AzTrials
AzTrials

AnalgesiaNCT04061668

Single Path Versus Double Path PECS I and II Blocks as an Efficient Analgesic Choice in Female Breast Surgeries.

A study testing single needle path PECS I and II block group and double needle path PECS I and II block group in people with Analgesia, run by Ain Shams 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
Search all trials

Trial summary

The patients are allocated by computer generated random number method into 2 groups: single needle path PECS I and II block group, where patients receive induction with pec I and II blocks which are performed under ultrasound guidance , with a linear ultrasound transducer on the same side of surgery. Read more about this study

Who is it for?
Ages 50 to 65 years, women only
Conditions the study is for
Analgesia
What is being tested?
single needle path PECS I and II block group and double needle path PECS I and II block group
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteEgypt
Study dates
10 Nov 2019to 2 Jul 2020
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 50 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • female patients aged from 50-65 years old elective breast surgeries ASA I II

Who cannot join

  • Refusal to participate inability to communicate with the investigators or hospital staff obesity (body mass index>40 kg/m2) patients undergoing bilateral surgery male patients renal insufficiency (creatinine>1.5 mg/dL) American Society of Anesthesia (ASA) III-IV patients with incomplete medical records

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Ain Shams U

    Cairo, 11566

Other trials in Egypt

About this study

Official title: Single Path Versus Double Path PECS I and II Blocks as an Efficient Analgesic Choice in Female Breast Surgeries. A Prospective Study

The patients are allocated by computer generated random number method into 2 groups: single needle path PECS I and II block group, where patients receive induction with pec I and II blocks which are performed under ultrasound guidance , with a linear ultrasound transducer on the same side of surgery. The patients are placed in the supine position where the elbow was flexed and shoulder will be abducted. The probe is placed inferior to the clavicle . A linear probe and a beveled tip needle will be introduced with an in-plane technique . The US probe is initially placed below outer third of the clavicle after skin sterilization showing pectoralis major and minor muscles and the thoraco- acromial artery then moved infero-laterally to locate fourth rib where pectoralis major and pectoralis minor muscles are visualised . The US probe is then moved toward anterior axillary line till pectoralis minor and serratus anterior muscles are identified at 4th rib at the level of thoraco-acromial artery then the needle is inserted in plane with the probe from caudal to cranial using an inclined manner, 15mL of bupivacaine will be put into the potential space between pectoralis minor muscle and serratus muscle (PECS II) then it will be withdrawn to inject another 15 ml of bupivacaine in the plane between pectoralis muscles . The block will be performed with needle introduced in-plane with the ultrasound probe, and the local anesthetic (LA) injection is visualized .

In double needle path PECS I and II block group The probe is initially placed below outer third of the clavicle after skin sterilization showing pectoralis major and minor muscles and the thoraco- acromial artery then moved inferolaterally to locate fourth rib where pectoralis major and pectoralis minor muscles are visualised, then the needle is inserted in plane with the probe and 15mL of bupivacaine is put into the potential space between pectoralis muscles. In the second puncture , the probe is moved toward anterior axillary line till pectoralis minor and serratus anterior muscles will be identified at 4th rib at the level of thoraco-acromial artery then the needle will be inserted in plane with the probe from caudal to cranial , 15mL of bupivacaine is put into the potential space between pectoralis minor muscle and serratus muscle (PECS II).

