Acute Post-mastectomy Pain TreatmentNCT06175741
Adding Morphine to ESP Block in Management of Acute PMP
A study testing erector spinae plane block in people with Acute Post-mastectomy Pain Treatment, run by Assiut University.
Trial summary
The aim of the study is to determine the efficacy of adding morphine in two doses (3mg, 5mg) to erector spinae plane block in relieving acute post mastectomy pain Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Acute Post-mastectomy Pain Treatment
- What is being tested?
- erector spinae plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Mar 2026
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1/female patients aged from 18 to 60 years.
- 2/ASA I -II
- 3/Surgery is modified radical mastectomy
Who cannot join
- 1/ASA more than II
- 2/Patients with known allergy to study drugs
- 3/Skin infection at site of needle puncture
- 4/Coagulopathy
- 5/Uncooperative patients
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Adding Morphine as an Adjuvant to Local Anesthetic in Erector Spinae Plane Block on Management of Acute Post Mastectomy Pain : A Randomized Controlled Trial
The aim of the study is to determine the efficacy of adding morphine in two doses (3mg, 5mg) to erector spinae plane block in relieving acute post mastectomy pain
Read the detailed description
Breast cancer is the most common cancer in women requiring surgery . Breast surgeries is one of the most common type of surgery performed worldwide . Of these patients 30% to 50% will report moderate to severe acute pain. Pain if underestimated and untreated will affect patient's recovery , hemostasis, and lead to delayed discharge from PACU and increase length of hospital stay.Variety of local and regional anesthetic procedures which include local anesthetic infiltration , field block , intercostal nerve block , brachial plexus block and thoracic epidural anesthesia for breast surgery have considard as well established option to provide analgesia ,reduce post operative pain score , reduce opioid requirement , decrease post operative nausea and vomiting ,decrease pulmonary complication and duration of stay in PACU and specific to breast surgery there is also some evidence that regional anesthesia may help attenuate the surgical stress response and indirectly contribute to tumor inhibition by reducing opioid usage which has been implicated in immunosuppression and cancer progression. Pectoralis nerve block , serratus anterior nerve block and paravertebral nerve block are used for breast surgery analgesia . pectoralis nerve block and paravertebral block entrenched in clinical practice , and both of these techniques are shown to be effective as analgesic after breast surgery . However these techniques have many drawbacks . For example after performing the pectoralis nerve block the spread of the local anesthetic may interfere with surgical field . Paravertebral block can cause pneumothorax and epidural or intra thecal injection of the local anesthetic. Erector spinae plane block (ESPB) is a relatively new technique that was first described by Forero et Al in 2016 , they found that administration of local anesthetic below the erector spinae muscle produce extensive sensory block over the ipsilateral thorax . Forero et Al proposed that the injected local anesthetic spread anteriorly through the costo transverse foramen to its site of action at the origin of dorsal and ventral rami .Various adjuvants such as morphine , clonidine ,fentanyl, dexamethasone ,epinephrine ,and dexemedetomidine have been used with local anesthetic for improving and prolonging the postoperative analgesia with encouraging result . Morphine is a potent opioid analgesic widely used for treatment of severe pain. sedation scales assess the level of consciousness through behavioral observation and/ or stimulation of the patient. Ramsay sedation scale classifies level of awareness into six categories, this scale has multiple advantages :it is reproducible ,easy executed and has good applicability. This has made the scale the most widely used to assess level of sedation .Several rating scales have been developed to measure quality of recovery after surgery and anaesthesia, but the most extensively used after surgery is the QoR-40 scale,a40-item questionnaire that provide a global score and subscore across five dimension :patient support, comfort, emotion, physical independence, and pain.
