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

TAP Block With Dexamethasone Versus TAP Block With Methyl-prednisolone as a Pain Treatment Modality After Total Abdominal Hysterectomy Procedures: Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Pain, Acute; Ultrasound; Local Anesthetic
• Intervention / Treatment: Drug: TAPB with dexamethasone as an adjuvant to local anesthetics; Drug: TAPB with methylprednisolone as an adjuvant to local anesthetics

Detailed Description

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).

By the end of surgery and with the patient in supine position and after covering of surgery site, preparing the skin with povidone iodine, a high frequency (5-10 MHZ) ultrasound probe (S-NerveTM; SonoSite Inc., Bothell, WA, USA) will be placed transversally on abdominal wall between lower costal margin and iliac crest near midline. After identifying the rectus abdominis muscle, we will gradually move the ultrasound probe laterally to identify the transversus abdominis muscle lying posterior to the rectus muscle. A 22 G echogenic needle using the in plane technique will be inserted medially aiming towards the iliac crest, then 30ml total volume of 0.25 plain bupivacaine 1.5mg/kg with lidocaine 1% 3mg/kg with 8mg dexamethasone in group A patients and 30ml total volume of 0.25 plain bupivacaine 1.5mg/kg with lidocaine 1% 3mg/kg with 50 mg methylprednisolone in group B patients.

Vital signs (H.R and non invasive blood pressure) will be recorded at the onset of the block then every 20 min for an hour then every 4hrs for 12 hrs. post operative

Postoperative:

Paracetamol every 8 hours and ketorolac every 12 hours should be given as a part of multimodal analgesia and nalbuphine given as rescue analgesia and included in secondary outcomes

Post-operative assessment and analgesic regimen

Post operative pain assessment using V.A.S will be assessed (0-10) (11) (as zero refer to no pain and 10 refer to the worst pain) after 1h of the block then every 4hrs for 12 hrs. then every 8hrs for 48 hrs then after 72hrs . The patient will be given Paracetamol every 8 hours and ketorolac every 12 hours The time to the first request of rescue post operative analgesic will be recorded, when the patient complain of pain (V.A.S> 3) intravenous nalbuphine 5mg will be given, total dose of nalbuphine will be recorded /24hrs.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Khaled Sarhan, MD; Phone Number: +201020067816; Email: khaled.sarhan@kasralainy.edu.eg
• Study Contact Backup: Name: Dina Turki, MD; Phone Number: +201001018809; Email: dinaabdoturki@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 11559
    • Cairo university hospitals, kasralainy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group TAPB-D (n=25); 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; patients will receive TAPB with dexamethasone as an adjuvant to bupivacaine and lidocaine local anesthetics
Active Comparator: Group TAPB-M (n=25); 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; patients will receive TAPB with methylprednisolone as an adjuvant to bupivacaine and lidocaine local anesthetics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first analgesic request of rescue analgesia	Time to first analgesic request of nalbuphine as a rescue analgesia	24 hours
Total consumption of Nalbuphine in 1st 24 hours	Total consumption of Nalbuphine in 1st 24 hours	24 hours

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): April 20, 2024
• Study Completion (Actual): April 20, 2024

Study Registration Dates

• First Submitted: November 9, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Actual): November 14, 2023

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 21, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: ultrasound; TAP block; Hystrectomy; methyl prednisolone
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Dexamethasone; Methylprednisolone; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: N-139-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No