Postoperative Analgesia in Patients Undergoing Elective Lumbar Fusion Operations Under General Anesthesia

January 31, 2024 updated by: Ibrahim Mamdouh Esmat, Ain Shams University

A Randomized Controlled Trial for Postoperative Analgesia in Patients Undergoing Elective Lumbar Fusion Operations Under General Anesthesia: Ultrasound Guided Erector Spinae Plane Block Versus Intrathecal Morphine

It was proven that intrathecal opioids are considered as an effective means of pain control in several major surgical interventions including spine surgeries. Intrathecal morphine added to a spinal anesthesia reduces acute pain after spine surgeries but has side effects, including dose dependent respiratory depression, nausea, vomiting, pruritus, and sedation. Ultrasound guided Erector Spinae Plane Block (ESPB) was first described in 2016.Recent case reports suggest a positive effect of ultrasound guided ESPB on pain for multiple indications including lumbar spine fusion and scoliosis surgery, with a very low risk of complications as there are no structures in close proximity at risk of needle injury.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

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

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

21 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Body mass index (BMI) 25 to 35 kg/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: General anesthesia and Ultrasound Guided Erector Spinae Plane Block
Procedure: Ultrasound Guided Erector Spinae Plane Block
General anesthesia and Ultrasound Guided Erector Spinae Plane Block
Active Comparator: General anesthesia and intrathecal morphine
Drug: Intrathecal morphine
General anesthesia and intrathecal morphine
Other: General anesthesia using intravenous fentanyl (1µg/kg)
Other: General anesthesia using intravenous fentanyl (1µg/kg)
General anesthesia using intravenous fentanyl (1µg/kg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first requested rescue analgesia (Minutes).
Time Frame: First 24 hours after surgery.
Time to first requested rescue analgesia (Minutes).
First 24 hours after surgery.

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)

May 10, 2022

Primary Completion (Estimated)

March 31, 2024

Study Completion (Estimated)

March 31, 2024

Study Registration Dates

First Submitted

April 14, 2022

First Submitted That Met QC Criteria

April 14, 2022

First Posted (Actual)

April 21, 2022

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU MD 102/2022

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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Locations

3
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