Patient-Controlled AnalgesiaNCT03221491

Comparison of Patient-Controlled Analgesia With Different Background Infusion

A study of Patient-Controlled Analgesia, run by Weifeng Tu at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

In this study, the investigators investigated the efficacy, usefulness and analgesic consumption of three different patient-controlled analgesia(PCA) programmes:bolus dose alone without background infusion, bolus dose with low background infusion and bolus dose with high background infusion to evaluate postoperative… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Patient-Controlled Analgesia
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: 1 siteChina
Study dates: 1 Jul 2016to 30 Jun 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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

American Society of Anesthesiologists(ASA) Ⅰ-Ⅱ patient undergoing laparoscopic colorectal surgery
Written informed consent from the patient or the relatives of the participating patient.
BMI:18～30kg/m2

Who cannot join

Mental illness or cannot communicate.;
A second operation during the study;
Lung infection or sleep apnea syndrome;
Renal failure;
Alcohol or drug abuse;
Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug;
Long-term use of analgesics,sedatives or non steroidal anti-inflammatory drugs history .

Trial locations and contacts

1 site in 1 country.

China1 site

Guangzhou General Hospital of Guangzhou Military Command
Guangzhou, Guangdong, 510010

Other trials in China

About this study

Official title: Comparison of Intravenous Patient-Controlled Analgesia With Different Background Infusion After Colorectal Surgery

Read the detailed description

There have been many studies using patient-controlled analgesia (PCA) and opioids for postoperative analgesia.Patient-controlled analgesia with opioids is now widely used after surgery for the treatment of acute postoperative pain. This technique provides effective pain treatment, adjusts the dose according to personal need and keeps plasma analgesic levels at a constant level,but the incidence of opioid-induced side-effects still be reported frequently.A proper PCA programme may increase efficiency of analgesic and decrease incidence of analgesic-induced side-effects.

In this study, 90 patients who is undergoing elective laparoscopic colorectal surgery will be randomly allocated into three groups (no background infusion group(Group B0),low background infusion group(Group B1) and high background infusion group(Group B2)). Patients in all groups will be given a patient-controlled analgesia (PCA) pump in post anesthetic recovery unit (PACU) after surgery.The PCA programme of Group B0 is dezocine 0.6mg/kg, flubiprofen 3mg/kg, diluted into 120ml and administer at a background infusion of 0ml/h, and a bolus of 4ml, with a lock-out of 15min. The PCA protocol of Group B1 is dezocine 0.6mg/kg,flubiprofen 3mg/k diluted into 120ml and administer at a background infusion of 1ml/h, and a bolus of 2ml, with a lock-out of 15min.The PCA protocol of Group B2 is dezocine 0.6mg/kg,flubiprofen 3mg/k diluted into 120ml and administer at a background infusion of 2ml/h, and a bolus of 2ml, with a lock-out of 15min.

Conditions: Patient-Controlled Analgesia
Being tested: Patient-Controlled Analgesia(PCA)
Keywords: Analgesia, Colorectal Surgery, Background Infusion
Medical subject headings: Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Patient-Controlled Analgesia(PCA)Device
Patients receive analgesic regimens using Patient-Controlled Analgesia(PCA) with different background infusion.

Study groups in NCT03221491
Study group	Role	What they receive
No Background Infusion Group(Group B0)	Experimental	Patients in Group B0 receive analgesic regimens using Patient-Controlled Analgesia(PCA) with background infusion 0ml/h. Receives: Device: Patient-Controlled Analgesia(PCA)
Low Background Infusion Group(Group B1)	Experimental	Patients in Group B1 receive analgesic regimens using Patient-Controlled Analgesia(PCA) with background infusion 1ml/h. Receives: Device: Patient-Controlled Analgesia(PCA)
High Background Infusion Group(Group B2)	Experimental	Patients in Group B2 receive analgesic regimens using Patient-Controlled Analgesia(PCA) with background infusion 2ml/h. Receives: Device: Patient-Controlled Analgesia(PCA)

What is being measured

The primary outcome is the main question the study is designed to answer.

Dezocine consumption by patient-controlled analgesia
The total consumption of dezocine during 24 hours after surgery are recorded.
Measured: At 24 hours after surgery

Secondary outcomes (3)

The incidence rates of postoperative nausea and vomiting (PONV)
Measure whether nausea and vomiting exist and the level of severity.
Measured: At 24 hours and 48 hours after surgery
Change in ramsay sedation score
Measure sedation level by using ramsay sedation score.
Measured: At 0, 2, 4, 8, 24, 48 and 72 hours after surgery
Change in pain score
Pain scores at rest and movement are evaluated with a numeric rating scale (NRS)
Measured: At 0, 2, 4, 8, 24, 48 and 72 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 201630 Jun 2017

