Bilateral Transversus Abdominis Plane Block With or Without Magnesium

April 11, 2023 updated by: Dr. Anthony Ho

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L2V7
        • Kingston General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first dose of post-operative opioid
Time Frame: First occurrence during hospitalization (up to 24 hours postoperatively)
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
Time Frame: Cumulative dose consumed at 2, 4, 6, 8, and 25 hours after receiving TAP blocks
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
Time Frame: 2, 4, 6, 8, and 24 hours after receiving TAP block
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
Time Frame: First occurrence during the initial 24 hours after surgery
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
Time Frame: 2, 4, 6, 8, and 24 hours after receiving TAP block
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
Time Frame: 2, 4, 6, 8, and 24 hours after receiving TAP block
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
Time Frame: 30 minutes after arrival into the post-anesthetic care unit, and at 2, 4, 6, and 8 hours after receiving TAP blocks
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
Time Frame: At 24 hours after receiving TAP blocks
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
Time Frame: At 24 hours after receiving TAP blocks
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
Time Frame: At 24 hours after receiving TAP blocks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Anthony Ho

Investigators

  • Principal Investigator: Anthony Ho, MD, Queen's University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

February 1, 2020

Study Completion (Actual)

February 1, 2020

Study Registration Dates

First Submitted

February 9, 2016

First Submitted That Met QC Criteria

February 9, 2016

First Posted (Estimate)

February 11, 2016

Study Record Updates

Last Update Posted (Estimate)

April 13, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANAE-275-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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