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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 : Unknown
Verified January 2018 by Esam Eldin Mohamed Abdalla, Assiut University.
Recruitment status was:  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

Tracking Information
First Submitted Date  ICMJE May 29, 2017
First Posted Date  ICMJE August 29, 2017
Last Update Posted Date January 17, 2018
Actual Study Start Date  ICMJE January 1, 2017
Estimated Primary Completion Date October 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2017)
- 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2017)
Evaluation of the need of supplemental analgesia [ Time Frame: 24 hours post-operative ]
time of 1st dose
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adding Ketamine to Low Dose Bupivacaine in Saddle Block for Perianal Surgery
Official Title  ICMJE Adding Ketamine to Low Dose Bupivacaine in Saddle Block for Perianal Surgery
Brief Summary Evaluation of the anesthetic quality and analgesic efficacy of adding ketamine to intrathecal bupivavaine in selective saddle block for perianal surgery.
Detailed Description

This study will be carried out in Assiut University Hospitals, General Surgery Operative room and Post Anaesthesia Care Unit (PACU).

This study will include 60 adult participants (ASA I&II) scheduled for minor perianal surgery (perianal fistula, haemorrhoids or both). After approval of ethics committee and written informed consent will be obtained from the participants.

Investigators will exclude participants with classic contraindications to spinal block, pre-existing systemic disease (such as cardiovascular, respiratory or renal diseases), coagulopathy and participants taking any medications that could influence the haemodynamic response.

The selected participants will be divide into two groups (30 participants for each group), ketamine group and placebo (control) 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. The control 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.

Anaesthetic technique

participants will receive oral medication 60 minutes preoperatively with 0.5 mg/kg of midazolam.

After arrival at the OR, an intravenous (IV) 18-20G catheter was placed and infusion of 20 ml/kg NaCl 0.9% will start. Standard monitoring electrocardiogram (ECG), heart rate (HR), oxygen saturation (SpO2), and non-invasive blood pressure (BP) will be started.

Dural puncture was made in the sitting position with a 25 gauge spinal needle using a median approach. After aspiration, the dose of anaesthetic as indicated in the envelope was injected over two minutes. The time of Dural puncture was used as the Primary starting point of assessment. The medications injection will be over 10 s with no barbotage and the needle orifice cephaled. After intrathecal injection, participants will kept sitting for 10 minutes, after that the patient will lie in the lithotomy position and received 100% O2 (4 L/min) with face mask.

Ten minutes after the Dural puncture, participants will asked to lie down and the level of sensory block will tested with an alcohol swab. Motor block was tested by modified Bromage scale (0 = no motor block, 1 = able to flex ankle and bend knees, 2 = able to flex ankle, and 3 = full motor block) [21], and surgery in the supine position will allow to started. In case of failed block, general anaesthesia will be induced.

Non-invasive BP taken every 5 minutes and HR were assessed in the OR. Reduction of mean BP (MAP) and HR >20% from baseline was judged clinically significant. A decrease in systolic BP below 90 mmHg will be treated with 5 mg of IV ephedrine, HR<45 beats per minute (bpm) will be treated with 0.5 mg of IV atropine.

Patient assessment:

  • Demographics (age, gender, type of surgery); duration of anesthesia (from the moment of dural puncture until patient left the OR) and surgery in minutes.
  • Rate of success (failed block, number of attempts made, ease of performance scale 1-3, where 3 = easy to perform, 2 =moderate, 1 = difficult, multiple attempts needed);
  • level of sensory (dermatomes) and motor (Bromage scale) block10 minutes after dural puncture, at the end of surgery, and in the ward every 30 minutes until resolution of the block and afterwards at 6, 9, 12, 18 and 24 hours postoperatively;
  • MAP and HR every 5 minutes in the OR, then every 4 hours for postoperative 24 hours;
  • Complications during performance of anesthesia: paresthesias, toxic reactions,
  • Level of postoperative pain on a written VAS scale (0-10 mm).
  • Time of 1st analgesic request, and number of requests for each patient will be recorded in the 1st 24 hours.
  • Consumption of rescue analgesia; if VAS is ≥ 5 in the form of 30 mg intramuscular (IM) repeated twice as patient satisfaction and 0.1mg of morphine for up stocking of pain
  • Postoperative complications:

    - Urinary retention (0-2 scale, where 0 = normal urination, 1 = difficult spontaneous urination, and 2 = unable to urinate, catheterization needed.

  • Postoperative nausea and vomiting (PONV; 0-3 scale, where 0 = no nausea, 1 = slight nausea, 2 = nausea and single vomiting, and 3 = multiple vomiting) [15],
  • Postdural puncture headache (PDPH) at day 1 postoperatively and 10 days later by phone call at home,
  • Transient neurologic symptoms (TNS), backache, itching, allergic reactions, time of postoperative recovery, time to urinate, duration of sensory and motor block, and time to stand and walk unsupported

Statistical analysis

The data will be recorded on and analyzed using SPSS-12. The results will be presented as Mean ±SD or percent of patients. For proportions, Pearson test or Fisher's test will be used. Student's t-test being used for quantitative variables. A p-value of <0.05 will be considered to show statistical significance.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Perianal Fistula
  • Hemorrhoids
Intervention  ICMJE
  • Drug: Ketamine
    an antagonist of the NMDA receptor
    Other Name: ketalar
  • Drug: bupivacaine
    local anaesthetic
    Other Name: marcaine 0.5 %
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: Ketamine
    • Drug: bupivacaine
  • 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.
    Intervention: Drug: bupivacaine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: August 25, 2017)
60
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2018
Estimated Primary Completion Date October 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03264430
Other Study ID Numbers  ICMJE 17100219
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Esam Eldin Mohamed Abdalla, Assiut University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Esam Eldin Mohamed Abdalla
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assiut University
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP