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

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ClinicalTrials.gov Identifier: NCT05099250
Recruitment Status : Completed
First Posted : October 29, 2021
Last Update Posted : November 8, 2021
Sponsor:
Information provided by (Responsible Party):
Marwa Ibrahim Mohamed Abdo,MD, Mansoura University

Tracking Information
First Submitted Date  ICMJE August 19, 2021
First Posted Date  ICMJE October 29, 2021
Last Update Posted Date November 8, 2021
Actual Study Start Date  ICMJE July 15, 2019
Actual Primary Completion Date September 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2021)
change of postoperative pain intensity [ Time Frame: first 24 hours postoperatively ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 18, 2021)
improvement of postoperative pain [ Time Frame: first 24 hours postoperatively ]
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. Duration of analgesia was defined as the time from applying the block till the first intravenous morphine administration 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2021)
  • change opioid consumption in first 24 hours [ Time Frame: first 24 hours postoperatively ]
    measured by recording the time of first post-operative administration of morphine. Also, the total dose of post-operative morphine (mg) consumed in the first postoperative 24 hours was calculated in both groups.
  • change of analgesia duration [ Time Frame: first 24 hours postoperatively ]
    duration of analgesia was defined as the time from applying the block till the first intravenous morphine administration
Original Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2021)
change opioid consumption in first 24 hours [ Time Frame: first 24 hours postoperatively ]
measured by the time of first post-operative administration of morphine was recorded. Also, the total dose of post-operative morphine (mg) consumed in the first postoperative 24 hours was calculated in both groups.Also measured by the duration of analgesia was defined as the time from applying the block till the first intravenous morphine administration
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adding Magnesium Sulfate to Bupivacaine in Ultrasound Guided Paravertebral Block for Laparoscopic Cholecystectomy
Official Title  ICMJE Evaluation of the Efficacy of Adding Magnesium Sulfate as an Adjuvant to Bupivacaine in Bilateral Ultrasound Guided Paravertebral Block for Laparoscopic Cholecystectomy
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 .

Detailed Description

Patients and Methods

Patients:

This is a blind prospective randomized controlled study that will be conducted for one year in Mansoura university hospitals after approval from the Institutional Research Board (IRB), Faculty of Medicine, Mansoura University, patients will be interviewed and written informed consents will be obtained. This study will include 26 patients of American Society of Anesthesiologists physical status grade I and grade II, of both sexes, aged between 20-60 years who will be scheduled for laparoscopic cholecystectomy.

Sample size calculation A Priori G-power analysis was done to estimate study sample size. A power of 90% was estimated with type I error of 0.05 to get an analgesic duration difference between groups of approximately 30% to yield of total sample size of 50 cases (25cases per group).

Randomization:

Fifty patients (number = 50) had laparoscopic cholecystectomy and bilateral paravertebral block during the study period. These patients were randomly allocated to undergo bilateral ultrasound guided paravertebral block. 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) Number=25 :

    Included patients who received 17 mL of 0.25% bupivacaine + 3 mL mili 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 milgram 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.

Methodology:

Anesthetic Management:

Preoperative Management:

All patients will be visited a day prior to surgery and will be assessed preoperatively by History, physical examination and laboratory evaluation (complete blood picture, coagulation profile, liver function and renal function tests). The study protocol and paravertebral block procedure will be explained to all patients. All patients will be familiar with the use of 0-10 visual analogue scale score identifying 0 as no pain and 10 as worst imaginable pain. Patient fast 6-8 hour before the time of surgery.

On arrival of the patient to the operating room routine monitoring will be applied, peripheral intravenous cannula 20 gauge will be inserted and 0.9% saline will be started to be infused. All patients will be premedicated using midazolam 0.03 mg/kg kilo intravenous.

Paravertebral block will be performed before induction of general anesthesia.

Technique of ultrasound guided paravertebral nerve block:

  • Standard precautions for the performance of ultrasound-guided nerve blocks will be followed which include continuous routine monitoring, the skin overlying the injection site should be free of signs of infection and prepped with an antiseptic solution.
  • Patient will lay in the lateral position, paravertebral block will be done using a 38 mm mile meter broadband linear array ultrasound probe.The probe surface in contact with the skin should be covered with a sterile adhesive dressing.
  • A sagittal paramedian view of the paravertebral space will be obtained by applying the probe at a point 2.5 cm centimeter lateral to the tip of the spinous process in a vertical orientation, The fifth thoracic vertebral level will be identified by palpating and counting down from the seventh cervical body.
  • The midpoint of the transducer will be aligned midway between the transverse processes of thoracic vertebra T5 and T6, 4 ml of 1 % lidocaine was injected subcutaneously at the puncture site,and 22 gauge spinal needle will be inserted in an in plane approach in a cephalad orientation and will be advanced perpendicularly to all skin planes under direct vision to puncture the superior costotransverse ligament where a click may be appreciated.
  • Following negative aspiration, 1-2 ml of study solution will be injected to verify correct position of the needle tip and the rest of study solution will be injected in fractioned doses following intermittent aspiration between the superior costotransverse ligament and the parietal pleura which will be displaced anteriorly by the injectate.
  • Similar approach will be used for the paravertebral block on the other side.
  • Sensory block over the area of surgical incision will be confirmed by loss of cold sensation using an alcohol swab and pinprick sensation using a 23 G gauge needle every 3 mint until 15 min after injection of the study solutions and before starting general anesthesia.

