Postoperative PainNCT03498092
Dexmedetomidine in Serratus Plane Block for Mastectomy
A study testing Bupivacaine-Dexmedetomidine, Bupivacaine and General anesthesia in people with Postoperative Pain, run by Alaa Mazy at 1 site in Egypt.
Trial summary
The serratus plane block (SPB) described by Blanco et al, 2013 is a progression from the work with the Pecs I and II blocks. The serratus muscle is a superficial and easily identified muscle and considered a true landmark to perform thoracic wall blocks because lateral cutaneous branches of the intercostal nerves… Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Bupivacaine-Dexmedetomidine, Bupivacaine and General anesthesia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Aug 2016to 8 Oct 2018
- 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 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients of American Society of Anesthesiologists (ASA) grade I - III.
- Scheduled for unilateral modified radical mastectomy.
Who cannot join
- Patient with the skin infection in the axilla.
- Allergy to local anesthetics of the amide type.
- Patient refusal.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of Bupivacaine Versus Bupivacaine-Dexmedetomidine in Ultrasound Guided Serratus Plane Block for Patients Undergoing Modified Radical Mastectomy
The serratus plane block (SPB) described by Blanco et al, 2013 is a progression from the work with the Pecs I and II blocks. The serratus muscle is a superficial and easily identified muscle and considered a true landmark to perform thoracic wall blocks because lateral cutaneous branches of the intercostal nerves pierce it in the mid-axillary line. A local anesthetic (LA) is injected under ultrasound (US) guidance either superficial or deep to serratus anterior muscle providing predictable and relatively long-lasting regional anesthesia, which would be suitable for surgical procedures performed on the chest wall.
The linear US probe of frequency (6-13 MHz) is placed over the mid-clavicular region in a sagittal plane.The ribs are counted inferiorly and laterally until the fifth rib in the midaxillary line is identified.The latissimus dorsi, teres major, and serratus muscles are identified.
Read the detailed description
Possible regional techniques for breast surgery include selective intercostal nerve blockade, thoracic paravertebral blockade, thoracic epidural, intrapleural, local wound infiltration. Each of these techniques has advantages and disadvantages. In general, local or wound infiltration is safe but limited in terms of duration of action, depending on the local anesthetic (LA) used. More invasive techniques such as selective intercostal nerve blocks and thoracic paravertebral blockade may be complicated by pneumothorax or transient Horner's syndrome These techniques are also may be associated with higher risk of local anesthetic toxicity. Besides the neurological side-effects associated with thoracic epidural and paravertebral blocks such as post-sympathectomy hypotension and bradycardia, total spinal block, paraplegia, epidural hematoma, unpredictable spread, intravascular injection also requires special skill precluding their routine use in the setting of day-case surgery. With the use of ultrasound (US) devices in anesthetic practice, newer regional techniques based on detailed knowledge of innervations of the breast are developed as the pectoral nerve (Pecs) block I and II.The breast innervations briefly include lateral and medial pectoral nerves that arise from the brachial plexus innervating the pectoral muscles.The anterior divisions of the thoracic intercostal nerves from T2 to T6. They give off lateral and anterior branches. The Lateral branches pierce the external intercostalis and the serratus anterior muscles at the mid-axillary line to give off anterior and posterior terminal cutaneous branches. The lateral cutaneous branch of the second intercostal nerve does not divide and it is called the intercostobrachial nerve.The Anterior branches pierce the internal intercostalis muscle, the intercostal membranes, and pectoralis major to supply the breast in its medial aspect.The long thoracic nerve passes on the serratus anterior muscle supplying it. The thoracodorsal nerve innervates the latissimus dorsi muscle.
