Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000435583
Ethics application status
Approved
Date submitted
18/03/2015
Date registered
6/05/2015
Date last updated
6/05/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of a single dose preemptive pregabalin on acute and chronic pain after inguinal hernia repair with mesh under spinal anesthesia
Scientific title
The effects of a single dose preemptive pregabalin on acute and chronic pain after inguinal hernia repair with mesh under spinal anesthesia
Secondary ID [1] 286378 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute and chronic pain after inguinal hernia repair 294520 0
Condition category
Condition code
Anaesthesiology 294826 294826 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After obtaining the approval of the ethics committee, a prospective, randomized, and double-blind study was planned. A total of 60 patients, aged between 18-65 years and ASA I – II, who were planned to undergo inguinal hernia repair with mesh under spinal anesthesia were included in the study. Patients were randomly divided into two groups: in the pregabalin group (Group Pregabalin n=30), 150 mg of pregabalin was administered orally one hour before spinal anesthesia; in the other group (Group Placebo n=30), oral placebo capsule was given. Spinal anesthesia was administered with heavy bupivacaine and all operations were performed by the same surgeon, using the same technique. Postoperative analgesia was evaluated during resting and actively moving, using Visual Analogue Scale (VAS). The 24-hour consumption of fentanyl in patient-controlled analgesia, the initial time for administration of analgesics and requirement for additional analgesia were recorded. Assessments of chronic pain were made at postoperative 1st, 3rd, and 6th months.
Intervention code [1] 291442 0
Treatment: Drugs
Comparator / control treatment
Patients were randomly divided into two groups: in the control (Group Placebo n=30),oral placebo microcellulose tablet was given one hour before spinal anesthesia.
Control group
Placebo

Outcomes
Primary outcome [1] 294590 0
Postoperative pain. Postoperative analgesia was evaluated during resting and actively moving, using Visual Analogue Scale (VAS).
Timepoint [1] 294590 0
first 24 hours after operation
Primary outcome [2] 294788 0
duration of postoperative analgesia. Assessed with medical records.
Timepoint [2] 294788 0
first 24 hours after operation
Primary outcome [3] 294789 0
opioid consumption. Assessed with medical records
Timepoint [3] 294789 0
first 24 hours after operation
Secondary outcome [1] 313678 0
Our secondary aim was to determine the effect of pregabalin on chronic pain. Pain was assessed by numerical rating scale.
Timepoint [1] 313678 0
Numerical Rating Scale scores were assessed 1 months, 3 months and 6 months after operation.

Eligibility
Key inclusion criteria
18-65 years female and male
patients undergoing inguinal hernia repair with mesh under spinal anesthesia
ASA I – II
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with ASA III and over,
allergic to the active substance,
prescribed with anti-epileptic drugs,
severe hepatic or renal failure,
history of long-term usage of nonsteroidal anti-inflammatory and opioid analgesics,
diabetes mellitus and other neuropathic disorders,
unable to use patient controlled analgesia (PCA) device, contraindications for spinal anesthesia,

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size:
The primary outcome of the study was the total dose of fentanyl consumption in the 24-hour postoperative period. In our preliminary study, we found that the standard deviation was 201.71 in Group pregabalin and 289.59 in Group placebo. We aimed to detect a difference between the two groups was at least 200 mcg fentanyl consumption in the 24-hour postoperative period. Accordingly, we determined that the number of patients required in every group was 30, based on power of 86%, the alpha error of 0.05 by using Russ Lenth's Piface Java module.
Statistical Analysis:
IBM SPSS 20.0 (SPSS Inc., Chicago, Illinois, USA) software program was used to perform the statistical analysis. The distribution of the variables was evaluated for normality using the Kolmogorov-Smirnov and histogram tests. Descriptive statistics was expressed as the means ± standard deviation (SD). Categorical variables were analyzed using the chi-square test. The normally distributed data comprising continuous variables were analyzed using Student’s t-test. Otherwise, the Mann–Whitney U test was used. A value of P< 0.05 was considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/04/2014
Actual
1/05/2014
Date of last participant enrolment
Anticipated
1/11/2014
Actual
10/11/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 6757 0
Turkey
State/province [1] 6757 0
Erzurum

