Bilateral Transversus Abdominis Plane Block With or Without Magnesium

Study Overview
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Brief Summary
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Pain control after surgery is important for patient well-being and recovery. We are interested in determining whether we can improve the duration of action of a local anesthetic procedure (transversus abdominis plane block, or TAP block) by adding magnesium sulfate to local anesthetics given to patients after total abdominal hysterectomy with or without salpingo-oophorectomy.

Detailed Description
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Total abdominal hysterectomy (TAH) with or without salpingo-oophorectomy is a commonly performed major surgical procedure that results in significant postoperative pain. Traditionally, this pain has been treated with a multimodal approach which includes opioids, often administered via a patient-controlled analgesia (PCA) pump. Common side effects of opioids include sedation, nausea, vomiting, constipation, and pruritus. Thus, to overcome such undesirable side effects, other approaches to pain management have been explored, including post-operative transversus abdominis plane (TAP) blocks. TAP blocks are a popular analgesia technique for abdominal surgery with an incision between the sixth thoracic (T10) vertebrae and the first lumbar (L1) vertebrae. The block involves infiltration of local anesthetic (LA) by an anesthesiologist under direct ultrasound guidance. The anesthetic is deposited into a plane between the internal oblique and transversus abdominis muscles, which contain thoracolumbar nerves that originate from the T6 to L1 spinal roots. These nerves supply sensation to the anterolateral abdominal wall, the area responsible for incision-related pain following TAH ± unilateral/bilateral salpingo-oophorectomy. TAP blocks are a low risk procedure with very rare side-effects including bowel or peritoneum perforation, and local anesthetic toxicity. Almost all anesthesiologists are familiar with performing such a block, which is routinely done under ultrasound guidance to minimize the risk of perforation. Previous studies demonstrate TAP block efficacy in various abdominal surgery including hysterectomy, colon resection, Caesarean section, retropubic prostatectomy, laparoscopic cholecystectomy, and open appendectomy. While TAP blocks have been shown to provide patients with a statistically significant increase in the time to first analgesic request, this mean delay is typically less than 3 hours. To overcome the limited duration of action, we are proposing the addition of magnesium as an adjunct to the LA solution infiltrated in the block. Other regional anesthesia techniques have trialed various adjuncts including epinephrine, dexamethasone, clonidine, and recently magnesium. The goal of using such adjuncts is to prolong and enhance analgesia, and potentially even decrease total LA required. Our study will investigate the use of magnesium as an adjunct to LA in bilateral TAP blocks to increase the duration of analgesia. Magnesium is the fourth most abundant cation in the body and the second most abundant intracellular cation after potassium. The minimum recommended daily intake of magnesium for adults is 0.25 mmol (6 mg)/kg body weight. Magnesium is a natural analgesic through antagonism of N-methyl-D-aspartate receptors. When added to LA, magnesium has been shown to improve the quality and duration of analgesia of neuraxial, femoral, and brachial plexus blocks. In fact, brachial plexus analgesia has been produced with magnesium sulfate (MgSO4) alone. Magnesium as an adjunct to TAP blocks has never been previously investigated in any setting, thus we propose a study to specifically investigate its potential effects in prolonging analgesia in patients undergoing elective TAH ± unilateral or bilateral salpingo-oophorectomy. We hypothesize that the quality and duration of analgesia can be improved by adding a moderate amount of MgSO4 to the local anesthetic used in the TAP blocks.

Official Title
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Bilateral Transversus Abdominis Plane Block With or Without Magnesium for Total Abdominal Hysterectomy With or Without Salpingo-oophorectomy: a Randomized Controlled Trial

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Magnesium Sulfate
* Drug: Ropivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists (ASA) rating I-III Age 18-75 years old Female Undergoing elective total abdominal hysterectomy (TAH) with or without uni/bilateral salpingo-oophorectomy (BSO) under general anesthesia with a Pfannenstiel incision Admitted to hospital postoperatively (inpatients) Competent to provide informed consent Exclusion Criteria: Emergency TAH ± BSO ASA IV-V Allergy or sensitivity to study-related medications Taking any medications that are contraindicated for the use of any of our study drugs Midline incision Other regional anesthesia technique (e.g. epidural) Morbidly Obese (BMI > 40) Incompetent to provide informed consent eGFR < 50 Impaired liver function (INR > 1.5) Pre-existing chronic pain condition requiring chronic opioid use Significant co-existing cardiovascular disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magnesium<br>Participants in this arm will receive magnesium sulfate + ropivacaine in their bilateral transversus abdominis plane blocks | Drug: Magnesium Sulfate<br>* Given via transversus abdominis plane block<br>* Other names: Sulfamag, Epsom salt, Health Canada DIN: 02139499;Drug: Ropivacaine<br>* Given via transversus abdominis plane block<br>* Other names: Naropin;|
| Active Comparator: Non-magnesium<br>Participants in this arm will receive saline + ropivacaine in their bilateral transversus abdominis plane blocks | Drug: Ropivacaine<br>* Given via transversus abdominis plane block<br>* Other names: Naropin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first dose of post-operative opioid | Investigators will note the time lapsed between end of surgery (when TAP block administered) and the first request for additional analgesia (given using patient controlled analgesia pumps, as is standard of care at our institution). | First occurrence during hospitalization (up to 24 hours postoperatively) | 
| Cumulative opioid consumption | Investigators will record the total amount of opioid consumed between receiving the TAP block and 24 hours later. | Cumulative dose consumed at 2, 4, 6, 8, and 25 hours after receiving TAP blocks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | Visual analog scales will be used to assess pain at rest and upon coughing in patients at various time points after receiving the TAP block after surgery. | 2, 4, 6, 8, and 24 hours after receiving TAP block | 
| Time to post-anesthetic care unit discharge | Investigators will note the time lapsed between a patient receiving their TAP block and when she is discharged from the PACU. | First occurrence during the initial 24 hours after surgery | 
| Nausea score | Nausea will be rated from 0 (none) to 3 (vomiting) at various time points after receiving TAP block | 2, 4, 6, 8, and 24 hours after receiving TAP block | 
| Pruritis score | Pruritis will be rated from 0 (none) to 3 (severe) at various time points after receiving TAP blocks. | 2, 4, 6, 8, and 24 hours after receiving TAP block | 
| Sensory block | Ice will be placed on each side of the abdomen and on the upper arm. The participant will be asked if she can feel the ice on her abdomen, and if it feels similar to that on her upper arm. | 30 minutes after arrival into the post-anesthetic care unit, and at 2, 4, 6, and 8 hours after receiving TAP blocks | 
| Patient satisfaction | Participants will be asked to rate their satisfaction from 1 (poor) to 4 (excellent) | At 24 hours after receiving TAP blocks | 
| Quality of Recovery score | Participants will be asked to fill out this 9-part survey, which consists of rating 9 statements related to recovery from anesthetic and surgery on a scale from 0 (not at all) to 2 (most of the time) | At 24 hours after receiving TAP blocks | 
| Side effects | Participants will be asked whether they experienced any side effects during the 24 hours between receiving TAP block and end of the study. | At 24 hours after receiving TAP blocks |