Adding Magnesium Sulfate to Bupivacaine in Ultrasound Guided Paravertebral Block for Laparoscopic Cholecystectomy

NCT05099250 | Completed DMC

• 1 other identifier: MS/18.01.12
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Laparoscopic cholecystectomy is one of the most commonly performed minimally invasive surgical procedures for the treatment of symptomatic cholelithiasis Laparoscopic cholecystectomy has clear benefits when compared with open surgery, but post-operative pain is still a common complaint after it The patient undergoing laparoscopic cholecystectomy suffers from severe post-operative pain, it can prolong hospital stay and lead to increased morbidity Post-operative laparoscopic cholecystectomy pain can be relieved by some methods pre-emptive analgesic regimens containing ketamine, regional anesthesia techniques including paravertebral block Paravertebral Block is a regional anesthetic and analgesic technique which may offer comparable analgesic effectiveness with minimal side effects Paravertebral Block has been used a lot in the last two decades, several studies show its efficacy in, thoracoscopic surgery and laparoscopic cholecystectomy .Paravertebral block is the technique of injecting local anesthetic adjacent to the thoracic vertebra close to where the spinal nerves emerge from the intervertebral foramina, resulting in ipsilateral somatic and sympathetic nerve blockade in multiple dermatomes above and below the site of injection . Bupivacaine is a local anesthetic that is capable of producing prolonged high quality analgesia in the postoperative period It is shown that paravertebral block using bupivacaine significantly reduces pain score Many drugs have been used as adjuvants to local anesthetic in peripheral nerve block in order to augment its analgesic effect and prolong the duration of the block such as opioids and magnesium sulfate Many studies have reported safety and efficacy of adding magnesium to local anesthetics in various regional anesthetic procedures, such as intrathecal, epidural, caudal, brachial plexus blocks and intravenous regional anesthesia. Magnesium play a major role in central nociceptive transmission, modulation and sensitization of acute and chronic pain states due to its antagonistic effect on N-methyl D-aspartate (NMDA) receptors .

Conditions

Laparoscopic Cholecystectomy

Keywords

paravertebral block laparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (1)

• change of postoperative pain intensity

  measured by visual analogue scale . All patients were familiar with the use of 0 -10 visual analogue scale identifying 0 as no pain and 10 as worst imaginable pain. Pain intensity was assessed at rest and during cough with VAS score at 1, 2, 6, 12 and 24 hours postoperatively. When the patients experienced pain (VAS score \> 3), A bolus dose of IV morphine 0.02 mg/kg was administered till visual analogue scale score ≤ 4 was attained.

  first 24 hours postoperatively

Secondary Outcomes (2)

• change opioid consumption in first 24 hours

  first 24 hours postoperatively

• change of analgesia duration

  first 24 hours postoperatively

Study Arms (2)

Control group: Bupivacaine Group (B group)

PLACEBO COMPARATOR

Included patients who received 17 mL of 0.25% bupivacaine + 3 mL saline 0.9% in a total volume of 20 ml on each side

Drug: Bupivacain; Other: saline

Magnesium Group (M group)

ACTIVE COMPARATOR

Included patients who received 17 mL of 0.25% bupivacaine + 3 mL of 75 mg magnesium sulfate diluted in 0.9% saline in a total volume of 20 ml on each side.

Drug: Bupivacain; Drug: magnesium sulfate; Other: saline

Interventions

Bupivacain DRUG

local anesthetic agent

Also known as: Control group: Bupivacaine Group (B group, Saline

Control group: Bupivacaine Group (B group); Magnesium Group (M group)

magnesium sulfate DRUG

In the central nervous system , it has depressant effects, by antagonism at NMDA receptors and through inhibition of release of catecholamines

Also known as: Magnesium Group (M group), saline

Magnesium Group (M group)

saline OTHER

medical solution

Control group: Bupivacaine Group (B group); Magnesium Group (M group)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients scheduled for elective laparoscopic cholecystectomy were enrolled in this study

You may not qualify if:

• patient refusal to participate,
• Sever renal or cardiac illness,
• Pulmonary diseases as emphysema or chronic obstructive pulmonary disease
• Neuromuscular diseases (as myopathies and myasthenia gravies), -Hematological diseases, bleeding or coagulation abnormality,
• Psychiatric diseases,
• Local skin infection and sepsis at site of the block,
• Known hypersensitivity to the study drugs, and Severe chest wall deformity, e.g. scoliosis.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Marwa Ibrahim Mohamed Abdo

Al Mansurah, Egypt

Location

Related Publications (14)

• Agarwal A, Batra RK, Chhabra A, Subramaniam R, Misra MC. The evaluation of efficacy and safety of paravertebral block for perioperative analgesia in patients undergoing laparoscopic cholecystectomy. Saudi J Anaesth. 2012 Oct-Dec;6(4):344-9. doi: 10.4103/1658-354X.105860.

  PMID: 23493523 BACKGROUND

• Bisgaard T, Klarskov B, Rosenberg J, Kehlet H. Characteristics and prediction of early pain after laparoscopic cholecystectomy. Pain. 2001 Feb 15;90(3):261-269. doi: 10.1016/S0304-3959(00)00406-1.

  PMID: 11207398 BACKGROUND

• Lau H, Brooks DC. Predictive factors for unanticipated admissions after ambulatory laparoscopic cholecystectomy. Arch Surg. 2001 Oct;136(10):1150-3. doi: 10.1001/archsurg.136.10.1150.

