Ultrasound Guided Erector Spinae Plane Block vs Intrathecal Morphine

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Post Operative Pain

Treatments: Procedure: Ultrasound Guided Erector Spinae Plane Block; Drug: General anesthesia using intravenous fentanyl (1µgm/kg); Drug: Intra thecal morphine.

Study type: Interventional

Funder types: Other

Identifiers

NCT05218733

IRB 00006379//31-1-2022

Details and patient eligibility

About

Total abdominal hysterectomy (TAH) is a major surgical procedure after which significant post-operative pain and discomfort are anticipated. Abdominal field blocks have been followed for many years and extensively used for pain management following abdominal surgeries such as laparotomies and appendicectomies. Erector Spinae Plane Block (ESPB)-first recently described for the treatment of thoracic neuropathic pain, is a peri-paravertebral regional anesthesia technique that has since been reported as an effective technique for prevention of postoperative pain in various surgeries. Intrathecal opioid administration is an attractive analgesic technique since the opioid is injected directly into the cerebrospinal fluid, close to the structures of the central nervous system where the opioid acts.

Enrollment: 120 patients

Sex: Female

Ages: 40 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Body mass index (BMI) 25 to 35kg/m².
• American Society of Anesthesiologist (ASA) physical status I or II.

Exclusion criteria

• patient's refusal
• Altered mental status
• Known allergy to study drugs (bupivacaine or morphine)
• Local infection at site of puncture.
• Known case with any pulmonary disease
• Known case with Obstructive sleep apnea (OSA)
• Coagulopathy and /or thrombocytopenia
• Chronic pain
• Severe hepatic or kidney impairment

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups

G1 Group: (Erector Spinae Plane Block (ESPB) Group)

Active Comparator group

Treatment:

Procedure: Ultrasound Guided Erector Spinae Plane Block

G2 Group: (Intra thecal morphine (ITM) Group)

Active Comparator group

Treatment:

Drug: Intra thecal morphine.

G3 Group: (Control Group)

Other group

Treatment:

Drug: General anesthesia using intravenous fentanyl (1µgm/kg)