Adding Morphine to ESP Block in Management of Acute PMP

NCT ID: NCT06175741

Last Updated: 2024-06-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2026-03-31

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.

Conditions

Acute Post-mastectomy Pain Treatment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Control group

this group will receive erector spinae plane block only(bupivicaine)

Group Type: PLACEBO_COMPARATOR

erector spinae plane block

Intervention Type: PROCEDURE

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

Interventional 3mg

this group will receive erector spinae plane block (bupivicaine and 3mg morphine)

Group Type: EXPERIMENTAL

erector spinae plane block

Intervention Type: PROCEDURE

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

Interventional 5mg

this group will receive erector spinae plane block (bupivicaine and 5mg morphine)

Group Type: EXPERIMENTAL

erector spinae plane block

Intervention Type: PROCEDURE

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

Interventions

erector spinae plane block

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Hadir atef

Principal invistigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

shereen Mamdouh

Role: STUDY_DIRECTOR

south Egypt cancer institute ,Assiut university

Central Contacts

Hadir Atef

Role: CONTACT

hadeer.200atef@gmail.com

+201060176410

References

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Other Identifiers

ESP block with morphine in PMP

Identifier Type: -

Identifier Source: org_study_id