Postoperative Pain ScorePhase 4NCT03259243
Comparison of Efficacy of Bupivacaine for Relief Postoperative Pain in Women Undergoing Laparoscopic Gynecologic Surgery
A Phase 4 study testing Bupivacaine Hydrochloride in people with Postoperative Pain Score, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial summary
To comparison of efficacy of Bupivacaine for relief postoperative pain in women undergoing laparoscopic gynecologic surgery Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain Score
- What is being tested?
- Bupivacaine Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- 1 Apr 2017to 31 Jan 2018
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patient who undergoing gynecologic laparoscopic surgery
- Patient who agrees to participate in this study
- Patient able to speak and understand Thai
- Patient able to complete the questionnaire
Who cannot join
- Patient with history of allergy in any kind anesthetic drug
- Patient who pregnant
- Patient who sign for single port gynecologic laparoscopic surgery or NOTE surgery
- Patient whom the surgery is withhold or canceled
- Patient whom the surgery is converted to laparotomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Port Site Infiltration With Bupivacaine for Reduction of Postoperative Pain in Woman Undergoing Gynecologic Laparoscopy: A Randomized, Factorial, Double-Blind, Controlled Trial
To comparison of efficacy of Bupivacaine for relief postoperative pain in women undergoing laparoscopic gynecologic surgery
Read the detailed description
Gynecologic laparoscopic procedures have become more common nowadays because of their benefits in less tissue trauma, less perioperative morbidity and shorter hospital stays compared with laparotomy. But postoperative pain still be the most concerning problems including discomfort at incision sites, Pain due to pneumoperitoneum stretching the intraabdominal cavity and dissection of the abdominal and pelvic viscera.
Visceral pain is at maximal intensity during the first postoperative hours and is exacerbated by coughing, respiratory movements, and mobilization. Because the pain comprises of several factors, multimodal analgesic techniques are needed for effective postoperative analgesia and brought to this study to compare efficacy of Bupivacaine for pain relief postoperatively in women undergoing gynecologic laparoscopic surgery divided into 4 groups including preincision and preclosure Bupivacaine injection collated with placebo group. The result is measurement in postoperative pain score and amount of drug that using to reduce pain
- Conditions
- Postoperative Pain Score
- Being tested
- Bupivacaine Hydrochloride
- Keywords
- Bupivacaine, Port site infiltration ,Postoperative pain ,Gynecologic laparoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine HydrochlorideDrug
Also called 0.5% Marcaine
0.5 Bupivacaine hydrochloride were port site infiltration preincision and preclosure injection
| Study group | Role | What they receive |
|---|---|---|
| placebo group | Placebo comparator | 0.9%Nacl (Placebo) 10 ml were port site infiltration prior skin incision and prior skin closure Drug: 0.9%Nacl Other Name: NSS Receives: Drug: Bupivacaine Hydrochloride |
| Preincision Bupivacaine | Experimental | 0.5% bupivacaine 10 ml (50 mg) were port site infiltration prior skin incision and 0.9%Nacl (Placebo) 10 ml were port site infiltration prior skin closure Drug: 0.5% bupivacaine 10 ml (50 mg) Other Name: Marcaine 0.9%Nacl (Placebo) 10 ml Other Name: NSS Receives: Drug: Bupivacaine Hydrochloride |
| Preclosure bupivacaine | Experimental | 0.9%Nacl (Placebo) 10 ml were port site infiltration prior skin incision and 0.5% bupivacaine 10 ml (50 mg) were port site infiltration prior skin closure Other Name: Marcaine Receives: Drug: Bupivacaine Hydrochloride |
| Bupivacaine group | Experimental | 0.5% bupivacaine 10 ml (50 mg) were port site infiltration prior skin incision and 0.5% bupivacaine 10 ml (50 mg) were port site infiltration prior skin closure Other Name: Marcaine Receives: Drug: Bupivacaine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain after surgery
Postoperative pain score in intervention and placebo groups
Measured: 24-48 hours after surgery
Secondary outcomes (2)
Among of pethidine use
Among of pethidine use to reduced postoperative pain
Measured: within 48 hours
Duration of hospital stay
Duration of hospital stay after surgery
Measured: within 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start1 Apr 2017
- Primary completion30 Oct 2017
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain ScoreStudies 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
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03259243
- Sponsor's protocol ID
- RAJLAPGYNE
- Status last verified
- Aug 2017
- First submitted
- 19 Aug 2017
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Port Site Infiltration With Bupivacaine for Reduction of Postoperative Pain in Woman Undergoing Gynecologic Laparoscopy: A Randomized, Factorial, Double-Blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT03259243
- Acronym / sponsor ID
- RAJLAPGYNE
- Conditions
- Postoperative Pain Score
- Keywords
- Bupivacaine, Port site infiltration ,Postoperative pain ,Gynecologic laparoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 30 Oct 2017 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 23 Aug 2017 (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.
