Clinical trial NCT06166108: Magnesium Sulphate Versus Dexamethasone as an Adjuvant to Bupivacaine in TAP Block for Abdominal Hysterectomy
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: TAP Block
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 56
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparasion of postoperative NRS score for 24 hours between the two groups
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: Postoperative hemodynamic parameters
timeFrame: 24 hours postoperative
measure: Time required for the first rescue analgesia
timeFrame: 24 hours postoperative
measure: Total amount of rescue analgesic consumption during the first 24 hours postoperatively
timeFrame: 24 hours postoperative
measure: Patient satisfaction score
timeFrame: 24 hours postoperative
measure: PONV intensity by postoperatively
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Zain Alabdin Zaree Hassan, Professor
role: STUDY_CHAIR
affiliation: Assiut University
name: Ahmed Talaat Ahmed, Lecture
role: STUDY_DIRECTOR
References:
citation: 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.
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.