First posted18 Jul 2017
Study start1 Jul 2016
Primary completion30 Jun 2017
Study completion30 Jun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Patient-Controlled AnalgesiaStudies 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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03221491
Sponsor's protocol ID: Different Background Infusion
Status last verified: Jul 2017
First submitted: 16 Jul 2017
Last updated: 21 Jul 2017
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Doyle E, Harper I, Morton NS. Patient-controlled analgesia with low dose background infusions after lower abdominal surgery in children. Br J Anaesth. 1993 Dec;71(6):818-22. doi: 10.1093/bja/71.6.818.
PubMed 8280546
Yildiz K, Tercan E, Dogru K, Ozkan U, Boyaci A. Comparison of patient-controlled analgesia with and without a background infusion after appendicectomy in children. Paediatr Anaesth. 2003 Jun;13(5):427-31. doi: 10.1046/j.1460-9592.2003.01061.x.
PubMed 12791117
White I, Ghinea R, Avital S, Chazan S, Dolkart O, Weinbroum AA. Morphine at "sub-analgesic" background infusion rate plus low-dose PCA bolus control pain better and is as safe as twice a bolus-only PCA regimen: a randomized, double blind study. Pharmacol Res. 2012 Aug;66(2):185-91. doi: 10.1016/j.phrs.2012.03.016. Epub 2012 Apr 6.
PubMed 22504462
Hayes J, Dowling JJ, Peliowski A, Crawford MW, Johnston B. Patient-Controlled Analgesia Plus Background Opioid Infusion for Postoperative Pain in Children: A Systematic Review and Meta-Analysis of Randomized Trials. Anesth Analg. 2016 Oct;123(4):991-1003. doi: 10.1213/ANE.0000000000001244.
PubMed 27065359

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Patient-Controlled Analgesia trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Intravenous Patient-Controlled Analgesia With Different Background Infusion After Colorectal Surgery
ClinicalTrials.gov ID: NCT03221491
Acronym / sponsor ID: Different Background Infusion
Conditions: Patient-Controlled Analgesia
Keywords: Analgesia, Colorectal Surgery, Background Infusion
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Weifeng TuUniversity, hospital or other
Study start: 1 Jul 2016 (actual)
Primary completion: 30 Jun 2017 (actual)
Study completion: 30 Jun 2017 (actual)
First posted: 18 Jul 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.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
No Background Infusion Group(Group B0)	Experimental	Device: Patient-Controlled Analgesia(PCA)Patients in Group B0 receive analgesic regimens using Patient-Controlled Analgesia(PCA) with background infusion 0ml/h.
Low Background Infusion Group(Group B1)	Experimental	Device: Patient-Controlled Analgesia(PCA)Patients in Group B1 receive analgesic regimens using Patient-Controlled Analgesia(PCA) with background infusion 1ml/h.
High Background Infusion Group(Group B2)	Experimental	Device: Patient-Controlled Analgesia(PCA)Patients in Group B2 receive analgesic regimens using Patient-Controlled Analgesia(PCA) with background infusion 2ml/h.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

American Society of Anesthesiologists(ASA) Ⅰ-Ⅱ patient undergoing laparoscopic colorectal surgery
Written informed consent from the patient or the relatives of the participating patient.
BMI:18～30kg/m2

Key exclusion criteria (7 listed)

Mental illness or cannot communicate.;
A second operation during the study;
Lung infection or sleep apnea syndrome;
Renal failure;
Alcohol or drug abuse;

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
Patient-Controlled Analgesia(PCA)Patients receive analgesic regimens using Patient-Controlled Analgesia(PCA) with different background infusion.	Device	High Background Infusion Group(Group B2), Low Background Infusion Group(Group B1), No Background Infusion Group(Group B0)

Primary outcome

Dezocine consumption by patient-controlled analgesia
Time frame: At 24 hours after surgery
The total consumption of dezocine during 24 hours after surgery are recorded.

3 secondary outcomes

The incidence rates of postoperative nausea and vomiting (PONV)
Time frame: At 24 hours and 48 hours after surgery
Change in ramsay sedation score
Time frame: At 0, 2, 4, 8, 24, 48 and 72 hours after surgery
Change in pain score
Time frame: At 0, 2, 4, 8, 24, 48 and 72 hours 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 21 Jul 2017.
Background: PubMed 8280546Doyle E, Harper I, Morton NS. Patient-controlled analgesia with low dose background infusions after lower abdominal surgery in children. Br J Anaesth. 1993 Dec;71(6):818-22. doi: 10.1093/bja/71.6.818.
Background: PubMed 12791117Yildiz K, Tercan E, Dogru K, Ozkan U, Boyaci A. Comparison of patient-controlled analgesia with and without a background infusion after appendicectomy in children. Paediatr Anaesth. 2003 Jun;13(5):427-31. doi: 10.1046/j.1460-9592.2003.01061.x.
Background: PubMed 22504462White I, Ghinea R, Avital S, Chazan S, Dolkart O, Weinbroum AA. Morphine at "sub-analgesic" background infusion rate plus low-dose PCA bolus control pain better and is as safe as twice a bolus-only PCA regimen: a randomized, double blind study. Pharmacol Res. 2012 Aug;66(2):185-91. doi: 10.1016/j.phrs.2012.03.016. Epub 2012 Apr 6.
Background: PubMed 27065359Hayes J, Dowling JJ, Peliowski A, Crawford MW, Johnston B. Patient-Controlled Analgesia Plus Background Opioid Infusion for Postoperative Pain in Children: A Systematic Review and Meta-Analysis of Randomized Trials. Anesth Analg. 2016 Oct;123(4):991-1003. doi: 10.1213/ANE.0000000000001244.
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 study of Patient-Controlled Analgesia, run by Weifeng Tu 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 7 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 21 Jul 2017. 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. 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?

Dezocine consumption by patient-controlled analgesia (time frame: At 24 hours 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 NCT03221491, which also lists 4 linked publications.

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 21 Jul 2017.