- Conditions
- Acute Post-mastectomy Pain Treatment
- Being tested
- erector spinae plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erector spinae plane blockProcedure or surgery
The ultrasound (US)-guided ESP block will be provided while the patient be in a seated position according to surgical site (right or left). Using high-frequency linear US transducer , the probe is placed in the longitudinal orientation lateral to thoracic third and six spinous processes ,then the trapezius muscle ,rhomboids major muscle and erector spinae muscle are identified and we will inject 20ml of 0.25% bupivacaine into interfacial plane below erector spinae muscle in one level (between T3and T6) ,alone in 1st group,with 3 mg morphine in 2nd group and 5 mg morphine in 3rd group
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | this group will receive erector spinae plane block only(bupivicaine) Receives: Procedure: erector spinae plane block |
| Interventional 3mg | Experimental | this group will receive erector spinae plane block (bupivicaine and 3mg morphine) Receives: Procedure: erector spinae plane block |
| Interventional 5mg | Experimental | this group will receive erector spinae plane block (bupivicaine and 5mg morphine) Receives: Procedure: erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
total morphine consumption
. If the VAS score more than 3 rescue postoperative analgesia in the form of PCA morphine with initial bolus of 0.1mg/kg will be administered once the patient exhibit pain , followed by a 1 mg bolus with a locked period of 15 minutes when no background infusion will be permitted, total amount of morphine will be consumed be the patient will be recorded.
Measured: during 24 hours post operative
Secondary outcomes (7)
Time of first analgesic request
time when the patient ask for analgesia post operative will be recorded
Measured: 2,4,6,8,12,24 hours post operative
VAS at rest and movement
the visual analoge scale(VAS) which was scored from 0 to 10 where 0 = no pain and 10= the worst pain imaginable,
Measured: 2,4,6,8,12,24 hours post operative
Mean blood pressure (MBP)
Measured: Pre operative,intra operative and post operative at 2,4,6,8,12,24 hours post operative
Number of participants with morphine side effects
Measured: 2,4,6,8,12,24 hours post operative
Ramsay sedation scale
Scale range from 1 (awake and alert) to 8 (unresponsive to external stimuli including pain)
Measured: 2,4,6,8,12,24 hours post operative
Quality of recovery scale (QoR40)
From 1 to 5, where 1=very poor and 5= excellent
Measured: at 24 hours post operative
Heart rate (HR)
Measured: Pre operative,intra operative and post operative at 2,4,6,8,12,24 hours post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study startSep 2024 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Acute Post-mastectomy Pain TreatmentStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadir atef, Assiut University
- Investigators
- shereen Mamdouh, Study director, south Egypt cancer institute ,Assiut university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175741
- Sponsor's protocol ID
- ESP block with morphine in PMP
- Status last verified
- Jun 2024
- First submitted
- 30 Nov 2023
- Last updated
- 6 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Poleshuck EL, Katz J, Andrus CH, Hogan LA, Jung BF, Kulick DI, Dworkin RH. Risk factors for chronic pain following breast cancer surgery: a prospective study. J Pain. 2006 Sep;7(9):626-34. doi: 10.1016/j.jpain.2006.02.007.
PubMed 16942948Fecho K, Miller NR, Merritt SA, Klauber-Demore N, Hultman CS, Blau WS. Acute and persistent postoperative pain after breast surgery. Pain Med. 2009 May-Jun;10(4):708-15. doi: 10.1111/j.1526-4637.2009.00611.x. Epub 2009 Apr 22.
PubMed 19453965Joshi GP, Ogunnaike BO. Consequences of inadequate postoperative pain relief and chronic persistent postoperative pain. Anesthesiol Clin North Am. 2005 Mar;23(1):21-36. doi: 10.1016/j.atc.2004.11.013.
PubMed 15763409Weltz CR, Greengrass RA, Lyerly HK. Ambulatory surgical management of breast carcinoma using paravertebral block. Ann Surg. 1995 Jul;222(1):19-26. doi: 10.1097/00000658-199507000-00004.
PubMed 7618963Sekandarzad MW, van Zundert AAJ, Lirk PB, Doornebal CW, Hollmann MW. Perioperative Anesthesia Care and Tumor Progression. Anesth Analg. 2017 May;124(5):1697-1708. doi: 10.1213/ANE.0000000000001652.
