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

TAP Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06166108
• Other study ID #: TAP block in Hysterectomy
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: December 2023
• Est. completion date: November 2025

Study information

• Verified date: December 2023
• Source: Assiut University
• Contact: Ahmed Hamdy Mohamed Saleh, Resident
• Phone: +201010958730
• Email: abohamdy753[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Total abdominal hysterectomy (TAH) is accompanied by an extensive inflammatory response resulting in postoperative discomfort and misery. Such patients require appropriate analgesic treatment to reduce morbidity and complications by blunting autonomic, somatic, and endocrine reflexes. As a result, postoperative analgesia following TAH calls for a multimodal approach.

One of the regional techniques routinely used is the transversus abdominis plane (TAP) block. Its widespread use in abdominal surgeries is due to its technical simplicity and trustworthy analgesia. This block implies administering local anesthetic between the internal oblique muscle and transversus abdominis muscle, which is marked by the lumbar Petit triangle. The primary drawback of single-shot regional blocks is their short duration of action when administered with local anesthetic alone. Several adjuvants, including opioids, alpha 2 agonists, N-methylD-aspartate (NMDA) receptor antagonists, and other drugs, have been utilized to extend the duration of blocks. Opioids are by far the most often used adjuvants, but they accompany a host of unpleasant side effects, such as respiratory depression, drowsiness, nausea, and vomiting. In some studies, using alpha 2 agonists such as Dexmedetomidine and Clonidine has been related to drowsiness and bradycardia.

MgSO4 is an N-methyl-D-aspartate (NMDA) receptor antagonist. It acts by non-competitive antagonism blocking the voltage-dependent ion channels.

Dexamethasone is a highly potent, long-acting glucocorticoid. It inhibits potassium conductance by binding to glucocorticoid receptors which decrease the activity of nociceptive C-fibres and may also prolong the analgesia duration through systemic anti'-inflammatory effects and local vasoconstrictive action.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: November 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age 35-70 years

• Female patients

• American society of anesthesiologists (ASA) physical state I-II

• Undergoing Total Abdominal Hysterectomy

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• TAP Block

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Postoperative hemodynamic parameters	Hemodynamic parameters including HR(beat/min), MAP(mmHg), and SpO2(%)	24 hours postoperative
Secondary	Time required for the first rescue analgesia	the time at which the patient demand analgesia will be recorded for each patient	24 hours postoperative
Secondary	Total amount of rescue analgesic consumption during the first 24 hours postoperatively		24 hours postoperative
Secondary	Patient satisfaction score	Five-points Likert scale: to evaluate the patients' satisfaction regarding the whole procedure at the end of the postoperative 24 hours. It ranged from (1=very satisfied, 2=satisfied, 3=neither satisfied nor dissatisfied, 4=dissatisfied, 5=very dissatisfied)	24 hours postoperative
Secondary	PONV intensity by postoperatively	The number of attacks of nausea for 24 h will be assessed at 0.5, 1, 2, 4, 6, 12 and 24 h and will be recorded as yes/no. •The number of attacks of vomiting for 24 h will be assessed at 0.5, 1, 2, 4, 6, 12 and 24 h postoperatively and will be recorded as yes/no.	24 hours postoperative