Ultrasound Guided Erector Spinae Plane Block vs Intrathecal Morphine

October 1, 2023 updated by: Ibrahim Mamdouh Esmat, Ain Shams University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain-Shams University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: G1 Group: (Erector Spinae Plane Block (ESPB) Group)
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%
Active Comparator: G2 Group: (Intra thecal morphine (ITM) Group)
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
Other: G3 Group: (Control Group)
Drug: General anesthesia using intravenous fentanyl (1µgm/kg)
Patients will receive general anesthesia using intravenous fentanyl (1µgm/kg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The time for requirement of first rescue analgesic (min)
Time Frame: 24 hours postoperatively
The time for requirement of first rescue analgesic (min)
24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2022

Primary Completion (Actual)

September 20, 2023

Study Completion (Actual)

September 20, 2023

Study Registration Dates

First Submitted

January 31, 2022

First Submitted That Met QC Criteria

January 31, 2022

First Posted (Actual)

February 1, 2022

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

October 1, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 00006379//31-1-2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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