Ketamine Versus Morphine Change Pain Profile

Does Low-Dose Ketamine Infusion or Intravenous Morphine Infusion During Abdominoplasty Change Postoperative Pain Profile? : A Double-Blind, Randomized, Controlled Clinical Trial

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 Overview

• Status: Completed
• Conditions: Acute Pain
• Intervention / Treatment: Drug: Ketamine; Drug: Morphine

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 Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza
    • Cairo, Giza, Egypt, 1234
      • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
dose of fentanyl	Amount of fentanyl needed intraoperative and postoperative after extubation, and every hour postoperative for four hours.	4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain assessment: VAS (Visual analogue scale)	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 .	4 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient sedation (Ramsey Scale for assessment of patient sedation)	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	4 hours

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: hassan Ali, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): January 20, 2020

Study Registration Dates

• First Submitted: September 6, 2018
• First Submitted That Met QC Criteria: September 7, 2018
• First Posted (Actual): September 10, 2018

Study Record Updates

• Last Update Posted (Actual): June 29, 2020
• Last Update Submitted That Met QC Criteria: June 26, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Opioid; Narcotics; Ketamine; Morphine
• Other Study ID Numbers: wahdan kteamine

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No