Ketamine Versus Morphine Change Pain Profile

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT03664622
Collaborator
(none)
160
1
2
16.2
9.9

Study Details

Study Description

Brief Summary

The aim of this study is to evaluate the efficacy of intravenous low dose ketamine infusion versus morphine infusion analgesia for pain reduction in Abdominoplasty surgery

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

Abdominoplasty is considered one of the most commonly performed cosmetic procedures. According to statistics from the International Society of Aesthetic Plastic Surgery, a total of 758,590 abdominoplasties were performed in the world in 2016. This is an increase of 72.95% in comparison with 2011, making it the fourth most common cosmetic procedure. Given the increasing number of abdominoplasties performed, the importance of understanding the possible complications and morbidity associated with the procedure is critical. One of these complications is the postoperative pain. With adequate postoperative pain control, the patients met discharge criteria sooner and this helps in shortening the hospital stay, better overall patient satisfaction, and decreased hospital costs. Therefore, the severity of this problem and the all drug agent used to prevent and treat postoperative pain best interest to be aware in the anesthesiologists. Traditionally, analgesia for abdominal wall surgery is provided either by systemic drugs such as opioids, nonsteroidal anti-inflammatories, alpha 2 agonists and paracetamol or by epidural analgesia. However, Opioids, such as morphine or fentanyl, remain the mainstay of postoperative analgesic regimens for patients after abdominal wall surgery. The pain is not always fully relieved by such agents, and often patients develop tolerance to them. The ever-increasing doses of opioids are clearly not without their adverse effects. (5) For this Alternative approaches, which reduce the requirement for strong opioids post-operative, are required. Recently, interest has focused on the use of N-methyl-D-aspartate (NMDA) receptor antagonists for the management of postoperative pain. Ketamine exerts its main analgesic effect by antagonism of NMDA receptors that not only abolishes peripheral afferent noxious stimulation, but it may also prevent central sensitization of nociceptors as shown in animal studies with the excellent analgesic property even in subanesthetic doses. (6) Various recently published studies have talked about the analgesic effect of low-dose ketamine (7,8) however, all of this study are relatively short procedure time, reduced surgical stimulation and small sample size. The aim of this study is to evaluate the efficacy of intravenous low dose ketamine infusion versus morphine infusion analgesia for pain reduction in Abdominoplasty surgery

Study Design

Study Type:
Interventional
Actual Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
ketamine versus morphineketamine versus morphine
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Does Low-Dose Ketamine Infusion or Intravenous Morphine Infusion During Abdominoplasty Change Postoperative Pain Profile? : A Double-Blind, Randomized, Controlled Clinical Trial
Actual Study Start Date :
Sep 15, 2018
Actual Primary Completion Date :
Dec 31, 2019
Actual Study Completion Date :
Jan 20, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: group K

patients with a ketamine infusion intraoperative

Drug: Ketamine
Ketamine group to whom intravenous ketamine was administered in a loading dose of 0.15 mg/kg over 5 min, 10 minutes pre incision, followed-by an infusion at 2 micg/kg/min until the end of surgery.
Other Names:
  • Ketamine infusion
  • Experimental: group M

    patients with a Morphine infusion intraoperative

    Drug: Morphine
    a loading dose of 0.1 mg/kg over 20 min intravenously, 10 minutes pre incision, then infused with morphine an infusion rate of 5 - 40 microgram/kg/hour till the end of surgery.
    Other Names:
  • Morphine infusion
  • Outcome Measures

    Primary Outcome Measures

    1. dose of fentanyl [4 hours]

      Amount of fentanyl needed intraoperative and postoperative after extubation, and every hour postoperative for four hours.

    Secondary Outcome Measures

    1. pain assessment: VAS (Visual analogue scale) [4 hours]

      Visual analogue scale for pain assessment.( VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom,pain,health) orientated from the left (worst) to the right (best). In some studies,horizontal scales are orientated from right to left ,and many investigators use vertical VAS.The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom,pain,health) orientated from the left (worst) to the right (best). In some studies,horizontal scales are orientated from right to left .

    Other Outcome Measures

    1. patient sedation (Ramsey Scale for assessment of patient sedation) [4 hours]

      Anxious agitated and restless= 1 point Cooperative, oriented and tranquil= 2 points Responding only to verbal commands= 3 points Brisk response to light glabella tap or loud auditory stimulus= 4points Sluggish response to light glabella tap or loud auditory response= 5 points No response to light glabella tap or loud auditory response= 6 points

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • ASA physical status I or II

    • patients aged between 18-50 years old. -

    Exclusion Criteria:
    • those who refused to participate

    • ASA physical status III, IV, patients younger than 18 years or older than 50 years old

    • super morbid obesity with BMI 50, history of epilepsy

    • patients having a history of parenteral or oral analgesics within the last 24 hours before

    • initiation of operation

    • those having an allergy to study agents.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cairo University Cairo Giza Egypt 1234

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Principal Investigator: hassan Ali, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hassan Mohamed Ali, associate professor, Cairo University
    ClinicalTrials.gov Identifier:
    NCT03664622
    Other Study ID Numbers:
    • wahdan kteamine
    First Posted:
    Sep 10, 2018
    Last Update Posted:
    Jun 29, 2020
    Last Verified:
    Jun 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 29, 2020