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

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ClinicalTrials.gov Identifier: NCT04700592
Recruitment Status : Completed
First Posted : January 8, 2021
Last Update Posted : June 3, 2021
Sponsor:
Information provided by (Responsible Party):
Mechaal Benali, University Tunis El Manar

Tracking Information
First Submitted Date  ICMJE January 2, 2021
First Posted Date  ICMJE January 8, 2021
Last Update Posted Date June 3, 2021
Actual Study Start Date  ICMJE October 2, 2020
Actual Primary Completion Date February 2, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2021)
postoperative neuropathic pain [ Time Frame: three months of surgery ]
the DN4 questionnaire
Original Primary Outcome Measures  ICMJE
 (submitted: January 6, 2021)
The incidence of postoperative neuropathic pain [ Time Frame: after three months of surgery ]
the DN4 questionnaire
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2021)
  • acute pain postoperative [ Time Frame: At twenty-four hour postoperative ]
    the visual analogue scales (VAS) at rest and at motion
  • Consumption of morphine [ Time Frame: At 24 hour postoperative ]
    measuring consumption by PCA (PATIENT CONTROLLED ANALGESIA)
Original Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2021)
  • acute pain postoperative [ Time Frame: At twenty-four hour postoperative ]
    the visual analogue scales (VAS) are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain at rest and at motion
  • Consumption of morphine [ Time Frame: At 24 hour postoperative ]
    measuring consumption by PCA (PATIENT CONTROLLED ANALGESIA)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison of Gabapentin and Ketamine in Acute and Chronic Pain After Inguinal Hernia Repair
Official Title  ICMJE A Comparison of Gabapentin and Ketamine in Acute and Chronic Pain After Inguinal Hernia Repair: a Prospective Randomized Study
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Chronic Pain Following Surgical Procedure for Cancer
Intervention  ICMJE Other: Gabapentin versus Ketamine
A Comparison of Gabapentin and Ketamine in Acute and Chronic Pain
Other Name: acute and Chronic Pain
Study Arms  ICMJE
  • Experimental: Gabapentin group
    group which receives 600 mg of Gabapentin (two tablets) one hour prior to surgery
    Intervention: Other: Gabapentin versus Ketamine
  • Experimental: ketamine group
    group which receives an injection of ketamine at a dosage of 0.15 mg/Kg before surgery incision
    Intervention: Other: Gabapentin versus Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 6, 2021)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2, 2021
Actual Primary Completion Date February 2, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Tunisia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04700592
Other Study ID Numbers  ICMJE UTEM GABA
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mechaal Benali, University Tunis El Manar
Study Sponsor  ICMJE University Tunis El Manar
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: mechaal benali, PROFESSOR university manar Tunis tunisia
PRS Account University Tunis El Manar
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP