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AnalgesiaNCT04284124

Erector Spinae Block Versus PECS Block Type II for Breast Surgeries

A study testing Erector Spinae block in people with Analgesia, run by National Cancer Institute, Egypt 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

The purpose of this randomized, controlled prospective study is to compare the analgesic effect of US-guided ESP block versus PECs block in patients undergoing breast surgery for breast cancer in the National Cancer Institute, Cairo University. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Analgesia
What is being tested?
Erector Spinae block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
19 Mar 2020to 10 Mar 2021
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ASA I-II
  • Adult patients (>18 years old)
  • Female sex
  • Scheduled for breast surgeries at NCI, CU

Who cannot join

  • Patient's refusal of the study procedures
  • Allergy to drugs used in the study
  • Patients with chronic pain and chronic use of opioids
  • Patients with coagulopathies (INR > 1.6 or platelets count < 50,000 cc3)
  • Hemodynamically unstable patients (e.g. BP < 90/60)
  • Patients with local or systemic infections concerning intervention sites and septic patients

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • NCI Egypt

    Cairo, 02002

Other trials in Egypt

About this study

Official title: Erector Spinae Block Versus PECS Block Type II for Breast Surgeries: a Randomized Controlled Trial

The purpose of this randomized, controlled prospective study is to compare the analgesic effect of US-guided ESP block versus PECs block in patients undergoing breast surgery for breast cancer in the National Cancer Institute, Cairo University. We aim to evaluate the postoperative pain intensity and opioid consumption within 24 hours

Read the detailed description

This prospective, randomized controlled trial will include 30 adult female patients below 65 years of age scheduled for surgery for breast cancer. Inclusion criteria will include also American Society of Anesthesiologists (ASA) physical status I-II and unilateral surgery. Exclusion criteria will include obesity defined as body mass index > 35 kg/m2), known allergy to the study drugs, coagulopathy, skin infection at the site of needle puncture, and recent use of opioid drugs.

Patients will be assessed the day before surgery in a preoperative visit for evaluation of their medical status and laboratory investigations. They will be informed about the technique of the blocks and written informed consents will be obtained. All patients will be informed how to report pain on a numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain). In the pre-anesthetic room, midazolam 0.02 mg/kg IV will be given to the patients for sedation after fixation of a 20 G cannula as an IV line. Randomization will be done using consecutively numbered opaque sealed envelopes. Patients will be randomized into two groups according to the type of analgesia. The first group will receive single-shot ESP block (ESP group) and the other group will receive PECs II block (PECs group).

ESP technique:

ESP block will be performed in following standardized monitoring, including noninvasive blood pressure, electrocardiogram, and pulse oximetry. It will be done unilaterally with the patient in the prone position about 20 min before induction of general anesthesia. Skin is prepared by 10% povidone iodine. The US probe will be covered with a sterile cover. All blocks will be by the same anesthesiologists who are experienced in US-guided nerve blocks. An ultrasound machine with a large bandwidth, multifrequency convex probe (1-8 MHz) will be used for block performance. A 22G, 50-mm, insulated facet type needle will be used during all blocks. The blocks will be performed at the T4 level of the spine using an in-plane approach. A convex probe will be placed 2-3 cm laterally to the spine using a sagittal approach. Once the erector spinae muscle and the transverse processes is identified, the needle will be inserted deep into the muscle. The needle will be directed from a cranial to a caudal direction. Following confirmation of the correct position of the needle tip with administration of 0.5-1 ml of local anesthetic, 20 ml of 0.25% bupivacaine will be administered for block performance. Distribution of local anesthetic will be observed in both cranial and caudal directions.

PECs II block Technique:

The block will be done unilaterally about 20 min before induction of general anesthesia. Under standardized monitoring, the patient is put in the supine position with the ipsilateral arm abducted and externally rotated and the elbow flexed 90 degrees. The skin over the ipsilateral clavicle and small area below it is done by betadine. The high frequency probe is put in the ipsilateral clavipectoral triangle between the clavicle medially and above and the shoulder joint laterally. The pectoralis major and minor and the plane between them are identified. The probe is tilted caudally to identify the pulsating thoracoacromial artery or its pectoral branch. The skin at the point of entry is infiltrated by xylocaine 1% then the needle is advanced in an in plane technique targeting the space in which the artery is located. Two cm of normal saline is injected to confirm the location and produce dissection. Then, 10 ml of bupivacaine 0.25% with epinephrine 2.5 µg/ml is injected. Propofol is given in 20 mg boluses followed by normal saline flush to produce more sedation just before injecting the bupivacaine because dissection is painful. Then the probe is moved laterally and caudally towards the anterior axillary fold parallel to the deltopectoral groove till the serratus muscle slips appear underneath the pec minor attached to the underlying ribs. The 3rd and 4th ribs and the pleura are identified. After infiltration of the skin with xylocaine 1% the needle is advanced in plane targeting the plane between pec minor and serratus at the level of the third rib. Two ml of normal saline is injected for confirmation of the needle tip then 20 ml of bupivacaine 0.25% with epinephrine 2.5 µg /ml is injected. A pinprick test is done after 15 minutes to assess sensory block compared to the unblocked contralateral side. A block is considered unsuccessful and the patient is excluded from the study if the site of surgical incision is not blocked after 20 min of LA injection.