General Anesthesia:

General Anesthesia will be induced using intravenous propofol (2-3 mg/kg), fentanyl IV (1µ/kg) microgram/kilo and atracurium besylate (0.6 mg/kg) to facilitate intubation. Then patient will be mechanically ventilated using a volume control mode with Tv 6-8ml/kg, respiratory rate 10-14 breath/min and I.E. ratio 1:2 to maintain Etco2 35-40 mmHg mli mercury. Anesthesia will be maintained using minimum alveolar concentration of isoflurane 1.2% and 60% air in O2 mixture with top up dose of atracurium. Intraoperative IV fluids will be given per body weight and according to intraoperative loss.

All patients will be extubated at the end of surgery after neuromuscular reversal with administration of neostigmine (0.05 mg/kg) and IV atropine (0.02 mg/kg) and fulfilling the criteria of extubation. The duration of the surgery will be recorded.

Monitoring:

Intra-operative assessment

  • In operating room, monitoring will be achieved by five lead electro cardi gram, oxygen saturation and non-invasive mean arterial blood pressure.
  • Base line values of heart rate, oxygen saturation and non-invasive mean arterial blood pressure will be collected before and after paravertebral block, just after induction of anesthesia, at skin incision, then recording will be done every 15 mint till the end of the first hour and then every 30min interval till the end of surgery.
  • Sensory block onset will be defined when the patient subjectively evaluate the intensities of both cold and pinprick sensations in the blocked side decrease 75 % or more.
  • Duration of surgery will be defined as the time from induction to discharge from the operating room will be recorded.
  • In case of increased in intra-operative systolic blood pressure and heart rate of more than 20% of baseline for longer than 5min, incremental doses of fentanyl IV 0.5µ/kg will be given and the case will be excluded.

Postoperative Assessment:

  • On admission into the post operative care unit, all vital data & hemodynamics (non-invasive mean arterial blood pressure, heart rate, and oxygen saturation) will be recorded at 1, 2, 6, 12 and 24 hrs. postoperative
  • Post-operative complications will be recorded including post-operative nausea and vomiting treated by metoclopramide, hypotension treated by phenylephrine drops, bradycardia treated by atropine or pneumothorax, respiratory depression and chest pain, respiratory depression is defined as respiratory rate less than 8 per minute or oxygen saturation below 90%.

Statistical analysis The statistical analysis of data will be done by using excel program for figures and Statistical Package for Social Science program version 22. To test the normality of data distribution Kolmogorov- Smirnov test will be done only significant data revealed to be nonparametric. Unpaired student-t test will be used for comparisons of numerical variables between-group, if its assumptions were fulfilled, otherwise for non-parametric; the Mann-Whitney test will be used. The description of data done in the form of mean (±SD) stander division for quantitative data and frequency and proportion for qualitative data. Any difference or change showing probability (P) less than 0.05 will be considered statistically significant at confidence interval 95%.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

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.

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Prevention
Condition  ICMJE Laparoscopic Cholecystectomy
Intervention  ICMJE
  • Drug: Bupivacain
    local anesthetic agent
    Other Names:
    • Control group: Bupivacaine Group (B group
    • Saline
  • Drug: magnesium sulfate
    In the central nervous system , it has depressant effects, by antagonism at NMDA receptors and through inhibition of release of catecholamines
    Other Names:
    • Magnesium Group (M group)
    • saline
  • Other: saline
    medical solution
Study Arms  ICMJE
  • Placebo Comparator: Control group: Bupivacaine Group (B group)
    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
    Interventions:
    • Drug: Bupivacain
    • Other: saline
  • Active Comparator: Magnesium Group (M group)
    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.
    Interventions:
    • Drug: Bupivacain
    • Drug: magnesium sulfate
    • Other: saline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 18, 2021)
50
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 15, 2021
Actual Primary Completion Date September 10, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05099250
Other Study ID Numbers  ICMJE MS/18.01.12
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Marwa Ibrahim Mohamed Abdo,MD, Mansoura University
Study Sponsor  ICMJE Mansoura University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Ghada Fa Al-Rahamawy, MD Professor of Anesthesia - Intensive Care Faculty of Medicine - Mansoura University
Study Director: Hesham Ah Abdel Mohaiemn, MD Assistant Professor of Anesthesia - Intensive Care Faculty of Medicine - Mansoura University
Principal Investigator: 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
PRS Account Mansoura University
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP