Postoperative PainNCT02649179
Local Infiltration With Ropivacaine Improves Postoperative Pain Control in Patients
A study testing Ropivacaine and 0.9% saline in people with Postoperative Pain, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
The purpose of this study is to evaluate the effect of pain relief after infusion of ropivacaine at port sites at end of laparoscopic cholecystectomy (LC)compared with placebo (0.9% normal saline). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Ropivacaine and 0.9% saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Sep 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male, and any race, Age≥18 years at the screening visite.
- ASA physical status I to II.
- Scheduled to undergo laparoscopic cholecystectomy under general anesthesia.
- Famale subjects must be without pregnancy.
- Ability to provide informed consent, adhere to the study visite schedule, and complete all study assessments.
Who cannot join
- Boss mass index >35kg/㎡
- Under intravertebral anesthesia and/or epidural analgesia
- Under postoperatived patient-controlled epidural analgesia (PCEA) and postoperative intravenous analgesia(PCIA).
- Inability to understand and use the visual analog scale (VAS)
- Currently pregnant,nursing,or planning to become pregnant during the study or within one month after study drug administration.
- Chronic user of analgesic medications, including taking opioid medications for more than 14 days in the last 3months,or non-opioid pain medications more than 5 times per week.
Show all 11Show fewer
- Proven or suspected allergy to local anesthetics ,NSAIDs and opioids .
- Use of any NSAIDs including selective COX-2 inhibitor , opioids or other analgesic agents within 3days of surgery.
- History of suspected or known addiction to or abuse of drugs or alcohol within the past 2 years.
- Current acute or chronic medical or major psychiatric disease that,in the opinion of the investigator ,would interfere with the evaluation of study drug efficacy or safety.
- Any other subjects were not suitable to this study in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710032
About this study
Official title: Local Infiltration With Ropivacaine Improves Postoperative Pain Control in Patients Undergoing Laparoscopic Cholecystectomy: a Prospective, Randomized, Placebo Controlled, Double-blind Trial
The purpose of this study is to evaluate the effect of pain relief after infusion of ropivacaine at port sites at end of laparoscopic cholecystectomy (LC)compared with placebo (0.9% normal saline).
Read the detailed description
Patients were randomly assigned to two groups, On Day 1,each subject was to undergo laparoscopic cholecystectomy under general anesthesia. Anesthesia will be induced with fentanly (2-4ug/kg), propofol TCI (4ug/ml), rocuronium (0.6mg/kg), and maintaine with remifentanly(0.1-0.3ug/kg.h) , and propofol TCI (3-5ug/ml). At the end of the operation before wound closure, patients were randomized 1:1 to receive ropivacaine or placebo. In study group all wounds were infiltrated with 0.75% ropivacaine 14ml at port sites before wound closure(6ml for epigastric port ,6ml for umbilical port ,and 4ml for working port) . The study drugs will be applied to the skin, subcutis, fascia, and parietal peritoneum through the port sites at the end of surgery. All anesthetics will be stopped when wound infiltration completed. Patients will be send to PACU for monitor a while then back to ward. Record of pain intensity evaluation and rescue analgesic medication consumption were to continue through 48hours after administration of study drug. Pain intensity will be assessed by using a 0-10 point VAS scale. VAS-rest and VAS-coughing were recorded at the baseline ,2,4,6,8,12,18,24,48 hours. Postoperative Rescue analgesia consisit of Parecoxib Sodium 40mg be given by a nurse on requst of the subject to a maximum of 80mg per day.
- Conditions
- Postoperative Pain
- Being tested
- Ropivacaine, 0.9% saline
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called Naropin
All wounds were infiltrated with 0.75% ropivacaine 14ml at port sites before wound closure(6ml for epigastric port ,6ml for umbilical port ,and 4ml for working port) . The study drugs will be applied to the skin, subcutis, fascia, and parietal peritoneum through the port sites at the end of surgery.
