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Ultrasound Guided Erector Spinae Plane Block vs Intrathecal Morphine

Primary Purpose

Post Operative Pain

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Ultrasound Guided Erector Spinae Plane Block
Intra thecal morphine.
General anesthesia using intravenous fentanyl (1µgm/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

40 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ain-Shams University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Other

Arm Label

G1 Group: (Erector Spinae Plane Block (ESPB) Group)

G2 Group: (Intra thecal morphine (ITM) Group)

G3 Group: (Control Group)

Arm Description

Outcomes

Primary Outcome Measures

The time for requirement of first rescue analgesic (min)
The time for requirement of first rescue analgesic (min)

Secondary Outcome Measures

Full Information

First Posted
January 31, 2022
Last Updated
October 1, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05218733
Brief Title
Ultrasound Guided Erector Spinae Plane Block vs Intrathecal Morphine
Official Title
Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy: A Randomized Controlled Comparison Between Ultrasound Guided Erector Spinae Plane Block and Intrathecal Morphine
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
February 15, 2022 (Actual)
Primary Completion Date
September 20, 2023 (Actual)
Study Completion Date
September 20, 2023 (Actual)

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
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.

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 (Actual)

8. Arms, Groups, and Interventions

Arm Title
G1 Group: (Erector Spinae Plane Block (ESPB) Group)
Arm Type
Active Comparator
Arm Title
G2 Group: (Intra thecal morphine (ITM) Group)
Arm Type
Active Comparator
Arm Title
G3 Group: (Control Group)
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Ultrasound Guided Erector Spinae Plane Block
Intervention Description
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%
Intervention Type
Drug
Intervention Name(s)
Intra thecal morphine.
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
General anesthesia using intravenous fentanyl (1µgm/kg)
Intervention Description
Patients will receive general anesthesia using intravenous fentanyl (1µgm/kg)
Primary Outcome Measure Information:
Title
The time for requirement of first rescue analgesic (min)
Description
The time for requirement of first rescue analgesic (min)
Time Frame
24 hours postoperatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ain-Shams University Hospitals
City
Cairo
Country
Egypt

12. IPD Sharing Statement

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Ultrasound Guided Erector Spinae Plane Block vs Intrathecal Morphine

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