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

Assiut University

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: TAP Block

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06166108

TAP block in Hysterectomy

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 estimated patients

Sex: Female

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Group M "bupivacaine +normal saline +MgSO4"

Active Comparator group

Description:

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)

Treatment:

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

Group D "bupivacaine +normal saline +dexamethasone"

Active Comparator group

Description:

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

Treatment:

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