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

Primary Purpose

Post Operative Pain

Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Ultrasound Guided Erector Spinae Plane Block
Intrathecal morphine
General anesthesia using intravenous fentanyl (1µg/kg)
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Operative Pain

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ain-Shams University HospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Other

Arm Label

General anesthesia and Ultrasound Guided Erector Spinae Plane Block

General anesthesia and intrathecal morphine

General anesthesia using intravenous fentanyl (1µg/kg)

Arm Description

Outcomes

Primary Outcome Measures

Time to first requested rescue analgesia (Minutes).
Time to first requested rescue analgesia (Minutes).

Secondary Outcome Measures

Full Information

First Posted
April 14, 2022
Last Updated
July 20, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05338320
Brief Title
Postoperative Analgesia in Patients Undergoing Elective Lumbar Fusion Operations Under General Anesthesia
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
General anesthesia and Ultrasound Guided Erector Spinae Plane Block
Arm Type
Active Comparator
Arm Title
General anesthesia and intrathecal morphine
Arm Type
Active Comparator
Arm Title
General anesthesia using intravenous fentanyl (1µg/kg)
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Ultrasound Guided Erector Spinae Plane Block
Intervention Description
General anesthesia and Ultrasound Guided Erector Spinae Plane Block
Intervention Type
Drug
Intervention Name(s)
Intrathecal morphine
Intervention Description
General anesthesia and intrathecal morphine
Intervention Type
Other
Intervention Name(s)
General anesthesia using intravenous fentanyl (1µg/kg)
Intervention Description
General anesthesia using intravenous fentanyl (1µg/kg)
Primary Outcome Measure Information:
Title
Time to first requested rescue analgesia (Minutes).
Description
Time to first requested rescue analgesia (Minutes).
Time Frame
First 24 hours after surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ibrahim Mamdouh Esmat
Phone
01001241928
Email
ibrahim_mamdouh@med.asu.edu.eg
Facility Information:
Facility Name
Ain-Shams University Hospitals
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ibrahim Mamdouh Esmat
Email
ibrahim_mamdouh@med.asu.edu.eg

12. IPD Sharing Statement

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

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