0.9% salineDrug
Also called saline
All wounds were infiltrated with 0.9% saline 14ml at port sites before wound closure(6ml for epigastric port ,6ml for umbilical port ,and 4ml for working port) . The study drugs will be applied to the skin, subcutis, fascia, and parietal peritoneum through the port sites at the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| local infiltration with ropivacaine | Experimental | patients were to receive 0.75% ropivacaine Receives: Drug: Ropivacaine |
| local infiltration with 0.9% saline | Placebo comparator | patients were to receive placebo Receives: Drug: 0.9% saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The area under the curve of visual analog scale (VAS) pain intensity scores at rest through 24h postoperative
Measured: 0-24h postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startAug 2016
- Primary completionJun 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhihong LU, Air Force Military Medical University, China
- Investigators
- Zhihong Lu, MD, Principal investigator, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02649179
- Sponsor's protocol ID
- XJH-A-ESR-14-10228
- Status last verified
- Jul 2018
- First submitted
- 6 Jan 2016
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Infiltration With Ropivacaine Improves Postoperative Pain Control in Patients Undergoing Laparoscopic Cholecystectomy: a Prospective, Randomized, Placebo Controlled, Double-blind Trial
- ClinicalTrials.gov ID
- NCT02649179
- Acronym / sponsor ID
- XJH-A-ESR-14-10228
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 7 Jan 2016 (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 is to evaluate the effect of pain relief after infusion of ropivacaine at port sites at end of laparoscopic cholecystectomy (LC)compared with placebo (0.9% normal saline).
Detailed description
Patients were randomly assigned to two groups, On Day 1,each subject was to undergo laparoscopic cholecystectomy under general anesthesia. Anesthesia will be induced with fentanly (2-4ug/kg), propofol TCI (4ug/ml), rocuronium (0.6mg/kg), and maintaine with remifentanly(0.1-0.3ug/kg.h) , and propofol TCI (3-5ug/ml). At the end of the operation before wound closure, patients were randomized 1:1 to receive ropivacaine or placebo. In study group all wounds were infiltrated with 0.75% ropivacaine 14ml at port sites before wound closure(6ml for epigastric port ,6ml for umbilical port ,and 4ml for working port) . The study drugs will be applied to the skin, subcutis, fascia, and parietal peritoneum through the port sites at the end of surgery. All anesthetics will be stopped when wound infiltration completed. Patients will be send to PACU for monitor a while then back to ward. Record of pain intensity evaluation and rescue analgesic medication consumption were to continue through 48hours after administration of study drug. Pain intensity will be assessed by using a 0-10 point VAS scale. VAS-rest and VAS-coughing were recorded at the baseline ,2,4,6,8,12,18,24,48 hours. Postoperative Rescue analgesia consisit of Parecoxib Sodium 40mg be given by a nurse on requst of the subject to a maximum of 80mg per day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| local infiltration with ropivacaine | Experimental | Drug: Ropivacainepatients were to receive 0.75% ropivacaine |
| local infiltration with 0.9% saline | Placebo comparator | Drug: 0.9% salinepatients were to receive placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female or male, and any race, Age≥18 years at the screening visite.
- ASA physical status I to II.
- Scheduled to undergo laparoscopic cholecystectomy under general anesthesia.
- Famale subjects must be without pregnancy.
- Ability to provide informed consent, adhere to the study visite schedule, and complete all study assessments.
Key exclusion criteria (11 listed)
- Boss mass index >35kg/㎡
- Under intravertebral anesthesia and/or epidural analgesia
- Under postoperatived patient-controlled epidural analgesia (PCEA) and postoperative intravenous analgesia(PCIA).
- Inability to understand and use the visual analog scale (VAS)
- Currently pregnant,nursing,or planning to become pregnant during the study or within one month after study drug administration.
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 |
|---|---|---|
| RopivacaineAlso: NaropinAll wounds were infiltrated with 0.75% ropivacaine 14ml at port sites before wound closure(6ml for epigastric port ,6ml for umbilical port ,and 4ml for working port) . The study drugs will be applied to the skin, subcutis, fascia, and parietal peritoneum through the port sites at the end of surgery. | Drug | local infiltration with ropivacaine |
| 0.9% salineAlso: salineAll wounds were infiltrated with 0.9% saline 14ml at port sites before wound closure(6ml for epigastric port ,6ml for umbilical port ,and 4ml for working port) . The study drugs will be applied to the skin, subcutis, fascia, and parietal peritoneum through the port sites at the end of surgery. | Drug | local infiltration with 0.9% saline |
Primary outcome
The area under the curve of visual analog scale (VAS) pain intensity scores at rest through 24h postoperative
Time frame: 0-24h postoperative
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 26 Jul 2018.
- Individual participant dataSharing planned: No
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Zhihong Lu, MD principal investigator
Air Force Military Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine and 0.9% saline in people with Postoperative Pain, run by Air Force Military Medical University, China 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 5 inclusion and 11 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 26 Jul 2018. 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.
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 area under the curve of visual analog scale (VAS) pain intensity scores at rest through 24h postoperative (time frame: 0-24h postoperative). 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 26 Jul 2018.