  PMID: 11585507 BACKGROUND

• Salihoglu Z, Yildirim M, Demiroluk S, Kaya G, Karatas A, Ertem M, Aytac E. Evaluation of intravenous paracetamol administration on postoperative pain and recovery characteristics in patients undergoing laparoscopic cholecystectomy. Surg Laparosc Endosc Percutan Tech. 2009 Aug;19(4):321-3. doi: 10.1097/SLE.0b013e3181b13933.

  PMID: 19692881 BACKGROUND

• Davies RG, Myles PS, Graham JM. A comparison of the analgesic efficacy and side-effects of paravertebral vs epidural blockade for thoracotomy--a systematic review and meta-analysis of randomized trials. Br J Anaesth. 2006 Apr;96(4):418-26. doi: 10.1093/bja/ael020. Epub 2006 Feb 13.

  PMID: 16476698 BACKGROUND

• Klein SM, Bergh A, Steele SM, Georgiade GS, Greengrass RA. Thoracic paravertebral block for breast surgery. Anesth Analg. 2000 Jun;90(6):1402-5. doi: 10.1097/00000539-200006000-00026.

  PMID: 10825328 BACKGROUND

• Soni AK, Conacher ID, Waller DA, Hilton CJ. Video-assisted thoracoscopic placement of paravertebral catheters: a technique for postoperative analgesia for bilateral thoracoscopic surgery. Br J Anaesth. 1994 Apr;72(4):462-4. doi: 10.1093/bja/72.4.462.

  PMID: 8155453 BACKGROUND

• Cheema SP, Ilsley D, Richardson J, Sabanathan S. A thermographic study of paravertebral analgesia. Anaesthesia. 1995 Feb;50(2):118-21. doi: 10.1111/j.1365-2044.1995.tb15092.x.

  PMID: 7710020 BACKGROUND

• Kopacz DJ, Allen HW, Thompson GE. A comparison of epidural levobupivacaine 0.75% with racemic bupivacaine for lower abdominal surgery. Anesth Analg. 2000 Mar;90(3):642-8. doi: 10.1097/00000539-200003000-00026.

  PMID: 10702451 BACKGROUND

• Bilgin M, Akcali Y, Oguzkaya F. Extrapleural regional versus systemic analgesia for relieving postthoracotomy pain: a clinical study of bupivacaine compared with metamizol. J Thorac Cardiovasc Surg. 2003 Nov;126(5):1580-3. doi: 10.1016/s0022-5223(03)00701-3.

  PMID: 14666036 BACKGROUND

• Akhondzade R, Nesioonpour S, Gousheh M, Soltani F, Davarimoghadam M. The Effect of Magnesium Sulfate on Postoperative Pain in Upper Limb Surgeries by Supraclavicular Block Under Ultrasound Guidance. Anesth Pain Med. 2017 Jun 10;7(3):e14232. doi: 10.5812/aapm.14232. eCollection 2017 Jun.

  PMID: 28924560 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

• Choyce A, Peng P. A systematic review of adjuncts for intravenous regional anesthesia for surgical procedures. Can J Anaesth. 2002 Jan;49(1):32-45. doi: 10.1007/BF03020416.

  PMID: 11782326 BACKGROUND

• Haefeli M, Elfering A. Pain assessment. Eur Spine J. 2006 Jan;15 Suppl 1(Suppl 1):S17-24. doi: 10.1007/s00586-005-1044-x. Epub 2005 Dec 1.

  PMID: 16320034 BACKGROUND

MeSH Terms

Interventions

Bupivacaine; Sodium Chloride; Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Magnesium Compounds; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Ghada Fa Al-Rahamawy, MD

  Professor of Anesthesia - Intensive Care Faculty of Medicine - Mansoura University

  STUDY CHAIR

• Hesham Ah Abdel Mohaiemn, MD

  Assistant Professor of Anesthesia - Intensive Care Faculty of Medicine - Mansoura University

  STUDY DIRECTOR

• Marwa Ib Abdo, MD

  Lecturer of Anesthesia Intensive Care Faculty of Medicine - Mansoura University

  PRINCIPAL INVESTIGATOR

• Asmaa Ah Hossain, Ph.D

  Residant in Anesthesia - Intensive Care Faculty of Medicine - Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The groups allocated are concealed in sealed opaque envelopes which were not opened until patient consent was obtained. The two groups were: 1. Control group: Bupivacaine Group (B group) N=25 : Included patients who received 17 mL of 0.25% bupivacaine + 3 mL saline 0.9% in a total volume of 20 ml on each side. 2. Magnesium Group (M group) N=25 : Included patients who received 17 mL of 0.25% bupivacaine + 3 mL of 75 mg magnesium sulfate diluted in 0.9% saline in a total volume of 20 ml on each side. All patients were performed by the same anesthetic team with standard procedure.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia and Surgical Intensive Care-Faculty of Medicine - Mansoura University

Model Details: The groups allocated are concealed in sealed opaque envelopes which were not opened until patient consent was obtained. The two groups were: 1. Control group: Bupivacaine Group (B group) N=25 : Included patients who received 17 mL of 0.25% bupivacaine + 3 mL saline 0.9% in a total volume of 20 ml on each side. 2. Magnesium Group (M group) N=25 : Included patients who received 17 mL of 0.25% bupivacaine + 3 mL of 75 mg magnesium sulfate diluted in 0.9% saline in a total volume of 20 ml on each side. All patients were performed by the same anesthetic team with standard procedure.

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: October 29, 2021
• Study Start: July 15, 2019
• Primary Completion: September 10, 2020
• Study Completion: February 15, 2021
• Last Updated: November 8, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)