None listed
Conditions
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.
Interventions
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 Pl
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.
Sponsors
Ataturk University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
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,
Outcome results
None listed