General anesthesia Standard anesthesia monitoring will be applied, and induction of general anesthesia will be carried out by using fentanyl (1µg/kg) IV, propofol (2 mg/kg) IV and cisatracurium (0.15mg/kg) IV. Paracetamol 1 gm/100 ml IV infusion and ketolac 30 mg IV slowly is given before surgical incision. Paracetamol 1 gm/100 ml IV infusion is given every 8 hours and ketolac 30 mg every 12 hours. Anesthesia will be maintained by sevoflurane 2% in O2 and supplemental doses of cisatracurium (0.03 mg/kg) IV as indicated by peripheral nerve stimulator by appearance of the second twitch of the train of four (TOF). Additional bolus doses of fentanyl 0.5 µg /kg will be given if the mean arterial blood pressure and/or heart rate rise above 20% of baseline. The patients will receive fluids in order to replace their fluid deficit, maintenance and losses, and will be mechanically ventilated at appropriate setting that keep end-tidal CO2 at 30-35 mmHg. Hypotension will be treated with 0.9% normal saline, 6% hetastarch in saline and/or 5mg ephedrine in incremental doses in order to maintain mean blood pressure above 70 mmHg. Recovery will be carried out after closure of surgical wound by turning off sevoflurane vaporizer and reversal will be given after TOF ratio becomes 0.7 and fully awake extubation will be done and then the patient will be transferred to post anesthesia care unit (PACU)

In the PACU, VAS is assessed by a nurse blinded to the intervention done. It will be assessed immediately postoperative, and then 1, 2, 6, 12, and 24 hours post-extubation. Patients will be given 2 mg morphine slowly IV when VAS > 3, repeated 2 times if required (total 3 boluses) to keep VAS ≤ 3, at least 10 minutes between each bolus, then 1 mg morphine is given slowly IV if required, at least 15 minutes between each bolus. Nausea and/or vomiting are treated by metoclopramide 10 mg/8 hours slowly IV. Incidences of nausea and vomiting, and total morphine consumption during the 24-h postoperative period were recorded.

The primary outcome measure of the study will be total morphine consumption during the first 24 postoperative hours. The secondary outcome measures will be duration of analgesia, postoperative pain scores up to 24 hours postoperative, and occurrence of postoperative nausea and vomiting.

Conditions
Analgesia
Being tested
Erector Spinae block
Medical subject headings
Agnosia

What participants receive

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

  • Erector Spinae blockOther

    Patient in the prone position 20 min before induction of general anesthesia. Skin is sterilized by 10% povidone iodine. An US multifrequency convex probe (1-8 MHz) will be used for block. A 22G, 50-mm in length needle will be used and block will be performed at the T4 level of the spine using in-plane approach where a convex probe is placed 2-3 cm lateral to the spine using sagittal approach. Erector spinae muscle and the transverse processes are located and the needle will be inserted deep into the muscle. The needle is directed craniotomy-caudally. Correct position of the needle tip is confirmed with administration of 0.5-1 ml of local anesthetic to monitor spread then 20 ml of 0.25% bupivacaine will be administered for block performance. Distribution of local anesthetic is monitored in both cranial and caudal directions

Study groups in NCT04284124
Study groupRoleWhat they receive
Erector Spinae blockActive comparatorDone unilaterally with the patient in the prone position about 20 min before induction of general anesthesia. Skin is prepared by 10% povidone iodine. An ultrasound machine with a large bandwidth, multifrequency convex probe (1-8 MHz) will be used for block performance. A 22G, 50-mm, at the T4 level of the spine using an in-plane approach. Probe is placed 2-3 cm laterally to the spine using a sagittal approach. Once the erector spinae muscle and the transverse processes is identified, the needle will be inserted deep into the muscle. The needle will be directed from a cranial to a caudal direction. Following confirmation of the correct position of the needle tip with administration of 0.5-1 ml of local anesthetic, 20 ml of 0.25% bupivacaine will be administered for block performance. Distribution of local anesthetic will be observed in both cranial and caudal directions.
Receives: Other: Erector Spinae block
PECS type II blockActive comparatorDone unilaterally, patient is put in the supine position with ipsilateral arm abducted and externally rotated with elbow flexed 90 degrees. High frequency probe is put in the ipsilateral clavipectoral triangle between the clavicle medially and above and the shoulder joint laterally. The pectoralis major and minor and the plane between them are identified guided by pulsating thoracoacromial artery or its pectoral branch. Needle is advanced in plane targeting the space where the artery is located, 2ml of normal saline is injected to confirm the location. Then, 10 ml of bupivacaine 0.25% is injected. Probe is moved laterally and caudally towards the anterior axillary fold parallel to the deltopectoral groove till the serratus muscle slips appear underneath the pec minor attached to the underlying ribs. Targeting the plane between pec minor and serratus at the level of the third rib, 2 ml of normal saline is injected for confirmation of the needle tip then 20 ml of bupivacaine 0.25%.
Receives: Other: Erector Spinae block

What is being measured

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

  1. Total morphine consumption for 24 hours post operatively

    The primary outcome measure of the study will be total morphine consumption during the first 24 postoperative hours.

    Measured: 24 hours

Secondary outcomes (3)
  1. duration of analgesia

    duration of analgesia post operatively

    Measured: 24 hours

  2. post operative pain scores using numerical rating scale

    post operative pain scores using numerical rating scale (NRS) for 24 hours with 0 to no pain and 10 to most severe pain

    Measured: 24 hours

  3. post operative nausea and vomiting using nausea score

    post operative nausea and vomiting for 24 hours using nausea score with 0 for no nausea, 1 for mild nausea, 2 for moderate nausea, 3 for severe 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 Feb 2020
  2. Study start19 Mar 2020
  3. Primary completion10 Mar 2021
  4. Study completion10 Mar 2021

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04284124
Sponsor's protocol ID
AP2001-50504
Status last verified
Oct 2021
First submitted
18 Feb 2020
Last updated
2 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Erector Spinae block in people with Analgesia, run by National Cancer Institute, Egypt 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 6 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 2 Nov 2021. 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. 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?

Total morphine consumption for 24 hours post operatively (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 2 Nov 2021.

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