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

Study Overview
=================
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.

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

Conditions
-----------------
Local Anesthetic, Ultrasound, Pain, Acute

Intervention / Treatment
-----------------
* Drug: TAPB with dexamethasone as an adjuvant to local anesthetics
* Drug: TAPB with methylprednisolone as an adjuvant to local anesthetics


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model 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).
Masking: Double


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ultrasound, TAP block, Hystrectomy, methyl prednisolone