PubMed 27828796Cali Cassi L, Biffoli F, Francesconi D, Petrella G, Buonomo O. Anesthesia and analgesia in breast surgery: the benefits of peripheral nerve block. Eur Rev Med Pharmacol Sci. 2017 Mar;21(6):1341-1345.
PubMed 28387892Zhao J, Han F, Yang Y, Li H, Li Z. Pectoral nerve block in anesthesia for modified radical mastectomy: A meta-analysis based on randomized controlled trials. Medicine (Baltimore). 2019 May;98(18):e15423. doi: 10.1097/MD.0000000000015423.
PubMed 31045802Bakshi SG, Karan N, Parmar V. Pectoralis block for breast surgery: A surgical concern? Indian J Anaesth. 2017 Oct;61(10):851-852. doi: 10.4103/ija.IJA_455_17. No abstract available.
PubMed 29242663Naja Z, Lonnqvist PA. Somatic paravertebral nerve blockade. Incidence of failed block and complications. Anaesthesia. 2001 Dec;56(12):1184-8. doi: 10.1046/j.1365-2044.2001.02084-2.x.
PubMed 11736777Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
PubMed 27501016El Mourad MB, Amer AF. Effects of adding dexamethasone or ketamine to bupivacaine for ultrasound-guided thoracic paravertebral block in patients undergoing modified radical mastectomy: A prospective randomized controlled study. Indian J Anaesth. 2018 Apr;62(4):285-291. doi: 10.4103/ija.IJA_791_17.
PubMed 29720754Hassan ME, Mahran E. Evaluation of the role of dexmedetomidine in improvement of the analgesic profile of thoracic paravertebral block in thoracic surgeries: A randomised prospective clinical trial. Indian J Anaesth. 2017 Oct;61(10):826-831. doi: 10.4103/ija.IJA_221_17.
PubMed 29242655Lozano-Diaz D, Valdivielso Serna A, Garrido Palomo R, Arias-Arias A, Tarraga Lopez PJ, Martinez Gutierrez A. Validation of the Ramsay scale for invasive procedures under deep sedation in pediatrics. Paediatr Anaesth. 2021 Oct;31(10):1097-1104. doi: 10.1111/pan.14248. Epub 2021 Jul 11.
PubMed 34173295Herrera FJ, Wong J, Chung F. A systematic review of postoperative recovery outcomes measurements after ambulatory surgery. Anesth Analg. 2007 Jul;105(1):63-9. doi: 10.1213/01.ane.0000265534.73169.95.
PubMed 17578958
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adding Morphine as an Adjuvant to Local Anesthetic in Erector Spinae Plane Block on Management of Acute Post Mastectomy Pain : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06175741
- Acronym / sponsor ID
- ESP block with morphine in PMP
- Conditions
- Acute Post-mastectomy Pain Treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 19 Dec 2023 (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 aim of the study is to determine the efficacy of adding morphine in two doses (3mg, 5mg) to erector spinae plane block in relieving acute post mastectomy pain
Detailed description
Breast cancer is the most common cancer in women requiring surgery . Breast surgeries is one of the most common type of surgery performed worldwide . Of these patients 30% to 50% will report moderate to severe acute pain. Pain if underestimated and untreated will affect patient's recovery , hemostasis, and lead to delayed discharge from PACU and increase length of hospital stay.Variety of local and regional anesthetic procedures which include local anesthetic infiltration , field block , intercostal nerve block , brachial plexus block and thoracic epidural anesthesia for breast surgery have considard as well established option to provide analgesia ,reduce post operative pain score , reduce opioid requirement , decrease post operative nausea and vomiting ,decrease pulmonary complication and duration of stay in PACU and specific to breast surgery there is also some evidence that regional anesthesia may help attenuate the surgical stress response and indirectly contribute to tumor inhibition by reducing opioid usage which has been implicated in immunosuppression and cancer progression. Pectoralis nerve block , serratus anterior nerve block and paravertebral nerve block are used for breast surgery analgesia . pectoralis nerve block and paravertebral block entrenched in clinical practice , and both of these techniques are shown to be effective as analgesic after breast surgery . However these techniques have many drawbacks . For example after performing the pectoralis nerve block the spread of the local anesthetic may interfere with surgical field . Paravertebral block can cause pneumothorax and epidural or intra thecal injection of the local anesthetic. Erector