The effects of a single dose preemptive pregabalin on acute and chronic pain after inguinal hernia repair with mesh under spinal anesthesia

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000435583
• Date of registration: 06/05/2015
• Prospective Registration: No
• Primary sponsor: Ataturk University
• 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
• Date of first enrolment: 01/05/2014
• Target sample size: 60
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000435583.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Phase 4

Countries of recruitment

Turkey

Contacts

• Name: Dr Elif Oral Ahiskalioglu

• Name: Prof Hulya Aksoy

Key inclusion & exclusion criteria

Inclusion criteria: 18-65 years female and male
patients undergoing inguinal hernia repair with mesh under spinal anesthesia
ASA I – II
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,

Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Anaesthesiology - Pain management

acute and chronic pain after inguinal hernia repair ;
acute and chronic pain after inguinal hernia repair

Intervention(s)

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.

Primary Outcome(s)

duration of postoperative analgesia. Assessed with medical records.[first 24 hours after operation]

opioid consumption. Assessed with medical records[first 24 hours after operation]

Postoperative pain. Postoperative analgesia was evaluated during resting and actively moving, using Visual Analogue Scale (VAS).[first 24 hours after operation]

Secondary Outcome(s)

Our secondary aim was to determine the effect of pregabalin on chronic pain. Pain was assessed by numerical rating scale.[Numerical Rating Scale scores were assessed 1 months, 3 months and 6 months after operation.]

Secondary ID(s)

None

Source(s) of Monetary Support

Ataturk University

Ethics review

Status: Approved
Approval date:
Contact:

Ethical committee of Ataturk University Medical Faculty