Neostigmine and Dexamethasone in Adductor Canal Block
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Dexamethasone
neostigmine
NaCl solutions
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
Eligibility Criteria
Inclusion Criteria:
- patients undergoing knee arthroscopy surgery.
- Age between 18 years and 65 years.
- Both sexes
- ASA I & ASA II
Exclusion Criteria:
- Patients' refusal
- Allergy to any drug that will be used in the study
- Psychological or mental disorders.
- Disturbance of Conscious level.
- Uncooperative patients
- Coagulopathy
- Contraindications to spinal anaesthesia (e.g.: severe mitral stenosis)
Sites / Locations
- Kasr Alainy hospitals
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Group C
Group D
Group N
Arm Description
The patients in this group will be administered 2 ml isotonic saline + 20 ml bupivacaine 0.50 % in the adductor canal block (control group).
The patients in this group will be administered 8 mg dexamethasone (2 ml) (23) as adjuvant to 20 ml bupivacaine 0.50 % in the adductor canal block.
The patients in this group will be administered 500 mcg neostigmine (1 ml) + 1 ml isotonic saline (22) as adjuvant to 20 ml bupivacaine 0.50 % in the adductor canal block.
Outcomes
Primary Outcome Measures
first rescue analgesia time
Time (in hours) of first rescue analgesia (morphine) requirement for each group in the first 24 hours following the adductor canal block
Secondary Outcome Measures
morphine consumption
Total amount of morphine consumed in the first 24 hours following the AC
Visual analogue scale
VAS score at times 0-30 minutes, 1, 2, 4, 8, 12, 18 and 24 hours postoperatively. As visual analouge scale (VAS) is a scale from 0 to 10 where "0" means no pain and "10" means the most severe pain.
sensory block
Duration of sensory block at times 0-30 minutes, 1, 2, 4, 8, 12, 18 and 24 hours postoperatively
Presence of Nausea and vomiting
through a question answered by yes or no to identify the presence of nausea and vomiting
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04565301
Brief Title
Neostigmine and Dexamethasone in Adductor Canal Block
Official Title
A Comparative Study Between Neostigmine and Dexamethasone as an Adjuvant to Bupivacaine in Adductor Canal Block After Knee Arthroscopy Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
June 20, 2021 (Actual)
Primary Completion Date
July 27, 2022 (Actual)
Study Completion Date
July 27, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To compare between the efficacy of neostigmine and dexamethasone as an adjuvant to bupivacaine in adductor canal block after knee arthroscopy surgery.
Detailed Description
90 participants in this study will be randomized into three groups based on computer generated numbers using computerized generated random tables. The patients enrolled in the study will be transferred to the operation room and monitored all through the surgical procedure using pulse oximeter, non-invasive blood pressure and ECG.
To perform spinal anesthesia ,the patient will be positioned in the sitting position then sterilization of the back using betadine solution 5% will be done then the iliac crest will be identified and the opposite intervertebral space(L4-L5) will be marked then 5 ml of lidocaine 2% will be infiltrated in the skin and subcutaneous tissue then a spinal needle (25G) will be introduced to the intrathecal space and after ensuring that clear cere¬brospinal fluid will be in free flow injection of 15-20mg of bupivacaine 0.5% and 25mcg of fentanyl will be administrated then the patient will be positioned in the supine position.
If hypotension, (decrease in the mean arterial blood pressure of more than 20%from base line) occurs, 9mg intravenous ephedrine will be given with 200ml bolus crystalloids. If bradycardia (heart rate below 50beat / minute) occurs, 0.5mg intravenous atropine will be given. After the surgical procedure the patients will be randomly allocated using computerized generated random tables in to three equal groups and the random numbers will be concealed in closed opaque envelopes which will be kept by the senior anesthesia staff, the three groups are:
Group neostigmine: The patients in this group will be administered 500 mcg neostigmine (1 ml) + 1 ml isotonic saline (22) as adjuvant to 20 ml bupivacaine 0.50 % in the adductor canal block.
Group dexamethasone: The patients in this group will be administered 8 mg dexamethasone (2 ml) (23) as adjuvant to 20 ml bupivacaine 0.50 % in the adductor canal block.
Group control: The patients in this group will be administered 2 ml isotonic saline + 20 ml bupivacaine 0.50 % in the adductor canal block (control group).
