D and Ph.D, Study director, 1st affiliated hospital of Sun Yat-sen university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01843010
- Sponsor's protocol ID
- ZSYY-2013-04-23
- Status last verified
- Feb 2014
- First submitted
- 23 Apr 2013
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhang H, Shu H, Yang L, Cao M, Zhang J, Liu K, Xiao L, Zhang X. Multiple-, but not single-, dose of parecoxib reduces shoulder pain after gynecologic laparoscopy. Int J Med Sci. 2012;9(9):757-65. doi: 10.7150/ijms.4916. Epub 2012 Oct 23.
PubMed 23136538
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Parecoxib on the Change of Shoulder Pain Threshold After Gynecological Laparoscopies
- ClinicalTrials.gov ID
- NCT01843010
- Acronym / sponsor ID
- ZSYY-2013-04-23
- Keywords
- NSAIDs, Hyperalgesia, Postlaparoscopic shoulder pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 30 Apr 2013 (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.
This prospective, double blind, placebo-controlled, parallel group study will be conducted in the first affiliated hospital of Sun yat-sen university in Guangzhou, China. Patients aged 18-65 (ASA I-II) undergoing elective gynecologic laparoscopic surgery with general anesthesia will be involved in this study. According to previous studies and our pilot trial, estimated 120 patients will be involved in this study. All eligible patients will be randomly assigned to two groups. In group P, patients will receive parecoxib 40mg intravenously 30min before intubation, 8h and 20h after the surgery,respectively. In Group C, patients will receive normal saline at the same time points. The shoulder pressure pain thresholds will be measured with a pressure algometer by an independent doctor blinding to medication and grouping at the day before surgery, 24h and 48h after surgery. Moreover, the intensity of shoulder pain and side effects will be evaluated by another independent doctor at 24h and 48h after surgery. At the end of the observation, the intensity of the maximal shoulder pain will be assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parecoxib | Active comparator | Drug: ParecoxibIntravenously Parecoxib 40mg at 30min before intubation, 8h and 20h after surgery. |
| Placebo | Placebo comparator | Drug: PlaceboNormal saline 5ml will be intravenously infused at the same time points., respectively. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- females age 18-65yr,
- American Society of Anesthesiologists (ASA)I-II,
- Body Mass Index(BMI) 18-25kg/m2.
Key exclusion criteria (5 listed)
- a history of severe cardiac, pulmonary, hepatic, renal disease, chronic drug or alcohol abuse;
- the presence of preoperative shoulder pain or any chronic pain syndrome, long-term use of analgesics; allergy or contraindications to nonsteroidal anti-inflammatory drugs (allergy, peptic ulcer disease, gastroesophageal reflux disease, renal insufficiency, coagulopathy) and any other drugs used in the study;
- patient's pain evaluation is judged unreliable;
- patients with conversion to a laparotomy;
- refuse to coordinate with the follow-up tests.
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 |
|---|---|---|
| ParecoxibParecoxib 40mg will be intravenously infused. | Drug | Parecoxib |
| PlaceboNormal saline 5ml will be intravenously infused. | Drug | Placebo |
Primary outcome
The change of shoulder pressure pain threshold
Time frame: The pressure pain thresholds are measured at the day before surgery, 24h and 48h after surgery
The patients keep sitting position, and the pressure pain thresholds are measured twice at a fixed point in bilateral levator scapulae, supraspinatus, pectoralis major and flexor carpi ulnaris with a pressure algometer (FPX25, Wagner Instruments, USA) by an independent doctor.
1 secondary outcome
The severity of shoulder pain
Time frame: At the day before surgery, 24h and 48h after 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 19 Feb 2014.
- Background: PubMed 23136538Zhang H, Shu H, Yang L, Cao M, Zhang J, Liu K, Xiao L, Zhang X. Multiple-, but not single-, dose of parecoxib reduces shoulder pain after gynecologic laparoscopy. Int J Med Sci. 2012;9(9):757-65. doi: 10.7150/ijms.4916. Epub 2012 Oct 23.
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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.
Ke xuan Liu, M.D and Ph.D study director
1st affiliated hospital of Sun Yat-sen 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 Parecoxib in people with Postoperative Pain Management, Pain Threshold, Shoulder Pain, Laparoscopies, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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 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 19 Feb 2014. 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 China. 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.
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?
The change of shoulder pressure pain threshold (time frame: The pressure pain thresholds are measured at the day before surgery, 24h and 48h after surgery). 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 NCT01843010, 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 19 Feb 2014.