NCT05218733

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

February 15, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2023

Completed
Last Updated

October 3, 2023

Status Verified

October 1, 2023

Enrollment Period

1.6 years

First QC Date

January 31, 2022

Last Update Submit

October 1, 2023

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

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

    The time for requirement of first rescue analgesic (min)

    24 hours postoperatively

Study Arms (3)

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

ACTIVE COMPARATOR
Procedure: Ultrasound Guided Erector Spinae Plane Block

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

ACTIVE COMPARATOR
Drug: Intra thecal morphine.

G3 Group: (Control Group)

OTHER
Drug: General anesthesia using intravenous fentanyl (1µgm/kg)

Interventions

Ultrasound Guided Erector Spinae Plane BlockPROCEDURE

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%

G1 Group: (Erector Spinae Plane Block (ESPB) Group)
Intra thecal morphine.DRUG

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

G2 Group: (Intra thecal morphine (ITM) Group)
General anesthesia using intravenous fentanyl (1µgm/kg)DRUG

Patients will receive general anesthesia using intravenous fentanyl (1µgm/kg)

G3 Group: (Control Group)

Eligibility Criteria

Age40 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index (BMI) 25 to 35kg/m².
  • American Society of Anesthesiologist (ASA) physical status I or II.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain-Shams University Hospitals

Cairo, Egypt

Location

Related Publications (1)

  • Ashoor TM, Esmat IM, Algendy MA, Mohamed NR, Talaat SM, Rabie AH, Elsayed AM. Comparison of the postoperative analgesic efficacy of the ultrasound-guided erector spinae plane block and intrathecal morphine in patients undergoing total abdominal hysterectomy under general anesthesia: a randomized controlled trial. J Anesth. 2025 Apr;39(2):299-310. doi: 10.1007/s00540-025-03466-1. Epub 2025 Mar 6.

    PMID: 40047853DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain-shams University, Cairo, Egypt.

Study Record Dates

First Submitted

January 31, 2022

First Posted

February 1, 2022

Study Start

February 15, 2022

Primary Completion

September 20, 2023

Study Completion

September 20, 2023

Last Updated

October 3, 2023

Record last verified: 2023-10

Locations

EG(1)