With the patient in the supine position, the procedural needle (Braun Stimuplex Ultra Insuflated Echogenic Needle 22G) will be inserted in plane from the anteromedial side at the mid thigh level. It will be advanced through the sartorius muscle and fascia under ultrasound guidance, using a Siemens Acuson X300 ultrasound equipped with a linear transducer after sterilization of the skin with betadine solution 5%, and the adductor canal, with the superficial femoral artery and vein within, will be identified. Once the needle tip will be located in the adductor canal, the anaesthetic solution will be injected anterior to the artery and deep into the sartorius muscle (24) then patient will be transferred to the PACU then to the ward.
Postoperative
Postoperative pain will be assessed by visual analog scale (VAS)
A fixed dose of intravenous paracetamol 1 gram will be given every 6 hours to all patients in the three groups starting from 1 hour after the ACB.
Postoperative pain assessment through VAS will be according to the scale as follow:
Pain level 0: no pain
Pain level1-3: mild pain
Pain level 4-6: moderate pain
Pain level 7-10: severe pain
Postoperative pain will be managed as follow:
Mild pain will be treated with ketolac 30mg IV.
Moderate pain will be treated with ketolac 30mg IV + morphine 0.07mg/kg IV.
Severe pain will be treated with ketolac 30mg IV & morphine 0.1mg/kg IV. Then patient will be reassessed and recorded as mentioned above and the specific treatment will be repeated after 8 hours from the initial dose according to VAS.
Opioids complications such as respiratory depression will be recorded and managed supportively by oxygen mask, controlled airway and if persistent or severe hypoventilation occurs positive pressure ventilation may be needed, nausea and vomiting will be treated with ondansterone (4mg IV).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group C
Arm Type
Placebo Comparator
Arm Description
The patients in this group will be administered 2 ml isotonic saline + 20 ml bupivacaine 0.50 % in the adductor canal block (control group).
Arm Title
Group D
Arm Type
Active Comparator
Arm Description
The patients in this group will be administered 8 mg dexamethasone (2 ml) (23) as adjuvant to 20 ml bupivacaine 0.50 % in the adductor canal block.
Arm Title
Group N
Arm Type
Active Comparator
Arm Description
The patients in this group will be administered 500 mcg neostigmine (1 ml) + 1 ml isotonic saline (22) as adjuvant to 20 ml bupivacaine 0.50 % in the adductor canal block.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Decadron
Intervention Description
adductor canal block
Intervention Type
Drug
Intervention Name(s)
neostigmine
Other Intervention Name(s)
prostigmin
Intervention Description
adductor canal block
Intervention Type
Other
Intervention Name(s)
NaCl solutions
Other Intervention Name(s)
normal saline
Intervention Description
adductor canal block
Primary Outcome Measure Information:
Title
first rescue analgesia time
Description
Time (in hours) of first rescue analgesia (morphine) requirement for each group in the first 24 hours following the adductor canal block
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
morphine consumption
Description
Total amount of morphine consumed in the first 24 hours following the AC
Time Frame
24 hours
Title
Visual analogue scale
Description
VAS score at times 0-30 minutes, 1, 2, 4, 8, 12, 18 and 24 hours postoperatively. As visual analouge scale (VAS) is a scale from 0 to 10 where "0" means no pain and "10" means the most severe pain.
Time Frame
up to 24 hours
Title
sensory block
Description
Duration of sensory block at times 0-30 minutes, 1, 2, 4, 8, 12, 18 and 24 hours postoperatively
Time Frame
up to 24 hours
Title
Presence of Nausea and vomiting
Description
through a question answered by yes or no to identify the presence of nausea and vomiting
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients undergoing knee arthroscopy surgery.
Age between 18 years and 65 years.
Both sexes
ASA I & ASA II
Exclusion Criteria:
Patients' refusal
Allergy to any drug that will be used in the study
Psychological or mental disorders.
Disturbance of Conscious level.
Uncooperative patients
Coagulopathy
Contraindications to spinal anaesthesia (e.g.: severe mitral stenosis)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heba Omar
Organizational Affiliation
associate professor of anesthesia and surgical ICU, faculty of medicine, Cairo university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alainy hospitals
City
Cairo
ZIP/Postal Code
11562
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Neostigmine and Dexamethasone in Adductor Canal Block
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