The efficacy, safety and cost-effectiveness analysis of morphine and hydromorphone in intrathecal drug deliver system for intractable cancer pain

ISRCTN ISRCTN17751043
DOI https://doi.org/10.1186/ISRCTN17751043
Secondary identifying numbers N/A
Submission date
03/01/2016
Registration date
26/01/2016
Last edited
02/02/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Intractable cancer pain (that is pain that is resistant to the effects of painkillers) is a difficult medical problem. Intrathecal analgesia (that is, painkiller injected into the spinal cord) has emerged as a key therapeutic option for pain relief for patients for which other treatment avenues have not worked as well as patients on high doses of analgesia (painkiller) suffering from unacceptable side effects. Hydromorphone, is a opiod drug with effects similar to that of morphine, but is more potent and acts more quickly due to its greater lipophilic properties (that is, it is more able to dissolve in lipids, or fats). But the comparison between hydromorphone and morphine in how well they work (efficacy), safety, and pharmacoeconomics analysis research (that is, comparing the value of one drug compared to another) is rare in China. The aims of this study was to observe the effects, security and pharmacoeconomics of morphine and hydromorphone in the treatment of intractable cancer pain.

Who can participate?
Adults with cancer suffering from intractable cancer pain

What does the study involve?
Participants are randomly allocated to one of two groups. Those in group 1 are given hydromorphone via a intrathecal catheter. Those in group 2 are given morphine via a intrathecal catheter. The pain experienced after treatment is assessed for each patient every day for the next 3 months.

What are the possible benefits and risks of participating?
The immediate direct benefit to those taking part is better pain management and a free intrathecal drug delivery system (IDDs). After treatment, patients’ quality of life may improve. The main risk of this study is surgical complications from inserting the intrathecal catheter including bleeding, neurological injury, infection, cerebrospinal fluid (CSF) leakage and shredded catheters.

Where is the study run from?
Pain Management Department, Xinhua Hospital (affiliated to Shanghai Jiaotong University, School of Medicine)

When is the study starting and how long is it expected to run for?
December 2015 to December 2016

Who is funding the study?
Chinese association for the study of pain, the minimally invasive interventional group

Who is the main contact?
Professor Ke MA
marke72@163.com

Contact information

Prof Ke MA
Scientific

Pain Management Centre
Xinhua Hospital (affiliated with Shanghai Jiaotong University, School of Medicine)
No 1665, Kongjiang Road
Yangpu District
Shanghai
2000092
China

ORCiD logoORCID ID 0000-0002-5603-9321
Phone +86 13651663779
Email marke72@163.com

Study information

Study designMuiticenter single-blinded randomized controlled clinical study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleThe efficacy, safety and cost-effectiveness analysis of morphine and hydromorphone in intrathecal drug deliver system for intractable cancer pain:a multicenter, randomized single-blind, controlled study.
Study objectives1. Morphine and hydromorphone are effective and safe when administered using the intrathecal drug delivery system for intractable cancer pain patients.
2. Morphine and hydromorphone administered using the intrathecal drug delivery system can improve the quality of life and reduce the oral pain-related drugs dosage of cancer pain patients.
Ethics approval(s)Xinhua hospital Ethics Committee Affiliated to Shanghai Jiaotong University School of Medicine, 08/09/2015, ref: XHEC-C -2015-018-2
Health condition(s) or problem(s) studiedCancer pain
InterventionAn intrathecal catheter is placed at the L4/5 or L3/4 level and the catheter is passed under fluoroscopic guidance to the T10 or T11 vertebral level. Then, a tunneled subcutaneous catheter plus a subcutaneous port, with an external infusion pump system were implanted.

240 patients with cancer pain were randomized and assigned into 2 equal groups:
1. Hydromorphone group (n = 120)
2. Morphine group (n = 120)
The duration of follow-up is 3 months post-treatment.
Intervention typeProcedure/Surgery
Primary outcome measure1. Pain after treatment, measured using the visual analogue score (VAS) every day during 3 months after treatment
2. Drug cost-effectiveness at 1, 2 and 3 months after treatment
Secondary outcome measures1. The frequency, duration and degree of the flare pain everyday during 3 months after treatment
2. Intensity of anxiety experienced by patient. measured using the PHQ - 9 evaluation scale at 1, 2 and 3months after treatment
3. Intensity of depression experienced by patient, measured by the GAD - 7 anxiety screening scale) at 1, 2 and 3months after treatment
4. Quality of life measured by the quality of life score (SF - 36) at 1, 2 and 3 months after treatment
Overall study start date01/12/2015
Completion date31/12/2016

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants240
Key inclusion criteriaCancer pain
Key exclusion criteria1. Researchers think that there is any reason can't include
2. IDDS procedure contraindications
3. Uncooperative and unable to finish the self evaluation (PHQ - 9, GAD - 7 and SF-36)
4. Spinal deformity, intolerance to operation
5. The central infection, severe systemic infection
6. The blood coagulation dysfunction; severe liver and kidney dysfunction
7. Patient who has a history of drug abuse
Date of first enrolment01/12/2015
Date of final enrolment30/12/2016

Locations

Countries of recruitment

  • China

Study participating centres

Pain Management Department, Xinhua Hospital affiliated to Medical School of Shanghai Jiaotong University
No 1995 Kongjiang Road
Shanghai
200092
China
Pain Medicine Center, Nanjing Jinling Hospital,
No.305 Zhongshan East Road
Nanjing
210002
China
Tiantan Hospital, Pain Department
No 6, West Tiantan Road
Dongcheng District
Beijing
100050
China
Xijing Hospital, Pain Management Department
No 127, West Changle Road
Xi'an
710032
China
The First Affiliated Hospital, China Medical University
Department of Pain Medicine
No 155,North Nanjing Road
Heping District
Shenyang
110001
China
The First Hospital affiliated to Medical School of Zhejiang University
Pain Management Department
NO 79,Qingchun Road
Hangzhou
310003
China
Gulou Hospital
Pain Management Department
No 321, Zhongshan Road
Nanjing
210008
China
The People's Hospital of Qinghai Province
Pain Management Department
No.2, Gonghe Road
Xi‘ning
810007
China
The First Hospital affiliated to Chongqing Medical College
No 1, Youyi Road
Yuan jiaguang, Yu Zhong Distric
Chongqing
400016
China
The 2nd affiliated Hospital of Kunming Medical College
Pain Management Department
No 1, Dian Mian Road.
Kunming
650000
China
The Tenth Hospital affiliated to Tongji University
Department of Anesthesiology
No 301,Yanchang Road
Shanghai
200072
China
Tumor Hospital of Hennan province
Department of Pain Medicine
No 127 Dongming Road
Zhengzhou
450008
China

Sponsor information

Chinese association for the study of pain, the minimally invasive interventional group
Research organisation

No 6, The West Tiantan Road
Chongwen district
Beijing
100050
China

Phone +86 13361879260
Email marke72@sjtu.edu.cn
ROR logo "ROR" https://ror.org/03tygvc25

Funders

Funder type

Research organisation

Chinese association for the study of pain, the minimally invasive interventional group

No information available

Results and Publications

Intention to publish date30/06/2017
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planThe clinical trial will be finished at Mar 2017, and the paper will be finished and contributed to an appropriate journal in Jun 2017.
IPD sharing plan

Editorial Notes

02/02/2016: Internal review