Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00402

2 Trial Registration Date

2014-04-03

i Registration Status

Prospective

3 Secondary IDs

CRE-2011.495-T

4 Source(s) of Funding

Health and Medical research Fund

5 Primary Sponsor

The Chinese University of Hong Kong

6 Secondary Sponsor

N/A

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Matthew Chan

ii Address

c/-Department of Anaesthesia and Intensive Care, 4/F Main Clinical BLock and Trauma Center, Prince of Wales Hospital, Shatin, Hong Kong

iii Phone

2632 2736

iv Email

mtvchan@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Matthew Chan

ii Address

c/-Department of Anaesthesia and Intensive Care, 4/F Main Clinical BLock and Trauma Center, Prince of Wales Hospital, Shatin, Hong Kong

iii Phone

2632 2736

iv Email

mtvchan@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

Evaluation of Nitrous Oxide In the Gas Mixture for Anesthesia: A Randomized Controlled Trial for the Prevention of Chronic Pain After Major Abdominal Surgery

10 Public Title

ENIGMA Pain

i Public Title in Chinese 研究名稱

麻醉時使用氧化亞氮的隨機對照研究:一項預防腹部大手術後慢性疼痛发生的研究

11 Short Title (Optional)

ENIGMA Pain

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2011-12-06

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Chronic pain

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Nitrous oxide

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

During surgery

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

30%oxygen in air

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

(1) men or women aged ≥18 years
(2) American Society of Anesthesiologists physical status class 1-3
(3) major elective (open or laparoscopic) abdominal surgery, with an abdominal incision of at least 10 cm.

ii Exclusion Criteria

(1) acute bowel obstruction (contraindicated for N2O administration)
(2) marked impairment of gaseous exchange (usually due to severe chronic obstructive pulmonary disease, requiring inspired O2 concentration >40%).
(3) patients who plan to have a regional block for perioperative analgesia
(4) patients who are taking daily doses of opioids, tramadol, ketamine, gabanoids, tricyclic antidepressants, neuroleptics, serotonin reuptake inhibitors, COX2 inhibitors or other non-steroidal anti-inflammatory drugs 7 days before surgery
(5) atients who are not expected to be available for, or to cooperate with, interviews and those who refuse consent or who previously enrolled in the study

iii Age Minimum

18

iv Age Maximum

-

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2014-04-18

21 Target Sample Size

800

22 Recruitment Status

Unknown

23 Primary Outcome

Severe pain over the surgical site at 6 months after surgery

24 Secondary Outcome

(1) Any pain over the surgical site lasting for 6 months after surgery.
(2) Interference of chronic postsurgical pain with daily activities
(3) Impact of chronic postsurgical pain on general health status recorded by EQ-5D.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-05-05

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-14004470

28 Date of Registration in Primary Registry

2014-04-05

Back History

Trial Detail