Magnesium Sulphate Versus Dexamethasone as an Adjuvant to Bupivacaine in TAP Block for Abdominal Hysterectomy

NCT06166108 | Unknown Phase 2 FDA Drug

• 1 other identifier: TAP block in Hysterectomy
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to compare the duration of analgesia obtained by addition of dexamethasone and MgSO4 as adjuvants to bupivacaine in TAP block in patients undergoing Total Abdominal Hysterectomy and to evaluate postoperative analgesic requirements, side effects and level of patient satisfaction.

Conditions

TAP Block

Outcome Measures

Primary Outcomes (1)

• Comparasion of postoperative NRS score for 24 hours between the two groups

  NRS Score: used to assess pain intensity. It is one of the most commonly used pain scales in medicine. The NRS consists of a numeric version of the visual analogue scale. It is a horizontal line with an eleven point numeric range. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible. This scale can be administered verbally. Rescue analgesia will be nalbuphine 0.1 mg/kg IV when the NRS ≥ 4.

  24 hours postoperative

Secondary Outcomes (5)

• Postoperative hemodynamic parameters

  24 hours postoperative

• Time required for the first rescue analgesia

  24 hours postoperative

• Total amount of rescue analgesic consumption during the first 24 hours postoperatively

  24 hours postoperative

• Patient satisfaction score

  24 hours postoperative

• PONV intensity by postoperatively

  24 hours postoperative

Study Arms (2)

Group M "bupivacaine +normal saline +MgSO4"

ACTIVE COMPARATOR

will receive 25 ml volume on each side (20 ml of 0.25% bupivacaine plus 5 ml of normal saline containing 250 mg of MgSO4)

Drug: transversus abdominis plane (TAP) block in Abdominal hysterectomy

Group D "bupivacaine +normal saline +dexamethasone"

ACTIVE COMPARATOR

will receive 25ml volume on each side (20 ml of 0.25% bupivacaine plus 5 ml of normal saline containing 8 mg of dexamethasone)

Drug: transversus abdominis plane (TAP) block in Abdominal hysterectomy

Interventions

transversus abdominis plane (TAP) block in Abdominal hysterectomy DRUG

Comparative evaluation of magnesium sulphate versus dexamethasone as an adjuvant to bupivacaine in ultrasound guided transversus abdominis plane block for Abdominal hysterectomy as postoperative analgesia.

Group D "bupivacaine +normal saline +dexamethasone"; Group M "bupivacaine +normal saline +MgSO4"

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 35-70 years
• Female patients
• American society of anesthesiologists (ASA) physical state I-II
• Undergoing Total Abdominal Hysterectomy

You may not qualify if:

• Patient's refusal
• Cardio-respiratory conditions
• Convulsions
• Local infection at the block's site
• Bleeding diathesis
• Known allergy to any drugs used in this study

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• Balakrishna KP, Kagalkar ND, Suntan A. Efficacy of Magnesium Sulfate as an Adjuvant to Bupivacaine in Transversus Abdominis Plane Block for Abdominal Hysterectomy Surgeries. Cureus. 2023 Apr 5;15(4):e37156. doi: 10.7759/cureus.37156. eCollection 2023 Apr.

  PMID: 37159770 BACKGROUND

• Shambhavi T, Das S, Senapati LK, Padhi PP. Comparative evaluation of bupivacaine with magnesium sulphate and dexamethasone as adjuvants in ultrasound-guided transversus abdominis plane block for open unilateral inguinal hernia surgeries: A randomised controlled trial. Indian J Anaesth. 2023 Apr;67(4):370-375. doi: 10.4103/ija.ija_1091_21. Epub 2023 Apr 10.

  PMID: 37303878 BACKGROUND

MeSH Terms

Interventions

Dental Occlusion

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Zain Alabdin Zaree Hassan, Professor

  Assiut University

  STUDY CHAIR

• Ahmed Talaat Ahmed, Lecture

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Ahmed Hamdy Mohamed Saleh, Resident

CONTACT

+201010958730; abohamdy753@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident physician at the anesthesiology and intensive care unit at Assuit University Hospitals

Study Record Dates

• First Submitted: October 29, 2023
• First Posted: December 12, 2023
• Study Start: December 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2025
• Last Updated: December 12, 2023

Record last verified: 2023-12