Ultrasound Guided Erector Spinae Plane Block vs Intrathecal Morphine

Post Operative Pain Clinical Trial

Official title:

Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy: A Randomized Controlled Comparison Between Ultrasound Guided Erector Spinae Plane Block and Intrathecal Morphine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05218733
• Other study ID #: IRB 00006379//31-1-2022
• Status: Completed
• Phase: Phase 4
• Start date: February 15, 2022
• Est. completion date: September 20, 2023

Study information

• Verified date: October 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 20, 2023
• Est. primary completion date: September 20, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Procedure:
• Ultrasound Guided Erector Spinae Plane Block
General anesthesia using intravenous fentanyl (1µgm/kg) and patients will receive bilateral ultrasound-guided ESPB by the an experienced anesthetist in US regional blocks, with each block 20 mL of bupivacaine 0.25%

Drug:
• Intra thecal morphine.
General anesthesia using intravenous fentanyl (1µgm/kg) and patients will receive intra thecal morphine with spinal needle 25G, 3 ml containing 300 ug preservative free morphine
• General anesthesia using intravenous fentanyl (1µgm/kg)
Patients will receive general anesthesia using intravenous fentanyl (1µgm/kg)

Locations

Country	Name	City	State
Egypt	Ain-Shams University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The time for requirement of first rescue analgesic (min)	The time for requirement of first rescue analgesic (min)	24 hours postoperatively