Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04311255 |
| Other study ID # |
FMASU R 25/2019 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
April 13, 2019 |
| Est. completion date |
May 3, 2020 |
Study information
| Verified date |
May 2020 |
| Source |
Ain Shams University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In our study we are trying to reach to the more efficient us guided peripheral nerve block
either intercosto-brachial or PPEC 11 that can be combined with us guided supraclavicular
block to effectively anesthetise the surgical site for creation of brachio-basilic fistula as
regarding onset of surgical anesthesia, adequacy of intra-operative anesthesia, the need for
surgical wound infiltration, duration of postoperative analgesia and the failure rate of the
fistulae.
Description:
- Type of Study: Randomized Prospective trail
- Study Setting: Ain Shams University Hospitals, Cairo, Egypt
- Study Period: 6 months.
Sampling Method: Patients will be subdivided randomly into two groups :
Group (SI) : 25 ml of bupivacaine 0.5 % for us guided supraclavicular block plus 10 ml of
lidocaine 2% for us guided intercostobrachial nerve block.
Group(SP) : 25 ml of bupivacaine 0.5 % for us guided supraclavicular block plus10 ml of
lidocaine 2% for us guided PECll block.
Study Procedures:
Following local university ethical committee approval, informed consent will be obtained.
Details of the anesthetic technique and the study protocol will be fully explained at the
preoperative visit, and written consent will be obtained from each patient before inclusion
in the study. The patients has to have normal prothrombin (PT) and partial thromboplastin
(PTT) times before the procedure.
In the pre-induction room the patients will be taught how to assess their own pain score
using the numerical rating scale (NRS) (0-10; 0 = no pain, 10 = worst imaginable pain) .
On arrival at the operating room, standard monitoring will be established with five lead
electrocardiogram, non-invasive blood pressure measurement and pulse oximeter. After
insertion of a 20-gauge intravenous cannula in the non operated arm, an intravenous
crystalloid solution will be administered. Supplemental oxygen will be supplied through nasal
cannula. The oxygen flow will be set at 3 L/ min.
Patients will receive 1-2 md midazolam intravenous as premedication before the block. All
blocks will be performed by one of the authors, The patients will be randomly allocated to
one of the two groups, either supraclavicular-intercostobrachial group(SI Group) ,or the
supraclavicular-Pec 11 group(SP Group) .
The patient in SI Group is placed in a semi-sitting position by elevating the head of bed 45
degrees with the patients head turned to the opposite site to be blocked. The skin of the
neck and the upper chest and axilla and medial upper arm will be prepared in an aseptic
fashion. Ultrasound examination of the supraclavicular area will be performed using a 38-mm
high frequency (9-12 MHz) linear array transducer with the in-plane approach, will receive 25
ml of 0.5% bupivacaine in the supraclavicular area ,then the operated arm will be abducted
and externally rotated, and the elbow flexed to 90°. Ultrasound examination of the medial
upper arm will be performed using a 38-mm high frequency (9-12 MHz) linear array transducer
and the intercosto-brachial nerve is identified and blocked using 10 ml of lidocaine 2% . The
patient in SP Group will also have supraclavicular block that will be performed in the same
way as the previous group and then patient is placed in the supine position with the arm
abducted 90 degrees position to receive Peg 11 lock by injecting 10ml of lidocaine 2% between
pectoralis minor and serratus anterior at 3rd rib level using a 38-mm high frequency (9-12
MHz) linear array transducer with the in-plane approach. The sensory and motor blocks will be
evaluated every 5 min for 30 min or until blocks will be complete. An adequate surgical
anesthesia will be defined as a motor score of ≥1 , with an absence of pinprick sensations in
the area of all the four terminal nerves.
The zero time for onset of sensory and motor blocks will be the completion of the LA
injection. Sensory block assessment (0, no block 1, loss of sensation of pinprick 2, loss of
sensation of touch) will be performed in the innervations of the four nerve areas, radial
(radial dorsum of the hand), median (thenar eminence), ulnar (hypothenar eminence),and
intercostobrachial (medial upper arm) corresponding to the nerve distributions in the forearm
and hand using the pinprick test, and will be compared with the same stimulation on the
contra-lateral arm. The degree of motor block will be evaluated by thumb abduction (radial
nerve), thumb adduction (ulnar nerve), and thumb opposition (median nerve), using a 3-point
scale (0 =normal motor function, 1 = decreased motor strength, 2 = complete motor block). The
onset times of the sensory block (the time between the end of the LA injection and the total
abolition of the pinprick response) and motor block (time between the end of the LA injection
and complete motor block) will be recorded for each nerve. Patients who will not achieve
satisfactory levels of anesthesia and will need intraoperative local infiltration will be
recorded .Patient in whom the block failed and local infiltration is not enough will receive
general anesthesia (propofol 2mg/kg plus fentanyl 1ug/kg and atracurium 0.5mg/kg ) with
laryngeal mask airway inserted for mechanical ventilation .
Postoperative pain will be assessed by one of the authors using a visual analog scale (0, no
pain; 10, worst pain imaginable). Analgesic for the first complain of pain will be
standardized and consisted of 500 mg of oral or intravenous paracetamol given for a pain
score of 4 of visual analog scale.The time to first analgesic requirement will be also
recorded by the same author.
Heart rate, peripheral oxygen saturation, respiratory rate, and blood pressure will be
measured before the supraclavicular block and 5, 10, 20, 30, 45, and 60 min after the block
and thereafter every 60 min for 2 h postoperatively. University of Michigan Sedation Scale
(UMSS) (1, awake and alert; 2, sedated, responding to verbal stimulus; 3, sedated, responding
to strong physical stimulus; 4, not arousable) will be measured first as baseline before the
block then at the same time points for measuring vital signs post-block .
