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Bilateral Transversus Abdominis Plane Block With or Without Magnesium

Primary Purpose

Pain, Postoperative

Status
Terminated
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Magnesium Sulfate
Ropivacaine
Sponsored by
Dr. Anthony Ho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Kingston General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Magnesium

Non-magnesium

Arm Description

Participants in this arm will receive magnesium sulfate + ropivacaine in their bilateral transversus abdominis plane blocks

Participants in this arm will receive saline + ropivacaine in their bilateral transversus abdominis plane blocks

Outcomes

Primary Outcome Measures

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).
Cumulative opioid consumption
Investigators will record the total amount of opioid consumed between receiving the TAP block and 24 hours later.

Secondary Outcome Measures

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.
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.
Nausea score
Nausea will be rated from 0 (none) to 3 (vomiting) at various time points after receiving TAP block
Pruritis score
Pruritis will be rated from 0 (none) to 3 (severe) at various time points after receiving TAP blocks.
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.
Patient satisfaction
Participants will be asked to rate their satisfaction from 1 (poor) to 4 (excellent)
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)
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.

Full Information

First Posted
February 9, 2016
Last Updated
April 11, 2023
Sponsor
Dr. Anthony Ho
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1. Study Identification

Unique Protocol Identification Number
NCT02680626
Brief Title
Bilateral Transversus Abdominis Plane Block With or Without Magnesium
Official Title
Bilateral Transversus Abdominis Plane Block With or Without Magnesium for Total Abdominal Hysterectomy With or Without Salpingo-oophorectomy: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
Pfannenstiel hysterectomies are now rarely performed so cannot recruit eligible patients
Study Start Date
January 2016 (undefined)
Primary Completion Date
February 2020 (Actual)
Study Completion Date
February 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Anthony Ho

