Bilateral Transversus Abdominis Plane Block With or Without Magnesium

NCT02680626 | Terminated Phase 4

• 1 other identifier: ANAE-275-15
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Pain score

  2, 4, 6, 8, and 24 hours after receiving TAP block

• Time to post-anesthetic care unit discharge

  First occurrence during the initial 24 hours after surgery

• Nausea score

  2, 4, 6, 8, and 24 hours after receiving TAP block

• Pruritis score

  2, 4, 6, 8, and 24 hours after receiving TAP block

• Sensory block

  30 minutes after arrival into the post-anesthetic care unit, and at 2, 4, 6, and 8 hours after receiving TAP blocks

Study Arms (2)

Magnesium

EXPERIMENTAL

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

Drug: Magnesium Sulfate; Drug: Ropivacaine

Non-magnesium

ACTIVE COMPARATOR

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

Drug: Ropivacaine

Interventions

Magnesium Sulfate DRUG

Given via transversus abdominis plane block

Also known as: Sulfamag, Epsom salt, Health Canada DIN: 02139499

Magnesium

Ropivacaine DRUG

Given via transversus abdominis plane block

Also known as: Naropin

Magnesium; Non-magnesium

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Anthony Ho: lead

Study Sites (1)

Kingston General Hospital

Kingston, Ontario, K7L2V7, Canada

Location

Related Publications (19)

• 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.

  PMID: 23291970 BACKGROUND

• 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.

  PMID: 21296242 BACKGROUND

• 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.

  PMID: 23454825 BACKGROUND

• 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.

  PMID: 17179269 BACKGROUND

• 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.

  PMID: 19020158 BACKGROUND

• 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.

  PMID: 16418039 BACKGROUND

• 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.

  PMID: 18165577 BACKGROUND

• 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.

  PMID: 19376789 BACKGROUND

• 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.

  PMID: 19561014 BACKGROUND

• 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.

  PMID: 19749115 BACKGROUND

• 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.

  PMID: 14634861 BACKGROUND

• 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.

  PMID: 10618948 BACKGROUND

• 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.

  PMID: 1734773 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 22012543 BACKGROUND

• 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.

  PMID: 16701189 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 25886097 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Magnesium Sulfate; Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Anthony Ho, MD

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, GFT

Study Record Dates

• First Submitted: February 9, 2016
• First Posted: February 11, 2016
• Study Start: January 1, 2016
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: April 13, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)