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

Sponsor
Kasr El Aini Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06131593
Collaborator
(none)
50
1
2
8
6.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: TAPB with dexamethasone as an adjuvant to local anesthetics
  • Drug: TAPB with methylprednisolone as an adjuvant to local anesthetics
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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).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 (Participant, Outcomes Assessor)
Masking Description:
The patient and assessing study outcomes will be blinded to the study group allocation.
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A (n=25)

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

Active Comparator: Group B (n=25)

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

Outcome Measures

Primary Outcome Measures

  1. postoperative pain score by Visual analogue score at 48 hrs. [48 hours]

    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)

Secondary Outcome Measures

  1. Time to first analgesic request of rescue analgesia [24 hours]

    Time to first analgesic request of nalbuphine as a rescue analgesia

  2. Total consumption of Nalbuphine in 1st 24 hours [24 hours]

    Total consumption of Nalbuphine in 1st 24 hours

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cairo university hospitals, kasralainy Cairo Egypt 11559

Sponsors and Collaborators

  • Kasr El Aini Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Khaled Abdelfattah Abdallah Sarhan, principal investigator, Asst. professor of anesthesia, Cairo university, Kasr El Aini Hospital
ClinicalTrials.gov Identifier:
NCT06131593
Other Study ID Numbers:
  • N-139-2023
First Posted:
Nov 14, 2023
Last Update Posted:
Nov 14, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Khaled Abdelfattah Abdallah Sarhan, principal investigator, Asst. professor of anesthesia, Cairo university, Kasr El Aini Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 14, 2023