Adding Morphine to ESP Block in Management of Acute PMP
- Conditions
- Acute Post-mastectomy Pain Treatment
- Interventions
- Procedure: erector spinae plane block
- Registration Number
- NCT06175741
- Lead Sponsor
- Assiut University
- Brief 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
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 60
- 1/female patients aged from 18 to 60 years.
- 2/ASA I -II
- 3/Surgery is modified radical mastectomy
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group erector spinae plane block this group will receive erector spinae plane block only(bupivicaine) Interventional 3mg erector spinae plane block this group will receive erector spinae plane block (bupivicaine and 3mg morphine) Interventional 5mg erector spinae plane block this group will receive erector spinae plane block (bupivicaine and 5mg morphine)
- Primary Outcome Measures
Name Time Method total morphine consumption 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.
- Secondary Outcome Measures
Name Time Method Time of first analgesic request 2,4,6,8,12,24 hours post operative time when the patient ask for analgesia post operative will be recorded
Quality of recovery scale (QoR40) at 24 hours post operative From 1 to 5, where 1=very poor and 5= excellent
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 2,4,6,8,12,24 hours post operative Scale range from 1 (awake and alert) to 8 (unresponsive to external stimuli including pain)
Heart rate (HR) Pre operative,intra operative and post operative at 2,4,6,8,12,24 hours post operative VAS at rest and movement 2,4,6,8,12,24 hours post operative the visual analoge scale(VAS) which was scored from 0 to 10 where 0 = no pain and 10= the worst pain imaginable,