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Completed

NCT Number: NCT04700592

A Comparison of Gabapentin and Ketamine in Acute and Chronic Pain After Inguinal Hernia Repair

Patients were randomized into two groups: Group Gabapentine ( G group) received 600 mg of Gabapentin (two tablets) two hours prior to surgery and saline solution before induction of spinal anesthesia and group Ketamine ( K group) received two placebo tablets and an injection of ketamine at a dosage of 0.15 mg/Kg before induction of spinal anesthesia.. During the surgery, blood pressure and heart rate were monitored. Postoperative analgesia was provided by a PCA morphine. Acute postoperative pain was assessed by a visual analog scale. The incidence of postoperative neuropathic pain was detected by the DN4 questionnaire after one and three months of surgery.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mechaal Benali

Nabeul, 8000, Tunisia

About this study

the investigators includes patients aged at least 18 classified as ASA I and II. Patients with significant cardiovascular or central nervous system disease, as well as those with renal or liver failure and those who could not operate the PCA device were not eligible for our study.

Exclusion criteria

were patients that had incidents during the surgery such as: an allergic reaction, local anesthetic systemic toxicity or a surgical incident.

Patients were randomized into two groups: Group Gabapentine ( G group) received 600 mg of Gabapentin (two tablets) two hours prior to surgery and saline solution before induction of spinal anesthesia and group Ketamine ( K group) received two placebo tablets and an injection of ketamine at a dosage of 0.15 mg/Kg before induction of spinal anesthesia.

Upon arrival in the operating room, patients were monitored using mean blood pressure, heart rate and peripheral oxygen saturation monitors.

The surgery was performed under spinal anesthesia. Each patient received 10 mg of hyperbaric bupivacaine mixed with 5 µ of sufentanil.

Immediately after the intervention, the patients were transferred to the post anesthesia care unit (PACU) where analgesia was arranged through morphine titration.

After the motor block is lifted, patients were transferred to surgery department where they were connected to a PCA device that provided 1 mg IV bolus injection of morphine at a lockout interval of 7 minutes and with a maximum four-hour limit of 0.5 mg/Kg.

During the hospital stay, acute post-operative pain assessed through the visual analog scale (VAS) at rest and at motion, every 15 minutes in the PACU and then at H2, H6, H12 and H24 postoperative.

The morphine consumption was noted as well as its first demand. Sedation was assessed using the Ramsay score. The occurrence of adverse effects such as nausea and vomiting, dizziness, diarrhea, hallucination and pruritus was also noted.

The first night sleep quality was evaluated through the Spiegel score. After hospital discharge, patients were contacted at one month and three months. The incidence of post-operative neuropathic pain was detected by the DN4 questionnaire. The effect the pain had on their daily activities was also judged.

Statistical analysis:

According to available data (30% occurrence of post-operative chronic pain after inguinal hernia repair (2)), to decrease by 25% this number with a power of 80%, 28 patients were needed in each group.

Statistical analysis was performed with SPSS in its 20 version. Results were expressed as mean, standard variation or median. χ2 test, fisher's exact test and Mann-Whitney test were performed. A P value of < 0.05 was considered as statistically significant.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA I and II
  • Inguinal Hernia Repair in non emergent conditions

Exclusion criteria

  • Patients with significant cardiovascular central nervous system disease, renal or liver failure could not operate the PCA device

Treatment and study plan

Gabapentin versus Ketamine

Other

A Comparison of Gabapentin and Ketamine in Acute and Chronic Pain

Other names: acute and Chronic Pain

Primary outcomes

  1. postoperative neuropathic pain

    Time frame: three months of surgery

    the DN4 questionnaire

Secondary outcomes

  1. acute pain postoperative

    Time frame: At twenty-four hour postoperative

    the visual analogue scales (VAS) at rest and at motion

  2. Consumption of morphine

    Time frame: At 24 hour postoperative

    measuring consumption by PCA (PATIENT CONTROLLED ANALGESIA)

Sponsors and collaborators

Lead sponsor

University Tunis El Manar

Other

Registry information

Official study title

A Comparison of Gabapentin and Ketamine in Acute and Chronic Pain After Inguinal Hernia Repair: a Prospective Randomized Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 8, 2021
Registry last updated
Jun 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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