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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06131593
Enrollment
50
Registered
2023-11-14
Start date
2023-12-01
Completion date
2024-04-20
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Local Anesthetic, Pain, Acute, Ultrasound

Keywords

ultrasound, TAP block, Hystrectomy, methyl prednisolone

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.

Interventions

DRUGTAPB with dexamethasone as an adjuvant to local anesthetics

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

DRUGTAPB with methylprednisolone as an adjuvant to local anesthetics

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

Sponsors

Kasr El Aini Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

The patient and assessing study outcomes will be blinded to the study group allocation.

Intervention 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).

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
postoperative pain score by Visual analogue score at 48 hrs.48 hourspostoperative 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)

Secondary

MeasureTime frameDescription
Time to first analgesic request of rescue analgesia24 hoursTime to first analgesic request of nalbuphine as a rescue analgesia
Total consumption of Nalbuphine in 1st 24 hours24 hoursTotal consumption of Nalbuphine in 1st 24 hours

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026