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Postoperative PainNCT02805920

Comparison Between 3 Solutions of Bupivacaine of Adductor Canal Block for Anterior Cruciate Ligament Reconstruction

A study testing Bupivacaine in people with Postoperative Pain, run by Procare Riaya Hospital at 2 sites in Saudi Arabia.

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

Adductor canal block (ACB) is a new technique gaining acceptance as an alternative analgesic method of femoral nerve block (FNB) following knee surgery. The advantage of ACB is its dominant sensory nerve block effect. It preserves quadriceps muscle strength compared with the FNB. Read more about this study

Who is it for?
Ages 18 to 50 years, men only
Conditions the study is for
Postoperative Pain
What is being tested?
Bupivacaine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
2 sitesSaudi Arabia
Study dates
30 Aug 2016to 30 Jun 2017
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 50 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • American ASA I, II
  • body mass index ≤ 35 kg/m2
  • surgery time ≤ 2 hours

Who cannot join

  • Infection at the side at the procedure site,
  • Patients with diabetes mellitus,
  • Intake of any analgesic during the last 48h,
  • History to local anesthetics allergy

Trial locations and contacts

2 sites in 1 country.

Saudi Arabia2 sites
  • Procare Riaya Hospital

    Khobar, Eastern Province, 31952

  • Procare

    Khobar

Other trials in Saudi Arabia

About this study

Official title: Adductor Canal Block for Postoperative Analgesia After Anterior Cruciate Ligament Reconstruction: Comparison Between 3 Bupivacaine Volumes and Doses

Adductor canal block (ACB) is a new technique gaining acceptance as an alternative analgesic method of femoral nerve block (FNB) following knee surgery. The advantage of ACB is its dominant sensory nerve block effect. It preserves quadriceps muscle strength compared with the FNB. This will serve as potential gain for early rehabilitation and thereby functional outcome. Adequate direct injection of local anesthetic into the canal will block four nerves: the saphenous nerve, the nerve to the vastus medialis, the medial femoral cutaneous nerve, and the terminal end of the posterior division of the obturator nerve. Anterior cruciate ligament reconstruction (ACLR) is often associated with postoperative severe pain. Postoperative early rehabilitation is the primary focus to restore pre-injury status and is an essential part of the full recovery, especially that this rehabilitation extents over a 6 month period. Early elimination of pain is necessary to achieve this goal. However, there are no clear conclusive clinical reports defining the adequate analgesic volume-dosage of local anesthetic for ACB for postoperative ACL pain management. The investigators speculated that volume-dosage manipulation play key role in the effective of ACB for postoperative pain. The investigators conducted this prospective, randomized, observer-blinded trial to compare 3 combinations of volume and dosage of 0.25 % bupivacaine for US-guided ACB. The first aim of the investigation is to compare the analgesic effect of ACB 0.25% bupivacaine of the 3 doses as assessed by the visual analog scale (VAS) pain scores. The second aim were duration of analgesia, as defined by first demand for analgesia, and subsequent 24-h consumption. Physiotherapy tolerance and time to discharge were evaluated. Side effects were also assessed.

Read the detailed description

After institutional review board approval and informed written consent, 90 males patients, elective unilateral arthroscopic anterior cruciate ligament reconstruction surgery under general anesthesia, The investigators enrolled adult male patients aged 18 to 50 yr, with American physical classification (ASA) I, II body mass index ≤ 35 kg/m2 and surgery lasting less than 2 h. Exclusion criteria were: infection at the side at the procedure site, patients with diabetes mellitus, intake of any analgesic during the last 48h, history to local anesthetics allergy.

