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Adding Morphine to ESP Block in Management of Acute PMP

A

Assiut University

Status

Not yet enrolling

Conditions

Acute Post-mastectomy Pain Treatment

Treatments

Procedure: erector spinae plane block

Study type

Interventional

Funder types

Other

Identifiers

NCT06175741
ESP block with morphine in PMP

Details and patient eligibility

About

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

Full 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.

Enrollment

60 estimated patients

Sex

Female

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

60 participants in 3 patient groups, including a placebo group

Control group
Placebo Comparator group
Description:
this group will receive erector spinae plane block only(bupivicaine)
Treatment:
Procedure: erector spinae plane block
Interventional 3mg
Experimental group
Description:
this group will receive erector spinae plane block (bupivicaine and 3mg morphine)
Treatment:
Procedure: erector spinae plane block
Interventional 5mg
Experimental group
Description:
this group will receive erector spinae plane block (bupivicaine and 5mg morphine)
Treatment:
Procedure: erector spinae plane block

Trial contacts and locations

0

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Central trial contact

Hadir Atef

Data sourced from clinicaltrials.gov

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