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Trial registered on ANZCTR


Registration number
ACTRN12618000643279
Ethics application status
Not required
Date submitted
1/02/2018
Date registered
23/04/2018
Date last updated
23/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Postoperative pain after open cholecystectomy
Scientific title
Postoperative pain in diabetic patients following open cholecystectomy
Secondary ID [1] 288312 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cholelithiasis 299639 0
Diabetes 299640 0
postoperative pain 299641 0
Condition category
Condition code
Anaesthesiology 299590 299590 0 0
Pain management
Metabolic and Endocrine 305815 305815 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients without or with type 2 diabetes diagnosed with chronic cholecystitis and scheduled for elective open cholecystectomy will be studied.
All patients will receive a general anaesthetic and maintained with sevoflurane 1.5% and fentanyl 5 µg/kg. Patients also receive diclofenac 75 mg i.v. once before the surgical incision.
Haemodynamic variables were defined as: hypotension (MAP < 60 mmHg), hypertension (MAP > 100 mmHg), bradycardia (heart rate < 40 beats/min) and tachycardia (heart rate > 90 beats/min).
After completion of the surgical procedure (final suture) and emergence from anaesthesia, all patients will be transferred to the recovery room.
Duration of surgery was defined as the time from skin incision to completion of skin suturing. Onset of postoperative pain was defined as the time from end of anaesthesia until presence of any postoperative pain score. Pain management will be immediately after assessment according to institutional standards.
Postoperative pain will be evaluated by using a 0–10 numerical rating scale (NRS) (0 = no pain and 10 = worst pain imaginable), and onset of postoperative pain will be defined as the time from end of anaesthesia until presence of any postoperative pain score. Each
participants will be observed for at least 8 hours post-surgery,

Intervention code [1] 300918 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299082 0
Primary outcome 1: Pain score at onset of postoperative pain assessed by using a 0–10 numerical rating scale (NRS).
Timepoint [1] 299082 0
The intensity of the pain will be evaluated and will be recorded when the patient is already in the recovery room and shows any pain score. The evaluation will be for a maximum of 8 hours.
Secondary outcome [1] 326089 0
Time of onset of postoperative pain. This outcome will be evaluated as reported by the patient and will be recorded in the data collection sheet by a researcher blinded to the study.
Timepoint [1] 326089 0
Time from end of anaesthesia until presence of any postoperative pain score
Secondary outcome [2] 343536 0
Duration of surgery. This outcome will be evaluated through nursing records and the study data sheet.
Timepoint [2] 343536 0
It will be the time elapsed from the moment of the incision of the skin until completing the suture of the skin. According to the experience of the surgeons and the literature data will be about 1 hour.

Eligibility
Key inclusion criteria
Patients diagnosed with chronic cholecystitis and scheduled for elective open cholecystectomy.
Age > 18yr
Weight > 40 kg
American Society of Anesthesiology physical status (ASA) I, II or III.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergy to non-steroidal anti-inflammatory drugs or diclofenac
History of peptic ulcer disease
Haemorrhagic diathesis, coronary heart disease
Bronchial asthma
Seizure disorders, pregnancy or any others contraindications

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Age, height, weight, BMI, glucose concentration, duration of surgery, time to onset postoperative pain and NRS values will be recorded. Analysis will be done by mean comparison with the Student´s t-test. Nominal data (sex, ASA, pain intensity) between the two groups will be compared by the Chi-square test or Fisher´s exact test. All data will be presented as means ± S.E.M. or number and percentages. A p value < 0.05 will be considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8057 0
Mexico
State/province [1] 8057 0
Tabasco

Funding & Sponsors
Funding source category [1] 294160 0
Hospital
Name [1] 294160 0
Hospital Regional de Alta Especialidad “Dr. Juan Graham Casasús”
Address [1] 294160 0
Calle Uno S/n con carretera Villahermosa- La Isla km. 1+300 Col. Miguel Hidalgo
C.P 86126
Villahermosa, Tabasco, México
Country [1] 294160 0
Mexico
Primary sponsor type
Hospital
Name
Hospital Regional de Alta Especialidad “Dr. Juan Graham Casasús”
Address
Calle Uno S/n con carretera Villahermosa- La Isla km. 1+300 Col. Miguel Hidalgo
Villahermosa Tabasco, México
C.P 86126
Country
Mexico
Secondary sponsor category [1] 292993 0
University
Name [1] 292993 0
Universidad Juárez Autónoma de Tabasco
Address [1] 292993 0
Av. Gregorio Méndez 2838-A
Col. Tamulté, CP 86150
Villahermosa, Tabasco, México
Country [1] 292993 0
Mexico

Ethics approval
Ethics application status
Not required

Summary
Brief summary
Pre-clinical studies have shown that experimental diabetes induces hyperalgesia in rodents. Additionally, diabetic patients report more postoperative pain after lumbar spine surgery or total abdominal hysterectomy than non-diabetic patients. Interestingly, some studies indicate that cholelithiasis is three times more frequent in diabetic than in non-diabetics patients. However, the comparison of postoperative pain after cholecystectomy between diabetic and non-diabetic patients remains unknown. Thus, the primary aim was evaluate the intensity of postoperative acute pain in diabetic patients undergoing open cholecystectomy.
Trial website
Trial related presentations / publications
Public notes
The study does not need to be evaluated by the research ethics committee, since it is not a new postoperative pain treatment. Patients will be treated with the conventional and institutional scheme already defined for the treatment of postoperative pain after open cholecystectomy. The study is observational, therefore only the intensity of pain in diabetic and non-diabetic patients will be recorded from their arrival in the recovery room until 8 hours later. If any of the patients manifest values of 3 or more on the NRS scale (moderate to severe) during the planned observation period, an analgesic rescue will be given and the pain and time scores will be recorded. The patient who had the above characteristics will no longer be observed.

Contacts
Principal investigator
Name 62722 0
Dr Jorge Elías Torres López
Address 62722 0
Jorge Elías Torres López
División Académica de Ciencias de la Salud
Universidad Juárez Autónoma de Tabasco
Av. Gregorìo Méndez No. 2838-A
Colonia Tamulté
C.P. 86100
Villahermosa, Tabasco, México
Country 62722 0
Mexico
Phone 62722 0
+5219933581500
Fax 62722 0
Email 62722 0
jorge.torres@ujat.mx
Contact person for public queries
Name 62723 0
Dr Jorge Elías Torres López
Address 62723 0
Jorge Elías Torres López
División Académica de Ciencias de la Salud
Universidad Juárez Autónoma de Tabasco
Av. Gregorìo Méndez No. 2838-A
Colonia Tamulté
C.P. 86100
Villahermosa, Tabasco, México
Country 62723 0
Mexico
Phone 62723 0
+5219933581500
Fax 62723 0
Email 62723 0
jorge.torres@ujat.mx
Contact person for scientific queries
Name 62724 0
Dr Jorge Elías Torres lópez
Address 62724 0
Jorge Elías Torres López
División Académica de Ciencias de la Salud
Universidad Juárez Autónoma de Tabasco
Av. Gregorìo Méndez No. 2838-A
Colonia Tamulté
C.P. 86100
Villahermosa, Tabasco, México
Country 62724 0
Mexico
Phone 62724 0
+5219933581500
Fax 62724 0
Email 62724 0
jorge.torres@ujat.mx

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary