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

NCT ID: NCT06131593

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-04-20

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.

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.

Conditions

Local Anesthetic; Ultrasound; Pain, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group TAPB-D (n=25)

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

Group Type: EXPERIMENTAL

TAPB with dexamethasone as an adjuvant to local anesthetics

Intervention Type: DRUG

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

Group TAPB-M (n=25)

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

Group Type: ACTIVE_COMPARATOR

TAPB with methylprednisolone as an adjuvant to local anesthetics

Intervention Type: DRUG

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

Interventions

TAPB with dexamethasone as an adjuvant to local anesthetics

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

Khaled Abdelfattah Abdallah Sarhan

principal investigator, Asst. professor of anesthesia, Cairo university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo university hospitals, kasralainy

Cairo, , Egypt

Countries

Egypt

Other Identifiers

N-139-2023

Identifier Type: -

Identifier Source: org_study_id