TAP Block With Methyl-prednisolone as a Pain Treatment Modality After Total Abdominal Hysterectomy Procedures

NCT06131593 | Completed

• 1 other identifier: N-139-2023
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this work to compare between the efficacy of ultrasound guided TAP block with dexamethasone as an adjuvant versus ultrasound guided TAPB with methyl prednisolone as an adjuvant to local anesthetic for postoperative pain management in lower abdominal hysterectomy procedures.

Conditions

Local Anesthetic; Ultrasound; Pain, Acute

Keywords

ultrasound; TAP block; Hystrectomy; methyl prednisolone

Outcome Measures

Primary Outcomes (1)

• postoperative pain score by Visual analogue score at 48 hrs.

  postoperative pain score by Visual analogue score at 48 hours Post operative pain assessment using Visual analogue score which is numerical score from (0-10) (zero refer to no pain and 10 refer to the worst pain)

  48 hours

Secondary Outcomes (2)

• Time to first analgesic request of rescue analgesia

  24 hours

• Total consumption of Nalbuphine in 1st 24 hours

  24 hours

Study Arms (2)

Group TAPB-D (n=25)

EXPERIMENTAL

Patients in this group will receive TAPB with dexamethasone as an adjuvant to local anesthetic.

Drug: TAPB with dexamethasone as an adjuvant to local anesthetics

Group TAPB-M (n=25)

ACTIVE COMPARATOR

Patients in this group will receive TAPB with methylprednisolone as an adjuvant to local anesthetic.

Drug: TAPB with methylprednisolone as an adjuvant to local anesthetics

Interventions

TAPB with dexamethasone as an adjuvant to local anesthetics DRUG

patients will receive TAPB with dexamethasone as an adjuvant to bupivacaine and lidocaine local anesthetics

Group TAPB-D (n=25)

TAPB with methylprednisolone as an adjuvant to local anesthetics DRUG

patients will receive TAPB with methylprednisolone as an adjuvant to bupivacaine and lidocaine local anesthetics

Group TAPB-M (n=25)

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA physical status I-II.
• Age 20-45 years.
• Undergoing lower abdominal hysterectomies.

You may not qualify if:

• Patient refusal
• Patients with coagulopathy.
• Hypertensive patients.
• Diabetic patients.
• Morbid obesity
• Allergy to the used drugs

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Cairo university hospitals, kasralainy

Cairo, 11559, Egypt

Location

MeSH Terms

Conditions

Acute Pain

Interventions

1,3-bis(4-amidinophenoxy)-2-(4-amidinophenoxymethyl)ethylpropane; Dexamethasone; Methylprednisolone

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Prednisolone

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient and assessing study outcomes will be blinded to the study group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator, Asst. professor of anesthesia, Cairo university

Model Details: Patients will be divided in to two groups; TAPB with dexamethasone as an adjuvant to local anesthetic Gr A(n=25) and TAPB with methyl prednisolone as an adjuvant to local anesthetic Gr B(n=25).

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 14, 2023
• Study Start: December 1, 2023
• Primary Completion: April 20, 2024
• Study Completion: April 20, 2024
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)