ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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

Condition category

Condition code

Anaesthesiology

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]

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]

Postoperative pain. Postoperative analgesia was evaluated during resting and actively moving, using Visual Analogue Scale (VAS).

Timepoint [1]

first 24 hours after operation

Primary outcome [2]

duration of postoperative analgesia. Assessed with medical records.

Timepoint [2]

first 24 hours after operation

Primary outcome [3]

opioid consumption. Assessed with medical records

Timepoint [3]

first 24 hours after operation

Secondary outcome [1]

Our secondary aim was to determine the effect of pregabalin on chronic pain. Pain was assessed by numerical rating scale.

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Turkey

State/province [1]

Erzurum

Funding & Sponsors

Funding source category [1]

University

Name [1]

Ataturk University

Address [1]

Department of Anaesthesiology and Reanimation,
Faculty of Medicine, Ataturk University, Erzurum, Turkey
Postal code: 25240

Country [1]

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]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethical committee of Ataturk University Medical Faculty

Ethics committee address [1]

Vaniefendi district, Ataturk University Medical Faculty , Erzurum,Turkey
postal code:25240

Ethics committee country [1]

Turkey

Date submitted for ethics approval [1]

01/04/2014

Approval date [1]

24/04/2014

Ethics approval number [1]

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]

/AnzctrAttachments/368207-local ethical board of study.pdf

Contacts

Principal investigator

Name

A/Prof Ali Ahiskalioglu

Address

Ataturk university Medical Faculty Department of Anesthesiology and Reanimation 25240 Palandoken/ERZURUM

Country

Turkey

Phone

+904423448796

Fax

aliahiskalioglu@hotmail.com

Contact person for public queries

Name

Hulya Aksoy

Address

Vaniefendi district, Ethical committee of Ataturk University Medical Faculty ,
Erzurum,Turkey, postal code:25240

Country

Turkey

Phone

+905074416869

Fax

aksoyhulya@yahoo.com

Contact person for scientific queries

Name

Elif Oral Ahiskalioglu

Address

ERzurum Regional Training Hospital Department of Anesthesiology and Reanimation 25070 Palandoken/ERZURUM

Country

Turkey

Phone

+905059259632

Fax

drelforl@hotmail.com

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically