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

K

Kasr El Aini Hospital

Status

Completed

Conditions

Local Anesthetic
Pain, Acute
Ultrasound

Treatments

Drug: TAPB with dexamethasone as an adjuvant to local anesthetics
Drug: TAPB with methylprednisolone as an adjuvant to local anesthetics

Study type

Interventional

Funder types

Other

Identifiers

NCT06131593
N-139-2023

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

Female

Ages

20 to 45 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 2 patient groups

Group TAPB-D (n=25)
Experimental group
Description:
Patients in this group will receive TAPB with dexamethasone as an adjuvant to local anesthetic.
Treatment:
Drug: TAPB with dexamethasone as an adjuvant to local anesthetics
Group TAPB-M (n=25)
Active Comparator group
Description:
Patients in this group will receive TAPB with methylprednisolone as an adjuvant to local anesthetic.
Treatment:
Drug: TAPB with methylprednisolone as an adjuvant to local anesthetics

Trial contacts and locations

1

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Central trial contact

Khaled Sarhan, MD; Dina Turki, MD

Data sourced from clinicaltrials.gov

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