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Magnesium
Arm Type
Experimental
Arm Description
Participants in this arm will receive magnesium sulfate + ropivacaine in their bilateral transversus abdominis plane blocks
Arm Title
Non-magnesium
Arm Type
Active Comparator
Arm Description
Participants in this arm will receive saline + ropivacaine in their bilateral transversus abdominis plane blocks
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Other Intervention Name(s)
Sulfamag, Epsom salt, Health Canada DIN: 02139499
Intervention Description
Given via transversus abdominis plane block
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Naropin
Intervention Description
Given via transversus abdominis plane block
Primary Outcome Measure Information:
Title
Time to first dose of post-operative opioid
Description
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).
Time Frame
First occurrence during hospitalization (up to 24 hours postoperatively)
Title
Cumulative opioid consumption
Description
Investigators will record the total amount of opioid consumed between receiving the TAP block and 24 hours later.
Time Frame
Cumulative dose consumed at 2, 4, 6, 8, and 25 hours after receiving TAP blocks
Secondary Outcome Measure Information:
Title
Pain score
Description
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.
Time Frame
2, 4, 6, 8, and 24 hours after receiving TAP block
Title
Time to post-anesthetic care unit discharge
Description
Investigators will note the time lapsed between a patient receiving their TAP block and when she is discharged from the PACU.
Time Frame
First occurrence during the initial 24 hours after surgery
Title
Nausea score
Description
Nausea will be rated from 0 (none) to 3 (vomiting) at various time points after receiving TAP block
Time Frame
2, 4, 6, 8, and 24 hours after receiving TAP block
Title
Pruritis score
Description
Pruritis will be rated from 0 (none) to 3 (severe) at various time points after receiving TAP blocks.
Time Frame
2, 4, 6, 8, and 24 hours after receiving TAP block
Title
Sensory block
Description
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.
Time Frame
30 minutes after arrival into the post-anesthetic care unit, and at 2, 4, 6, and 8 hours after receiving TAP blocks
Title
Patient satisfaction
Description
Participants will be asked to rate their satisfaction from 1 (poor) to 4 (excellent)
Time Frame
At 24 hours after receiving TAP blocks
Title
Quality of Recovery score
Description
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)
Time Frame
At 24 hours after receiving TAP blocks
Title
Side effects
Description
Participants will be asked whether they experienced any side effects during the 24 hours between receiving TAP block and end of the study.
Time Frame
At 24 hours after receiving TAP blocks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Ho, MD
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L2V7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23291970
Citation
Gasanova I, Grant E, Way M, Rosero EB, Joshi GP. Ultrasound-guided transversus abdominal plane block with multimodal analgesia for pain management after total abdominal hysterectomy. Arch Gynecol Obstet. 2013 Jul;288(1):105-11. doi: 10.1007/s00404-012-2698-3. Epub 2013 Jan 6.
Results Reference
background
PubMed Identifier
21296242
Citation
Siddiqui MR, Sajid MS, Uncles DR, Cheek L, Baig MK. A meta-analysis on the clinical effectiveness of transversus abdominis plane block. J Clin Anesth. 2011 Feb;23(1):7-14. doi: 10.1016/j.jclinane.2010.05.008.
Results Reference
background
PubMed Identifier
23454825
Citation
Griffiths JD, Le NV, Grant S, Bjorksten A, Hebbard P, Royse C. Symptomatic local anaesthetic toxicity and plasma ropivacaine concentrations after transversus abdominis plane block for Caesarean section. Br J Anaesth. 2013 Jun;110(6):996-1000. doi: 10.1093/bja/aet015. Epub 2013 Mar 1.
Results Reference
background
PubMed Identifier
17179269
Citation
McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f. Erratum In: Anesth Analg. 2007 May;104(5):1108.
Results Reference
background
PubMed Identifier
19020158
Citation
Carney J, McDonnell JG, Ochana A, Bhinder R, Laffey JG. The transversus abdominis plane block provides effective postoperative analgesia in patients undergoing total abdominal hysterectomy. Anesth Analg. 2008 Dec;107(6):2056-60. doi: 10.1213/ane.0b013e3181871313.
Results Reference
background
PubMed Identifier
16418039
Citation
O'Donnell BD, McDonnell JG, McShane AJ. The transversus abdominis plane (TAP) block in open retropubic prostatectomy. Reg Anesth Pain Med. 2006 Jan-Feb;31(1):91. doi: 10.1016/j.rapm.2005.10.006. No abstract available. Erratum In: Reg Anesth Pain Med. 2006 May-Jun;31(3):286. McDonnell, John G [added]; McShane, Alan J [added].
Results Reference
background
PubMed Identifier
18165577
Citation
McDonnell JG, Curley G, Carney J, Benton A, Costello J, Maharaj CH, Laffey JG. The analgesic efficacy of transversus abdominis plane block after cesarean delivery: a randomized controlled trial. Anesth Analg. 2008 Jan;106(1):186-91, table of contents. doi: 10.1213/01.ane.0000290294.64090.f3.
Results Reference
background
PubMed Identifier
19376789
Citation
El-Dawlatly AA, Turkistani A, Kettner SC, Machata AM, Delvi MB, Thallaj A, Kapral S, Marhofer P. Ultrasound-guided transversus abdominis plane block: description of a new technique and comparison with conventional systemic analgesia during laparoscopic cholecystectomy. Br J Anaesth. 2009 Jun;102(6):763-7. doi: 10.1093/bja/aep067. Epub 2009 Apr 17. Erratum In: Br J Anaesth. 2009 Oct;103(4):622.
Results Reference
background
PubMed Identifier
19561014
Citation
Niraj G, Searle A, Mathews M, Misra V, Baban M, Kiani S, Wong M. Analgesic efficacy of ultrasound-guided transversus abdominis plane block in patients undergoing open appendicectomy. Br J Anaesth. 2009 Oct;103(4):601-5. doi: 10.1093/bja/aep175. Epub 2009 Jun 26.
Results Reference
background
PubMed Identifier
19749115
Citation
Bonnet F, Berger J, Aveline C. Transversus abdominis plane block: what is its role in postoperative analgesia? Br J Anaesth. 2009 Oct;103(4):468-70. doi: 10.1093/bja/aep243. No abstract available.
Results Reference
background
PubMed Identifier
14634861
Citation
Schlingmann KP, Konrad M, Seyberth HW. Genetics of hereditary disorders of magnesium homeostasis. Pediatr Nephrol. 2004 Jan;19(1):13-25. doi: 10.1007/s00467-003-1293-z. Epub 2003 Nov 22.
Results Reference
background
PubMed Identifier
10618948
Citation
Fawcett WJ, Haxby EJ, Male DA. Magnesium: physiology and pharmacology. Br J Anaesth. 1999 Aug;83(2):302-20. doi: 10.1093/bja/83.2.302.
Results Reference
background
PubMed Identifier
1734773
Citation
James MF. Clinical use of magnesium infusions in anesthesia. Anesth Analg. 1992 Jan;74(1):129-36. doi: 10.1213/00000539-199201000-00021. No abstract available.
Results Reference
background
Citation
El-Shamaa HA, Ibrahim M, Eldesuky HI. Magnesium sulfate in femoral nerve block, does postoperative analgesia differ? A comparative study. Egypt Journal of Anaesthesia 30(2): 169-73, 2013
Results Reference
background
PubMed Identifier
22012543
Citation
Lee AR, Yi HW, Chung IS, Ko JS, Ahn HJ, Gwak MS, Choi DH, Choi SJ. Magnesium added to bupivacaine prolongs the duration of analgesia after interscalene nerve block. Can J Anaesth. 2012 Jan;59(1):21-7. doi: 10.1007/s12630-011-9604-5. Epub 2011 Oct 20.
Results Reference
background
PubMed Identifier
16701189
Citation
Gunduz A, Bilir A, Gulec S. Magnesium added to prilocaine prolongs the duration of axillary plexus block. Reg Anesth Pain Med. 2006 May-Jun;31(3):233-6. doi: 10.1016/j.rapm.2006.03.001.
Results Reference
background
Citation
Abdelfatah AM, Elshaer AN. The effect of adding magnesium sulfate to lidocaine in an interscalene plexus block for shoulder arthroscopic acromioplasty. Ain-Shams Journal of Anesthesiology 7(1): 59-64, 2014.
Results Reference
background
PubMed Identifier
25886097
Citation
Yousef GT, Ibrahim TH, Khder A, Ibrahim M. Enhancement of ropivacaine caudal analgesia using dexamethasone or magnesium in children undergoing inguinal hernia repair. Anesth Essays Res. 2014 Jan-Apr;8(1):13-9. doi: 10.4103/0259-1162.128895.
Results Reference
background
Citation
Goyal P, Jaiswal R, Hooda S, Hoyal R, Lal J. Role of magnesium sulphate for brachial plexus analgesia. Internet Journal of Anesthesiology. 21(1): 1-6, 2008.
Results Reference
background

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Bilateral Transversus Abdominis Plane Block With or Without Magnesium

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