spinae plane block (ESPB) is a relatively new technique that was first described by Forero et Al in 2016 , they found that administration of local anesthetic below the erector spinae muscle produce extensive sensory block over the ipsilateral thorax . Forero et Al proposed that the injected local anesthetic spread anteriorly through the costo transverse foramen to its site of action at the origin of dorsal and ventral rami .Various adjuvants such as morphine , clonidine ,fentanyl, dexamethasone ,epinephrine ,and dexemedetomidine have been used with local anesthetic for improving and prolonging the postoperative analgesia with encouraging result . Morphine is a potent opioid analgesic widely used for treatment of severe pain. sedation scales assess the level of consciousness through behavioral observation and/ or stimulation of the patient. Ramsay sedation scale classifies level of awareness into six categories, this scale has multiple advantages :it is reproducible ,easy executed and has good applicability. This has made the scale the most widely used to assess level of sedation .Several rating scales have been developed to measure quality of recovery after surgery and anaesthesia, but the most extensively used after surgery is the QoR-40 scale,a40-item questionnaire that provide a global score and subscore across five dimension :patient support, comfort, emotion, physical independence, and pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Procedure: erector spinae plane blockthis group will receive erector spinae plane block only(bupivicaine) |
| Interventional 3mg | Experimental | Procedure: erector spinae plane blockthis group will receive erector spinae plane block (bupivicaine and 3mg morphine) |
| Interventional 5mg | Experimental | Procedure: erector spinae plane blockthis group will receive erector spinae plane block (bupivicaine and 5mg morphine) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 1/female patients aged from 18 to 60 years.
- 2/ASA I -II
- 3/Surgery is modified radical mastectomy
Key exclusion criteria (5 listed)
- 1/ASA more than II
- 2/Patients with known allergy to study drugs
- 3/Skin infection at site of needle puncture
- 4/Coagulopathy
- 5/Uncooperative patients
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 |
|---|---|---|
| erector spinae plane blockThe ultrasound (US)-guided ESP block will be provided while the patient be in a seated position according to surgical site (right or left). Using high-frequency linear US transducer , the probe is placed in the longitudinal orientation lateral to thoracic third and six spinous processes ,then the trapezius muscle ,rhomboids major muscle and erector spinae muscle are identified and we will inject 20ml of 0.25% bupivacaine into interfacial plane below erector spinae muscle in one level (between T3and T6) ,alone in 1st group,with 3 mg morphine in 2nd group and 5 mg morphine in 3rd group | Procedure or surgery | Control group, Interventional 3mg, Interventional 5mg |
Primary outcome
total morphine consumption
Time frame: during 24 hours post operative
. If the VAS score more than 3 rescue postoperative analgesia in the form of PCA morphine with initial bolus of 0.1mg/kg will be administered once the patient exhibit pain , followed by a 1 mg bolus with a locked period of 15 minutes when no background infusion will be permitted, total amount of morphine will be consumed be the patient will be recorded.
7 secondary outcomes
Time of first analgesic request
Time frame: 2,4,6,8,12,24 hours post operative
VAS at rest and movement
Time frame: 2,4,6,8,12,24 hours post operative
Mean blood pressure (MBP)
Time frame: Pre operative,intra operative and post operative at 2,4,6,8,12,24 hours post operative
Number of participants with morphine side effects
Time frame: 2,4,6,8,12,24 hours post operative
Ramsay sedation scale
Time frame: 2,4,6,8,12,24 hours post operative
Quality of recovery scale (QoR40)
Time frame: at 24 hours post operative
Heart rate (HR)
Time frame: Pre operative,intra operative and post operative at 2,4,6,8,12,24 hours post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Background: PubMed 16942948Poleshuck EL, Katz J, Andrus CH, Hogan LA, Jung BF, Kulick DI, Dworkin RH. Risk factors for chronic pain following breast cancer surgery: a prospective study. J Pain. 2006 Sep;7(9):626-34. doi: 10.1016/j.jpain.2006.02.007.