To comparison of efficacy of Bupivacaine for relief postoperative pain in women undergoing laparoscopic gynecologic surgery
Detailed description
Gynecologic laparoscopic procedures have become more common nowadays because of their benefits in less tissue trauma, less perioperative morbidity and shorter hospital stays compared with laparotomy. But postoperative pain still be the most concerning problems including discomfort at incision sites, Pain due to pneumoperitoneum stretching the intraabdominal cavity and dissection of the abdominal and pelvic viscera.
Visceral pain is at maximal intensity during the first postoperative hours and is exacerbated by coughing, respiratory movements, and mobilization. Because the pain comprises of several factors, multimodal analgesic techniques are needed for effective postoperative analgesia and brought to this study to compare efficacy of Bupivacaine for pain relief postoperatively in women undergoing gynecologic laparoscopic surgery divided into 4 groups including preincision and preclosure Bupivacaine injection collated with placebo group. The result is measurement in postoperative pain score and amount of drug that using to reduce pain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| placebo group | Placebo comparator | Drug: Bupivacaine Hydrochloride0.9%Nacl (Placebo) 10 ml were port site infiltration prior skin incision and prior skin closure Drug: 0.9%Nacl Other Name: NSS |
| Preincision Bupivacaine | Experimental | Drug: Bupivacaine Hydrochloride0.5% bupivacaine 10 ml (50 mg) were port site infiltration prior skin incision and 0.9%Nacl (Placebo) 10 ml were port site infiltration prior skin closure Drug: 0.5% bupivacaine 10 ml (50 mg) Other Name: Marcaine 0.9%Nacl (Placebo) 10 ml Other Name: NSS |
| Preclosure bupivacaine | Experimental | Drug: Bupivacaine Hydrochloride0.9%Nacl (Placebo) 10 ml were port site infiltration prior skin incision and 0.5% bupivacaine 10 ml (50 mg) were port site infiltration prior skin closure Other Name: Marcaine |
| Bupivacaine group | Experimental | Drug: Bupivacaine Hydrochloride0.5% bupivacaine 10 ml (50 mg) were port site infiltration prior skin incision and 0.5% bupivacaine 10 ml (50 mg) were port site infiltration prior skin closure Other Name: Marcaine |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patient who undergoing gynecologic laparoscopic surgery
- Patient who agrees to participate in this study
- Patient able to speak and understand Thai
- Patient able to complete the questionnaire
Key exclusion criteria (5 listed)
- Patient with history of allergy in any kind anesthetic drug
- Patient who pregnant
- Patient who sign for single port gynecologic laparoscopic surgery or NOTE surgery
- Patient whom the surgery is withhold or canceled
- Patient whom the surgery is converted to laparotomy
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 |
|---|---|---|
| Bupivacaine HydrochlorideAlso: 0.5% Marcaine0.5 Bupivacaine hydrochloride were port site infiltration preincision and preclosure injection | Drug | Bupivacaine group, Preclosure bupivacaine, Preincision Bupivacaine, placebo group |
Primary outcome
Postoperative pain after surgery
Time frame: 24-48 hours after surgery
Postoperative pain score in intervention and placebo groups
2 secondary outcomes
Among of pethidine use
Time frame: within 48 hours
Duration of hospital stay
Time frame: within 7 days
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 Oct 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Bupivacaine Hydrochloride in people with Postoperative Pain Score, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
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 4 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 22 Oct 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 Thailand. 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?
Postoperative pain after surgery (time frame: 24-48 hours after surgery). 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 22 Oct 2020.