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Adding Ketamine to Low Dose Bupivacaine in Saddle Block for Perianal Surgery

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ClinicalTrials.gov Identifier: NCT03264430
Recruitment Status : Active, not recruiting
First Posted : August 29, 2017
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Esam Eldin Mohamed Abdalla, Assiut University

Brief Summary:
Evaluation of the anesthetic quality and analgesic efficacy of adding ketamine to intrathecal bupivavaine in selective saddle block for perianal surgery.

Condition or disease Intervention/treatment Phase
Perianal Fistula Hemorrhoids Drug: Ketamine Drug: bupivacaine Early Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Adding Ketamine to Low Dose Bupivacaine in Saddle Block for Perianal Surgery
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas Hemorrhoids
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: The ketamine group
The ketamine group will receive intrathecal bupivacaine (7.5 mg) in 1.5 ml (Marcaine, Astra Zeneca, France, 0.5%) and ketamine (25mg) in 0.5 ml (Ketam, EIPICO, Egypt, 50 mg/mL),. Total volume is 2 ml will injected
Drug: Ketamine
an antagonist of the NMDA receptor
Other Name: ketalar
Drug: bupivacaine
local anaesthetic
Other Name: marcaine 0.5 %
Placebo Comparator: The control group
group will receive only intrathecal bupivacaine (7.5 mg) in 1.5 ml plus 0.5ml normal saline to achieve total volume of 2 ml.
Drug: bupivacaine
local anaesthetic
Other Name: marcaine 0.5 %



Primary Outcome Measures :
  1. - Duration of saddle block [ Time Frame: 24 hours post-operative ]
    (time from intrathecal injection to the time of first complain of pain, first request for analgesia, or a reported NRS >4)


Secondary Outcome Measures :
  1. Evaluation of the need of supplemental analgesia [ Time Frame: 24 hours post-operative ]
    time of 1st dose



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects will be included in the study only if they meet all of the following criteria:
  • Patients scheduled for perianal surgeries.
  • Age 18-55 years.
  • ASA physical status I-II.

Exclusion Criteria:

  • Subjects will be excluded from the study for any of the following reasons:
  • Patient refusal
  • Any contraindication of regional anaesthesia
  • Failed Technique

Responsible Party: Esam Eldin Mohamed Abdalla, Clinical Professor, Assiut University
ClinicalTrials.gov Identifier: NCT03264430     History of Changes
Other Study ID Numbers: 17100219
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Esam Eldin Mohamed Abdalla, Assiut University:
Perianal fistula
Hemorrhoids

Additional relevant MeSH terms:
Fistula
Hemorrhoids
Pathological Conditions, Anatomical
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Bupivacaine
Ketamine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action