- Conditions
- Postoperative Pain
- Being tested
- Bupivacaine-Dexmedetomidine, Bupivacaine, General anesthesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine-DexmedetomidineDrug
isobaric bupivacaine 2.5 mg/ml plus 5 micro gram/ml adrenaline and 1 micro gram/kg dexmedetomidine in a volume of 0.5 ml/kg
BupivacaineDrug
isobaric bupivacaine 2.5 mg/ml plus 5 micro gram/ml adrenaline in a volume of 0.5 ml/kg
General anesthesiaDrug
Normal saline in a volume of 0.5 ml/kg
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine-Dexmedetomidine group | Experimental | After general anesthesia, patients will receive a cocktail of isobaric bupivacaine 2.5 mg/ml plus 5 micrograms (mcg)/ml adrenaline and 1mcg/kg dexmedetomidine in a volume of 0.5 ml/kg injected superficial to serratus muscle between and below latissimus dorsi muscle. Receives: Drug: Bupivacaine-Dexmedetomidine |
| Bupivacaine group | Active comparator | After general anesthesia, patients will receive a cocktail of isobaric bupivacaine 2.5 mg/ml plus 5 micrograms (mcg)/ml adrenaline in a volume of 0.5 ml/kg injected superficial to serratus muscle between and below latissimus dorsi muscle. Receives: Drug: Bupivacaine |
| Saline group | Placebo comparator | This group will serve as a control and blinding group and will receive saline infiltration in the same manner. Receives: Drug: General anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time of the first analgesia request
minutes
Measured: 24 hours postoperative
Secondary outcomes (8)
The total analgesic requirements (Ketorolac)
milligram
Measured: 24 hours postoperative
Pain assessed by Visual Analogue Scale
Visual Analogue Scale: between 0 and 10 (0 representing no pain and 10 is the worst imaginable pain)
Measured: Postoperative: immediately after surgery, 2, 4, 6,10, 16, 24 hours postoperative
Amount of fentanyl consumption
microgram
Measured: Intraoperative.
Mean arterial blood pressure
millimeter mercury
Measured: intraoperative every 30 minutes, and postoperative at 2, 4, 6, 10, 16, 24 hours
Heat rate
Beat per minute
Measured: intraoperative every 30 minutes, and postoperative at 2, 4, 6, 10, 16, 24 hours
Sedation assessed by the observer's assessment of alertness & sedation score
sedation score (1-5):
5 = patient respond to name spoken in normal voice.
4 = patient asleep but arousable to normal tone voice.
3 = patient asleep but arousable to loud voice.
2 = patient asleep but arousable by mild prodding or shaking.
1 = comatose.
Measured: postoperative:10, 20, 30 minutes after extubation
The Incidence of postoperative nausea and vomiting
percent
Measured: postoperative for 24 hours
Patient satisfaction assessed by a visual analogue score
A score (0-10): 0 is the least satisfaction,10 the maximum satisfaction.
Measured: postoperative 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start8 Aug 2016
- Primary completion8 Oct 2018
- Study completion8 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alaa Mazy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alaa Mazy, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03498092
- Sponsor's protocol ID
- MD/16.06.08
- Status last verified
- Oct 2018
- First submitted
- 2 Apr 2018
- Last updated
- 23 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Bupivacaine Versus Bupivacaine-Dexmedetomidine in Ultrasound Guided Serratus Plane Block for Patients Undergoing Modified Radical Mastectomy
- ClinicalTrials.gov ID
- NCT03498092
- Acronym / sponsor ID
- MD/16.06.08
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Alaa MazyUniversity, hospital or other
- Study start
- 8 Aug 2016 (actual)
- Primary completion
- 8 Oct 2018 (actual)
- Study completion
- 8 Oct 2018 (actual)
- First posted
- 13 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The serratus plane block (SPB) described by Blanco et al, 2013 is a progression from the work with the Pecs I and II blocks. The serratus muscle is a superficial and easily identified muscle and considered a true landmark to perform thoracic wall blocks because lateral cutaneous branches of the intercostal nerves pierce it in the mid-axillary line. A local anesthetic (LA) is injected under ultrasound (US) guidance either superficial or deep to serratus anterior muscle providing predictable and relatively long-lasting regional anesthesia, which would be suitable for surgical procedures performed on the chest wall.
The linear US probe of frequency (6-13 MHz) is placed over the mid-clavicular region in a sagittal plane.The ribs are counted inferiorly and laterally until the fifth rib in the midaxillary line is identified.The latissimus dorsi, teres major, and serratus muscles are identified.
