Adding Ketamine to Low Dose Bupivacaine in Saddle Block for Perianal Surgery
Primary Purpose
Perianal Fistula, Hemorrhoids
Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Ketamine
bupivacaine
Sponsored by
About this trial
This is an interventional supportive care trial for Perianal Fistula focused on measuring Perianal fistula, Hemorrhoids
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
The ketamine group
The control group
Arm Description
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
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.
Outcomes
Primary Outcome Measures
- Duration of saddle block
(time from intrathecal injection to the time of first complain of pain, first request for analgesia, or a reported NRS >4)
Secondary Outcome Measures
Evaluation of the need of supplemental analgesia
time of 1st dose
Full Information
NCT ID
NCT03264430
First Posted
May 29, 2017
Last Updated
January 13, 2018
Sponsor
Esam Eldin Mohamed Abdalla
1. Study Identification
Unique Protocol Identification Number
NCT03264430
Brief Title
Adding Ketamine to Low Dose Bupivacaine in Saddle Block for Perianal Surgery
Official Title
Adding Ketamine to Low Dose Bupivacaine in Saddle Block for Perianal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
October 31, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Esam Eldin Mohamed Abdalla
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perianal Fistula, Hemorrhoids
Keywords
Perianal fistula, Hemorrhoids
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The ketamine group
Arm Type
Active Comparator
Arm Description
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
Arm Title
The control group
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
ketalar
Intervention Description
an antagonist of the NMDA receptor
Intervention Type
Drug
Intervention Name(s)
bupivacaine
Other Intervention Name(s)
marcaine 0.5 %
Intervention Description
local anaesthetic
Primary Outcome Measure Information:
Title
- Duration of saddle block
Description
(time from intrathecal injection to the time of first complain of pain, first request for analgesia, or a reported NRS >4)
Time Frame
24 hours post-operative
Secondary Outcome Measure Information:
Title
Evaluation of the need of supplemental analgesia
Description
time of 1st dose
Time Frame
24 hours post-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
12. IPD Sharing Statement
Plan to Share IPD
No
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Adding Ketamine to Low Dose Bupivacaine in Saddle Block for Perianal Surgery
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