Adding Morphine to ESP Block in Management of Acute PMP

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Acute Post-mastectomy Pain Treatment

Intervention / Treatment
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* Procedure: erector spinae plane block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1/female patients aged from 18 to 60 years. 2/ASA I -II 3/Surgery is modified radical mastectomy Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>this group will receive erector spinae plane block only(bupivicaine) | Procedure: erector spinae plane block<br>* 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 three levels (T3,T4 and T6) ,alone in 1st group,with 3 mg morphine in 2nd group and 5 mg morphine in 3rd group<br>|
| Experimental: Interventional 3mg<br>this group will receive erector spinae plane block (bupivicaine and 3mg morphine) | Procedure: erector spinae plane block<br>* 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 three levels (T3,T4 and T6) ,alone in 1st group,with 3 mg morphine in 2nd group and 5 mg morphine in 3rd group<br>|
| Experimental: Interventional 5mg<br>this group will receive erector spinae plane block (bupivicaine and 5mg morphine) | Procedure: erector spinae plane block<br>* 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 three levels (T3,T4 and T6) ,alone in 1st group,with 3 mg morphine in 2nd group and 5 mg morphine in 3rd group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | during 24 hours post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of first analgesic request | time when the patient ask for analgesia post operative will be recorded | 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, | 2,4,6,8,12,24 hours post operative | 
| Mean blood pressure (MBP) |  | Pre operative,intra operative and post operative at 2,4,6,8,12,24 hours post operative | 
| Number of participants with morphine side effects |  | 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) | 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 | at 24 hours post operative | 
| Heart rate (HR) |  | Pre operative,intra operative and post operative at 2,4,6,8,12,24 hours post operative |