After arrival in the operating room, an 18-gauge intravenous in the upper limb catheter and ASA standard monitoring was placed. Standard intravenous premedication (3 mg of midazolam and 50 mcg of fentanyl) was given to all patients and supplemental oxygen was administered via facemask (5 L/min) throughout the block period. All Patients were randomly allocated to received an ultrasound-guided (GE Logic; GE, USA) ACB with 0.25% bupivacaine 1 of 3 solutions: group 1 (G20) 20 ml, group 2 (G25) 25 ml and group 3 (G30) 30 ml. ACB was performed in supine position at the mid-thigh level with leg slightly rotated externally. After skin sterilization, a 100-mm 21Gauge needle inserted in-plane through the sartorius muscle and fascia and next to the femoral artery into the adductor canal. Three anesthesia operators participated in the study: the first operator performs all US-guided needles insertion, the second operator perform the injection of the local solution. Blinding of the first operator was ensured as follow: (i) the first operator was unaware of volume-dose injected with his back toward to the second operator. (ii) the second operator using opaque syringes. The solution was injected in increment doses after negative aspiration to avoid intravascular injection. The blinded third operator performed the postblock assessment of sensory block and motor blockade flowing the block placement. All patients were evaluated for block success by checking pinprick and cold sensation in the saphenous distribution on the lower medial leg using a 25-gauge needle and a 3-point scale (0 = normal sensation, 1 = cold touch without pinprick, and 2 = absence of sensation). Successful blockade was defined as a change from normal sensation at baseline (0) to a score of 1 or 2. Sensation was tested at 15 and 30 minutes after nerve block and if block success was not achieved after 30 min, the operator consider the block as failure. Motor assessment was performed every 15 min up to 60 mn using a handheld isometric force electromechanical dynamometer (MicroFET2; Hoggan Health Industries Inc., USA) for quadriceps muscle power evaluation. Before the operation, all patients received instructions for using a 100-mm VAS score (with 0 = no pain, to 100 = the worst imaginable pain). Hereafter, all patients received standard general anesthesia and were induced with propofol (2.5 mg/kg), cisatracurium (0.2 mg/kg) and fentanyl (0.002 mg/kg) and maintained with nitrous oxide 50% in oxygen and sevoflurane. No other supplementary analgesic medication was given during the operation after the first dose of fentanyl. During anesthesia, controlled ventilation was performed via an endotracheal tube. Before surgical incision, a thigh pneumatic tourniquet on the same side as the surgery, at a pressure of 300 mm Hg, was applied to all patients. The same surgeon performed all surgical procedures using a standard surgical technique.

After the end of anesthesia, patients were transferred to the post-anesthesia care unit (PACU). Arrival at PACU was recorded as time zero. The VAS was assessed at predetermined intervals after surgery (0, 15, 30, 45, 60, 90, 120 min) and following PACU discharge at 4, 6, 12, and 24 h. In PACU, when the VAS was greater than 4, IV morphine was titrated every 5min by 3mg. Pain was assessed every 5 min until pain relief, defined as a VAS ≤ 4. The modified Aldrete score were used to assure safe PACU discharge. Following PACU discharge, the first 24-h analgesia consisted of Pethidine 25 to 50 mg IV infusion repeated every 2 to 4 h as required. VAS score measurement in PACU and the first 24 postoperatively were assessed. PACU Morphine consumption and subsequent 24 -pethidine consumption were recorded. In addition, Time to discharge and the tolerance of physiotherapy as evaluated using VAS 10 points-scale were assessed : 0 - 3 = easy physiotherapy well tolerated rated as 1 , 4 - 6 = physiotherapy is tolerated with moderate pain rated as 2 and 7 - 10 = physiotherapy is painful and not tolerated rated as 3 . Systemic side effects of analgesia were also reported.

Being tested
Bupivacaine
Medical subject headings
Pain, Postoperative

What participants receive

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

  • BupivacaineDrug

    Also called Marcaine

    comparison of different volumes-dosages of 0.25% Bupivacaine

Study groups in NCT02805920
Study groupRoleWhat they receive
GROUP 1 : G20Active comparatorPostoperative pain for ACLR : G20 : received ACB with 20 ml 0.25% Bupivacaine
Receives: Drug: Bupivacaine
GROUP 2 : G25Active comparatorPostoperative pain for ACLR : G25: received ACB with 25 ml 0.25% Bupivacaine
Receives: Drug: Bupivacaine
GROUP 3 : G30Active comparatorPostoperative pain for ACLR : G30 received ACB with 30 ml 0.25% Bupivacaine
Receives: Drug: Bupivacaine

What is being measured

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

  1. postoperative pain

    assessment by the visual analog scale (VAS) pain scores. Analgesic consumption

    Measured: 24 days hours

Secondary outcomes (2)
  1. Physiotherapy tolerance

    evaluated using VAS 10 points-scale were recorded : 0 - 3 = easy physiotherapy well tolerated rated as (1) , 4 - 6 = physiotherapy is tolerated with moderate pain rated as (2) and 7 - 10 = physiotherapy is painful and not tolerated rated as (3) .

    Measured: 3 days

  2. Time to discharge

    time to discharge is measured by days : starting on the day of surgery till the day of discharge home

    Measured: 3 days

Timeline

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

  1. First posted20 Jun 2016 (estimated)
  2. Study start30 Aug 2016
  3. Primary completion30 Apr 2017
  4. Study completion30 Jun 2017

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
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02805920
Sponsor's protocol ID
PRH10
Status last verified
Aug 2018
First submitted
12 Jun 2016
Last updated
14 Aug 2018
Results posted
No
Data monitoring committee
Yes
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 Bupivacaine in people with Postoperative Pain, run by Procare Riaya Hospital at 2 sites in Saudi Arabia.

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 3 inclusion and 4 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 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Saudi Arabia. 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. 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?

postoperative pain (time frame: 24 days 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 14 Aug 2018.

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