- Background: PubMed 19453965Fecho K, Miller NR, Merritt SA, Klauber-Demore N, Hultman CS, Blau WS. Acute and persistent postoperative pain after breast surgery. Pain Med. 2009 May-Jun;10(4):708-15. doi: 10.1111/j.1526-4637.2009.00611.x. Epub 2009 Apr 22.
- Background: PubMed 15763409Joshi GP, Ogunnaike BO. Consequences of inadequate postoperative pain relief and chronic persistent postoperative pain. Anesthesiol Clin North Am. 2005 Mar;23(1):21-36. doi: 10.1016/j.atc.2004.11.013.
- Background: PubMed 7618963Weltz CR, Greengrass RA, Lyerly HK. Ambulatory surgical management of breast carcinoma using paravertebral block. Ann Surg. 1995 Jul;222(1):19-26. doi: 10.1097/00000658-199507000-00004.
- Background: PubMed 27828796Sekandarzad MW, van Zundert AAJ, Lirk PB, Doornebal CW, Hollmann MW. Perioperative Anesthesia Care and Tumor Progression. Anesth Analg. 2017 May;124(5):1697-1708. doi: 10.1213/ANE.0000000000001652.
- Background: PubMed 28387892Cali Cassi L, Biffoli F, Francesconi D, Petrella G, Buonomo O. Anesthesia and analgesia in breast surgery: the benefits of peripheral nerve block. Eur Rev Med Pharmacol Sci. 2017 Mar;21(6):1341-1345.
- Background: PubMed 31045802Zhao J, Han F, Yang Y, Li H, Li Z. Pectoral nerve block in anesthesia for modified radical mastectomy: A meta-analysis based on randomized controlled trials. Medicine (Baltimore). 2019 May;98(18):e15423. doi: 10.1097/MD.0000000000015423.
- Background: PubMed 29242663Bakshi SG, Karan N, Parmar V. Pectoralis block for breast surgery: A surgical concern? Indian J Anaesth. 2017 Oct;61(10):851-852. doi: 10.4103/ija.IJA_455_17. No abstract available.
- Background: PubMed 11736777Naja Z, Lonnqvist PA. Somatic paravertebral nerve blockade. Incidence of failed block and complications. Anaesthesia. 2001 Dec;56(12):1184-8. doi: 10.1046/j.1365-2044.2001.02084-2.x.
- Background: PubMed 27501016Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
- Background: PubMed 29720754El Mourad MB, Amer AF. Effects of adding dexamethasone or ketamine to bupivacaine for ultrasound-guided thoracic paravertebral block in patients undergoing modified radical mastectomy: A prospective randomized controlled study. Indian J Anaesth. 2018 Apr;62(4):285-291. doi: 10.4103/ija.IJA_791_17.
- Background: PubMed 29242655Hassan ME, Mahran E. Evaluation of the role of dexmedetomidine in improvement of the analgesic profile of thoracic paravertebral block in thoracic surgeries: A randomised prospective clinical trial. Indian J Anaesth. 2017 Oct;61(10):826-831. doi: 10.4103/ija.IJA_221_17.
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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.
shereen Mamdouh study director
south Egypt cancer institute ,Assiut university
Questions about this trial
What is this clinical trial studying?
A study testing erector spinae plane block in people with Acute Post-mastectomy Pain Treatment, run by Assiut University.
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 5 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: status not confirmed, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hadir Atef (+201060176410, hadeer.200atef@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total morphine consumption (time frame: during 24 hours post operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06175741, which also lists 14 linked publications.
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 6 Jun 2024.