Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intravenous Ketamine and Postoperative Pain Following Cesarean Section.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03018301
Recruitment Status : Unknown
Verified January 2017 by Abdelrady S Ibrahim, MD, Assiut University.
Recruitment status was:  Recruiting
First Posted : January 12, 2017
Last Update Posted : January 12, 2017
Sponsor:
Information provided by (Responsible Party):
Abdelrady S Ibrahim, MD, Assiut University

Brief Summary:
The purpose of this study is to investigate the analgesic effect of low-dose intravenous ketamine in pregnant mothers undergoing cesarean section under Bupivacaine spinal anesthesia.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Ketamine Other: Normal saline Phase 2

Detailed Description:
  • No premedication will be given, and patients will be monitored by electrocardiogram, non-invasive arterial blood pressure, and pulse oximetry when they entered the operating room.
  • 18 gauge IV cannula will be inserted and all patients will be preloaded with 10 ml/kg of lactate ringer over 20 min period.
  • All participants will have spinal anesthesia using bupivacaine. The dose of the drug, as well as the method of injection will be identical for all individuals; 10 mg (2 cc 0.5%), in the L4-L5 space using needle 25 G, midline, with the patient in a sitting position.
  • After administering bupivacaine, and prior to surgery the height of the sensory block will be assessed bilaterally (complete loss of sensation to ice) in a ascending fashion starting from T12 dermatome.
  • Once adequate anesthesia to at least T6 dermatome will be achieved, the operation will be allowed to begin. When systolic blood pressure decrease to < 90 mmHg, or 30% of the pre-anesthetic blood pressure, it will be corrected by administering 5 mg ephedrine.
  • Patients will be asked to report any intraoperative pain using visual pain score(VPS)of 0(no pain) 10(worst pain).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Single Intravenous Ketamine Dose on Postoperative Pain Following Cesarean Section Under Spinal Anesthesia: A Randomized Control Clinical Trial.
Study Start Date : January 2017
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section
Drug Information available for: Ketamine

Arm Intervention/treatment
Active Comparator: Ketamine group
will receive 0.25 mg/kg intravenous ketamine diluted with normal saline to 20 ml delivered over 10 minutes.
Drug: Ketamine
will receive 0.25 mg/kg intravenous ketamine diluted with normal saline to 20 ml delivered over 10 minutes.
Other Name: Ketalar

Placebo Comparator: Control group
will receive intravenous 20 ml of normal saline, delivered over 10 minutes.
Other: Normal saline
will receive intravenous 20 ml of normal saline, delivered over 10 minutes.




Primary Outcome Measures :
  1. • Number of Subjects Requiring Supplemental Analgesia [ Time Frame: 24 hours postoperative ]

Secondary Outcome Measures :
  1. Cumulative morphine/paracetamol [ Time Frame: 24 hours postoperative ]
  2. Number of subjects reporting nausea, vomiting [ Time Frame: 24 hours postoperative ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Eligible women ASA class 1 and 2, are at term (≥37 week gestation), Scheduled for elective cesarean section whose anesthetic plan is for spinal anesthesia with Bupivacaine and intravenous pethidine and paracetamol for post operative analgesia.

Exclusion Criteria:

  • • Body mass index ≥40 kg/m2,

    • Known allergy to any of the study medications,
    • Contraindication to the spinal anesthesia,
    • History of substance abuse,
    • History of hallucinations,
    • Chronic opioid therapy,
    • Chronic pain.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03018301


Contacts
Layout table for location contacts
Contact: Abdelrady S Ibrahim, MD 00201026249924 aradys2004@gmail.com
Contact: Hamdy A Yousef, MD

Locations
Layout table for location information
Egypt
Assiut university faculty of medicine Recruiting
Assiut, Egypt
Contact: Abdelrady S Ibrahim, MD    00201026249924    aradys2004@gmail.com   
Sponsors and Collaborators
Assiut University
Investigators
Layout table for investigator information
Study Chair: Israa M Sayed Assiut University
Publications:
Layout table for additonal information
Responsible Party: Abdelrady S Ibrahim, MD, Assistant professor of anesthesia and ICU, Assiut University
ClinicalTrials.gov Identifier: NCT03018301    
Other Study ID Numbers: IRB0000871238
First Posted: January 12, 2017    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action