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

Pain, Acute Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06131593
• Other study ID #: N-139-2023
• Status: Completed
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: April 20, 2024

Study information

• Verified date: April 2024
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 20, 2024
• Est. primary completion date: April 20, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Local Anesthetic
• Pain, Acute
• Ultrasound

Intervention

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

Locations

Country	Name	City	State
Egypt	Cairo university hospitals, kasralainy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to first analgesic request of rescue analgesia	Time to first analgesic request of nalbuphine as a rescue analgesia	24 hours
Secondary	Total consumption of Nalbuphine in 1st 24 hours	Total consumption of Nalbuphine in 1st 24 hours	24 hours