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

Primary Purpose

Chronic Pain Following Surgical Procedure for Cancer

Status
Completed
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
Gabapentin versus Ketamine
Sponsored by
University Tunis El Manar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain Following Surgical Procedure for Cancer focused on measuring post operative chronic pain, gabapentin, ketamin, Inguinal Hernia Repair

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mechaal Benali

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Gabapentin group

ketamine group

Arm Description

group which receives 600 mg of Gabapentin (two tablets) one hour prior to surgery

group which receives an injection of ketamine at a dosage of 0.15 mg/Kg before surgery incision

Outcomes

Primary Outcome Measures

postoperative neuropathic pain
the DN4 questionnaire

Secondary Outcome Measures

acute pain postoperative
the visual analogue scales (VAS) at rest and at motion
Consumption of morphine
measuring consumption by PCA (PATIENT CONTROLLED ANALGESIA)

Full Information

First Posted
January 2, 2021
Last Updated
May 30, 2021
Sponsor
University Tunis El Manar
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1. Study Identification

Unique Protocol Identification Number
NCT04700592
Brief Title
A Comparison of Gabapentin and Ketamine in Acute and Chronic Pain After Inguinal Hernia Repair
Official Title
A Comparison of Gabapentin and Ketamine in Acute and Chronic Pain After Inguinal Hernia Repair: a Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 2, 2020 (Actual)
Primary Completion Date
February 2, 2021 (Actual)
Study Completion Date
February 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Tunis El Manar

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain Following Surgical Procedure for Cancer
Keywords
post operative chronic pain, gabapentin, ketamin, Inguinal Hernia Repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gabapentin group
Arm Type
Experimental
Arm Description
group which receives 600 mg of Gabapentin (two tablets) one hour prior to surgery
Arm Title
ketamine group
Arm Type
Experimental
Arm Description
group which receives an injection of ketamine at a dosage of 0.15 mg/Kg before surgery incision
Intervention Type
Other
Intervention Name(s)
Gabapentin versus Ketamine
Other Intervention Name(s)
acute and Chronic Pain
Intervention Description
A Comparison of Gabapentin and Ketamine in Acute and Chronic Pain
Primary Outcome Measure Information:
Title
postoperative neuropathic pain
Description
the DN4 questionnaire
Time Frame
three months of surgery
Secondary Outcome Measure Information:
Title
acute pain postoperative
Description
the visual analogue scales (VAS) at rest and at motion
Time Frame
At twenty-four hour postoperative
Title
Consumption of morphine
Description
measuring consumption by PCA (PATIENT CONTROLLED ANALGESIA)
Time Frame
At 24 hour postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mechaal benali, PROFESSOR
Organizational Affiliation
university manar Tunis tunisia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mechaal Benali
City
Nabeul
ZIP/Postal Code
8000
Country
Tunisia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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