Read the detailed description

The patients will be randomly allocated by computer generated random number method into 2 groups: single needle path PECS I and II block group(n = 30) where patients will receive induction with pec I and II blocks which will be performed under ultrasound guidance (S-Nerve; Sono-Site Iberica S.L, Madrid, Spain), with a linear ultrasound transducer(10-12 MHz) on the same side of surgery. The patients will be placed in the supine position where the elbow was flexed and shoulder will be abducted. The probe will be placed inferior to the clavicle . A linear probe and a beveled tip needle will be introduced with an in-plane technique . The US probe will be initially placed below outer third of the clavicle after skin sterilization showing pectoralis major and minor muscles and the thoraco- acromial artery then moved infero-laterally to locate fourth rib where pectoralis major and pectoralis minor muscles will be visualised . The US probe was then moved toward anterior axillary line till pectoralis minor and serratus anterior muscles will be identified at 4th rib at the level of thoraco-acromial artery then the needle will be inserted in plane with the probe from caudal to cranial using an inclined manner, 15mL of bupivacaine 0.25% after negative aspiration will be put into the potential space between pectoralis minor muscle and serratus muscle (PECS II) then it will be withdrawn to inject another 15 ml of bupivacaine 0.25% in the fascial plane between pectoralis muscles . The block will be performed with needle (22-G, 80-mm (SonoTap, Pajunk, Geisingen, Germany) introduced in-plane with the ultrasound probe, and the local anesthetic (LA) injection will be visualized in real-time .

In double needle path PECS I and II block group (n = 30) The US probe will be initially placed below outer third of the clavicle after skin sterilization showing pectoralis major and minor muscles and the thoraco- acromial artery then moved inferolaterally to locate fourth rib where pectoralis major and pectoralis minor muscles will be visualised, then the needle will be inserted in plane with the probe and 15mL of bupivacaine 0.25% after negative aspiration will be put into the potential space between pectoralis muscles. In the second puncture , the US probe will be moved toward anterior axillary line till pectoralis minor and serratus anterior muscles will be identified at 4th rib at the level of thoraco-acromial artery then the needle will be inserted in plane with the probe from caudal to cranial in an inclined way, 15mL of bupivacaine 0.25% after negative aspiration will be put into the potential space between pectoralis minor muscle and serratus muscle (PECS II). After 15 minutes of the block, surgical incision will be allowed. Drug packs will be prepared before commencement of the study by a pharmacist unaware of the nature of the study. Inadequate analgesia is defined as more than 20% increase in mean blood pressure and/or heart rate after skin incision and during surgical procedure which will be managed by administration of 1 μg/kg fentanyl. The average end-tidal isoflurane, total intraoperative fentanyl dose will be recorded. In case of failure of the block patient will be excluded.At the end of the surgical procedure, anesthesia will be discontinued and neuromuscular blockade will be reversed with neostigmine(0.05 mg/kg) IV and atropine iv (0.03 mg/kg).Patients will be extubated and shifted to the post-anesthesia care unit. In postoperative anaesthesia care unit, postoperative monitoring of the hemodynamics will be undergone by a well trained nurse who will be blinded to the study and the sensory level of the block was tested using the cold test, done by a blinded physician to the nature of the study after the operation.

.Before induction of anesthesia patients will be teached how to use a 100 cm visual analog scale (VAS) 0 =''no pain" and 100 =''worst imaginable pain"). If VAS score > 4 then a rescue dose of a fentanyl 1.0 μg kg-1 i.v. bolus will be given.

The primary outcome measures will include time of performance of each technique.

The secondary outcomes will include total dose of postoperative fentanyl consumed, visual analogue scores in addition to vital signs will be assessed at 2, 6, 10, 12, 18, 24 h by an investigator blinded to the group allocation and the nature of the study. postoperative adverse events such as hypotension and respiratory depression, postoperative nausea and vomiting (PONV) which will be evaluated using a four-point numerical scale (0=no PONV, 1=mild nausea, 2=severe nausea or vomiting once, and 3=vomiting more than once). The rescue dose of ondansetron 0.1 mg kg-1 will be given i.v. if the score is 2 or more.Moreover, the time to first dose of rescue analgesic.