Detailed description
Possible regional techniques for breast surgery include selective intercostal nerve blockade, thoracic paravertebral blockade, thoracic epidural, intrapleural, local wound infiltration. Each of these techniques has advantages and disadvantages. In general, local or wound infiltration is safe but limited in terms of duration of action, depending on the local anesthetic (LA) used. More invasive techniques such as selective intercostal nerve blocks and thoracic paravertebral blockade may be complicated by pneumothorax or transient Horner's syndrome These techniques are also may be associated with higher risk of local anesthetic toxicity. Besides the neurological side-effects associated with thoracic epidural and paravertebral blocks such as post-sympathectomy hypotension and bradycardia, total spinal block, paraplegia, epidural hematoma, unpredictable spread, intravascular injection also requires special skill precluding their routine use in the setting of day-case surgery. With the use of ultrasound (US) devices in anesthetic practice, newer regional techniques based on detailed knowledge of innervations of the breast are developed as the pectoral nerve (Pecs) block I and II.The breast innervations briefly include lateral and medial pectoral nerves that arise from the brachial plexus innervating the pectoral muscles.The anterior divisions of the thoracic intercostal nerves from T2 to T6. They give off lateral and anterior branches. The Lateral branches pierce the external intercostalis and the serratus anterior muscles at the mid-axillary line to give off anterior and posterior terminal cutaneous branches. The lateral cutaneous branch of the second intercostal nerve does not divide and it is called the intercostobrachial nerve.The Anterior branches pierce the internal intercostalis muscle, the intercostal membranes, and pectoralis major to supply the breast in its medial aspect.The long thoracic nerve passes on the serratus anterior muscle supplying it. The thoracodorsal nerve innervates the latissimus dorsi muscle.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine-Dexmedetomidine group | Experimental | Drug: Bupivacaine-DexmedetomidineAfter general anesthesia, patients will receive a cocktail of isobaric bupivacaine 2.5 mg/ml plus 5 micrograms (mcg)/ml adrenaline and 1mcg/kg dexmedetomidine in a volume of 0.5 ml/kg injected superficial to serratus muscle between and below latissimus dorsi muscle. |
| Bupivacaine group | Active comparator | Drug: BupivacaineAfter general anesthesia, patients will receive a cocktail of isobaric bupivacaine 2.5 mg/ml plus 5 micrograms (mcg)/ml adrenaline in a volume of 0.5 ml/kg injected superficial to serratus muscle between and below latissimus dorsi muscle. |
| Saline group | Placebo comparator | Drug: General anesthesiaThis group will serve as a control and blinding group and will receive saline infiltration in the same manner. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients of American Society of Anesthesiologists (ASA) grade I - III.
- Scheduled for unilateral modified radical mastectomy.
Key exclusion criteria (3 listed)
- Patient with the skin infection in the axilla.
- Allergy to local anesthetics of the amide type.
- Patient refusal.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine-Dexmedetomidineisobaric bupivacaine 2.5 mg/ml plus 5 micro gram/ml adrenaline and 1 micro gram/kg dexmedetomidine in a volume of 0.5 ml/kg | Drug | Bupivacaine-Dexmedetomidine group |
| Bupivacaineisobaric bupivacaine 2.5 mg/ml plus 5 micro gram/ml adrenaline in a volume of 0.5 ml/kg | Drug | Bupivacaine group |
| General anesthesiaNormal saline in a volume of 0.5 ml/kg | Drug | Saline group |
Primary outcome
The time of the first analgesia request
Time frame: 24 hours postoperative
minutes
8 secondary outcomes
The total analgesic requirements (Ketorolac)
Time frame: 24 hours postoperative
Pain assessed by Visual Analogue Scale
Time frame: Postoperative: immediately after surgery, 2, 4, 6,10, 16, 24 hours postoperative
Amount of fentanyl consumption
Time frame: Intraoperative.
Mean arterial blood pressure
Time frame: intraoperative every 30 minutes, and postoperative at 2, 4, 6, 10, 16, 24 hours
Heat rate
Time frame: intraoperative every 30 minutes, and postoperative at 2, 4, 6, 10, 16, 24 hours
Sedation assessed by the observer's assessment of alertness & sedation score
Time frame: postoperative:10, 20, 30 minutes after extubation
The Incidence of postoperative nausea and vomiting
Time frame: postoperative for 24 hours
Patient satisfaction assessed by a visual analogue score
Time frame: postoperative 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine-Dexmedetomidine, Bupivacaine and General anesthesia in people with Postoperative Pain, run by Alaa Mazy 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 2 inclusion and 3 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 23 Oct 2018. 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?
The time of the first analgesia request (time frame: 24 hours postoperative). 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 23 Oct 2018.