Ultrasound Guided Erector Spinae Plane Block vs Intrathecal Morphine

Phase 4

Completed

• Conditions: Post Operative Pain
• Interventions: Procedure: Ultrasound Guided Erector Spinae Plane Block; Drug: Intra thecal morphine.; Drug: General anesthesia using intravenous fentanyl (1µgm/kg)

• Registration Number: NCT05218733
• Lead Sponsor: Ain Shams University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-31
• Study First Submitted QC: 2022-01-31
• Study First Posted: 2022-02-01
• Study Start: 2022-02-15
• Primary Completion: 2023-09-20
• Study Completion: 2023-09-20
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-01
• Last Update Posted: 2023-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
G1 Group: (Erector Spinae Plane Block (ESPB) Group)	Ultrasound Guided Erector Spinae Plane Block	-
G2 Group: (Intra thecal morphine (ITM) Group)	Intra thecal morphine.	-
G3 Group: (Control Group)	General anesthesia using intravenous fentanyl (1µgm/kg)	-

Primary Outcome Measures

Name	Time	Method
The time for requirement of first rescue analgesic (min)	24 hours postoperatively	The time for requirement of first rescue analgesic (min)

Trial Locations

Locations (1)

Ain-Shams University Hospitals; 🇪🇬 Cairo, Egypt