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Pain, PostoperativeNCT04565301

Neostigmine and Dexamethasone in Adductor Canal Block

A study testing Dexamethasone, neostigmine and NaCl solutions in people with Pain, Postoperative, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To compare between the efficacy of neostigmine and dexamethasone as an adjuvant to bupivacaine in adductor canal block after knee arthroscopy surgery. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Pain, Postoperative
What is being tested?
Dexamethasone, neostigmine and NaCl solutions
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteEgypt
Study dates
20 Jun 2021to 27 Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients undergoing knee arthroscopy surgery.
  • Age between 18 years and 65 years.
  • Both sexes
  • ASA I \& ASA II

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Kasr Alainy hospitals

    Cairo, 11562

Other trials in Egypt

About this study

Official title: A Comparative Study Between Neostigmine and Dexamethasone as an Adjuvant to Bupivacaine in Adductor Canal Block After Knee Arthroscopy Surgery

To compare between the efficacy of neostigmine and dexamethasone as an adjuvant to bupivacaine in adductor canal block after knee arthroscopy surgery.

Read the 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

  1. Postoperative pain will be assessed by visual analog scale (VAS)
  2. 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.
  3. 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
  1. 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.
  1. 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).
Being tested
Dexamethasone, neostigmine, NaCl solutions
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexamethasoneDrug

    Also called Decadron

    adductor canal block

  • neostigmineDrug

    Also called prostigmin

    adductor canal block

  • NaCl solutionsOther

    Also called normal saline

    adductor canal block

Study groups in NCT04565301
Study groupRoleWhat they receive
Group CPlacebo comparatorThe patients in this group will be administered 2 ml isotonic saline + 20 ml bupivacaine 0.50 % in the adductor canal block (control group).
Receives: Other: NaCl solutions
Group DActive comparatorThe 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.
Receives: Drug: Dexamethasone
Group NActive comparatorThe 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.
Receives: Drug: neostigmine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 24 hours

Secondary outcomes (4)
  1. morphine consumption

    Total amount of morphine consumed in the first 24 hours following the AC

    Measured: 24 hours

  2. 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.

    Measured: up to 24 hours

  3. sensory block

    Duration of sensory block at times 0-30 minutes, 1, 2, 4, 8, 12, 18 and 24 hours postoperatively

    Measured: up to 24 hours

  4. Presence of Nausea and vomiting

    through a question answered by yes or no to identify the presence of nausea and vomiting

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2020
  2. Study start20 Jun 2021
  3. Primary completion27 Jul 2022
  4. Study completion27 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04565301
Sponsor's protocol ID
MS-161-2020
Status last verified
Jul 2022
First submitted
26 Aug 2020
Last updated
29 Jul 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Dexamethasone, neostigmine and NaCl solutions in people with Pain, Postoperative, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

first rescue analgesia time (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022.

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