Funding & Sponsors
Funding source category [1] 290951 0
University
Name [1] 290951 0
Ataturk University
Country [1] 290951 0
Turkey
Primary sponsor type
University
Name
Ataturk University
Address
Department of Anaesthesiology and Reanimation,
Faculty of Medicine, Ataturk University, Erzurum, Turkey
Postal code: 25240
Country
Turkey
Secondary sponsor category [1] 289632 0
None
Name [1] 289632 0
None
Address [1] 289632 0
None
Country [1] 289632 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292550 0
Ethical committee of Ataturk University Medical Faculty
Ethics committee address [1] 292550 0
Vaniefendi district, Ataturk University Medical Faculty , Erzurum,Turkey
postal code:25240
Ethics committee country [1] 292550 0
Turkey
Date submitted for ethics approval [1] 292550 0
01/04/2014
Approval date [1] 292550 0
24/04/2014
Ethics approval number [1] 292550 0
Date:24/04/2014/ Number:5

Summary
Brief summary
Postoperative pain is an acute pain, accompanied by the inflammatory process manifested due to the surgical trauma and progressively decreasing with ongoing tissue healing. A successful postoperative analgesia is well known to prevent many adverse effects of pain such as inability to breathe comfortably, increased workload of cardiovascular system, development of thromboembolic events due to delayed mobilization, increased stress response due to the activation of neuroendocrine and sympathetic nervous systems.
In experimental studies, it has been shown that implementation of analgesia prior to surgical trauma might have reduced the posttraumatic sensitivity of the spinal cord and secondary hyperalgesia. Since peripheral hypersensitivity and central nervous system hyperexcitability might have developed if analgesic treatment is initiated after the painful stimulus, difficulties may be encountered in postoperative pain management in such cases.
Pregabalin is a structural gamma-aminobutyric acid (GABA) analog. Its mechanism of action is not fully understood. Pregabalin is suggested to modulate the presynaptic release of excitatory neurotransmitters by binding to the a2-d protein subunit of voltage-sensitive calcium channels in the central nervous system. Pregabalin reduces the release of numerous neurotransmitters, including glutamate, noradrenaline, substance P, and calcitonin gene-related peptide. Conducted studies have shown that pregabalin might have a role in postoperative pain management.
In many countries, inguinal hernia repair is the most frequently performed operation in general surgery. Each year, approximately 20.000.000 inguinal hernia repairs are made worldwide. Meshes, which are used in hernia repair, may lead to both acute and chronic pain development by increasing the inflammatory response. The incidence of postoperative chronic pain is estimated to be between 6 to 54%.
The primary aim of this study was to investigate the effects of a single dose preemptive pregabalin on the duration of postoperative analgesia and opioid consumption in patients who had undergone inguinal hernia repair with mesh under spinal anesthesia. Our secondary aim was to determine the effect of pregabalin on chronic pain.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 354 354 0 0
/AnzctrAttachments/368207-local ethical board of study.pdf

Contacts
Principal investigator
Name 55886 0
A/Prof Ali Ahiskalioglu
Address 55886 0
Ataturk university Medical Faculty Department of Anesthesiology and Reanimation 25240 Palandoken/ERZURUM
Country 55886 0
Turkey
Phone 55886 0
+904423448796
Fax 55886 0
Email 55886 0
[email protected]
Contact person for public queries
Name 55887 0
Prof Hulya Aksoy
Address 55887 0
Vaniefendi district, Ethical committee of Ataturk University Medical Faculty ,
Erzurum,Turkey, postal code:25240
Country 55887 0
Turkey
Phone 55887 0
+905074416869
Fax 55887 0
Email 55887 0
[email protected]
Contact person for scientific queries
Name 55888 0
Dr Elif Oral Ahiskalioglu
Address 55888 0
ERzurum Regional Training Hospital Department of Anesthesiology and Reanimation 25070 Palandoken/ERZURUM
Country 55888 0
Turkey
Phone 55888 0
+905059259632
Fax 55888 0
Email 55888 0
[email protected]

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