Conditions
Analgesia
Being tested
single needle path PECS I and II block group, double needle path PECS I and II block group
Keywords
PECS, bupivacaine
Medical subject headings
Agnosia

What participants receive

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

  • single needle path PECS I and II block groupOther

    Also called single needle path PECS I and II block

    The probe is placed inferior to the clavicle . The US probe is placed below outer third of the clavicle showing pectoralis major and minor muscles and the thoraco- acromial artery then moved infero-laterally to locate fourth rib where pectoralis major and pectoralis minor muscles will be visualised . The probe is moved toward anterior axillary line till pectoralis minor and serratus anterior muscles ise identified at 4th rib at the level of thoraco-acromial artery , the needle is inserted in plane with the probe from caudal to cranial using an inclined manner, 15mL of bupivacaine is put into the potential space between pectoralis minor muscle and serratus muscle (PECS II) then it is withdrawn to inject another 15 ml of bupivacaine in the plane between pectoralis muscles . The block will be performed with needle introduced in-plane with the ultrasound probe, and the local anesthetic injection is visualised.

  • double needle path PECS I and II block groupOther

    Also called double needle path PECS I and II block

    The US probe will be initially placed below outer third of the clavicle after skin sterilization showing pectoralis major and minor muscles and the thoraco- acromial artery then moved inferolaterally to locate fourth rib where pectoralis major and pectoralis minor muscles will be visualised, then the needle will be inserted in plane with the probe and 15mL of bupivacaine 0.25% after negative aspiration will be put into the potential space between pectoralis muscles. In the second puncture , the US probe will be moved toward anterior axillary line till pectoralis minor and serratus anterior muscles will be identified at 4th rib at the level of thoraco-acromial artery then the needle will be inserted in plane with the probe from caudal to cranial in an inclined way, 15mL of bupivacaine 0.25% after negative aspiration will be put into the potential space between pectoralis minor muscle and serratus muscle (PECS II).

Study groups in NCT04061668
Study groupRoleWhat they receive
single needle path PECS I and II block group(OtherThe probe is placed inferior to the clavicle . A probe and needle is introduced with in-plane technique . The US is placed below outer third of the clavicle showing pectoralis major and minor muscles then moved infero-laterally to locate fourth rib where pectoralis major and pectoralis minor muscles is visualised . The US probe is moved toward anterior axillary line till pectoralis minor and serratus anterior muscles will be identified at 4th rib at the level of thoraco-acromial artery then the needle is inserted from caudal to cranial using an inclined manner, 15mL of bupivacaine 0.25% is put between pectoralis minor muscle and serratus muscle (PECS II) then it is withdrawn to inject 15 ml of bupivacaine in thel plane between pectoralis muscles . The block will be performed with needle introduced in-plane with the ultrasound probe, and the local anesthetic injection will be visualized .
Receives: Other: single needle path PECS I and II block group
double needle path PECS I and II block groupSham comparatorThe probe will be placed below outer third of the clavicle showing pectoralis major and minor muscles and the thoraco- acromial artery then moved inferolaterally to locate fourth rib where pectoralis major and pectoralis minor muscles are visualised, then the needle is inserted in plane with probe and 15mL of bupivacaine are put into between pectoralis muscles. In the second puncture , the US probe is moved toward anterior axillary line till pectoralis minor and serratus anterior muscles are identified , the needle will be inserted in plane with the probe from caudal to cranial , 15mL of bupivacaine will be put into the potential space between pectoralis minor muscle and serratus muscle (PECS II).
Receives: Other: double needle path PECS I and II block group

What is being measured

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

  1. time of performance of each technique

    duration of performance of each technique

    Measured: 10 to 15 minutes

Secondary outcomes (1)
  1. total dose of postoperative fentanyl consumed

    dose of rescue analgesic

    Measured: 24 hours after the procedure

Timeline

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

  1. First posted20 Aug 2019
  2. Study start10 Nov 2019
  3. Primary completion30 Jun 2020
  4. Study completion2 Jul 2020

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
Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04061668
Sponsor's protocol ID
FMASU R 04/ 2019
Status last verified
Jul 2020
First submitted
17 Aug 2019
Last updated
3 Aug 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: study protocol statistical analysis data analysis

Questions about this trial

What is this clinical trial studying?

A study testing single needle path PECS I and II block group and double needle path PECS I and II block group in people with Analgesia, run by Ain Shams 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 1 inclusion and 1 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 3 Aug 2020. 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?

time of performance of each technique (time frame: 10 to 15 minutes). 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 3 Aug 2020.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in