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Subcostal Transversus Abdominis Plane Versus Epidural Block in Abdominal Surgeries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03949452
Recruitment Status : Completed
First Posted : May 14, 2019
Last Update Posted : September 11, 2020
Sponsor:
Information provided by (Responsible Party):
Mansoura University

Brief Summary:
The investegators aimed to compare the efficacy of subcostal Transversus abdominis plane analgesia, to epidural analgesia intra and postoperatively in upper abdominal surgeries.

Condition or disease Intervention/treatment Phase
Upper Abdominal Surgery Other: Subcostal Transversus Abdominis Plane catheter Other: Epidural catheter Not Applicable

Detailed Description:

Epidural analgesia, once considered the gold standard for major abdominal surgeries, but is often associated with sympathetic blockade that creates hypotension and could therefore adversely affect the conduit. Epidural analgesia is recently replaced by other techniques with an improved risk benefit ratio. Pain management techniques that use peripheral nerve blockade are becoming more prevalent, reducing the need for an epidural. Transversus abdominis plane (TAP) approach is aimed to access the nerves in this neurofacial plane between internal oblique muscle and transversus abdominis through the lumbar triangle of Petit. Subcostal Transversus abdominis plane block, has been reported to provide analgesia for incisions extending above the umbilicus. However, there have been few clinical trials on the analgesic efficacy of continuous subcostal Transversus abdominis plane analgesia after major abdominal surgeries. It has been reported recently that supplemental magnesium has a role in providing perioperative analgesia, because this is a relatively harmless molecule, not expensive and because the biological basis for its potential antinociceptive effect is promising. No clinical studies have examined the effect of magnesium sulphate administered continuously in subcostal Transversus abdominis plane catheters as an adjunct to bupivacaine in postoperative analgesia.

The aim of this study is to compare the efficacy of subcostal Transversus abdominis plane analgesia, to epidural analgesia in major upper abdominal surgeries.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blind (participant, investigator) study
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Comparative Study Between Subcostal Transversus Abdominis Plane Block Analgesia and Epidural Analgesia in Upper Abdominal Surgeries
Actual Study Start Date : May 10, 2019
Actual Primary Completion Date : November 1, 2019
Actual Study Completion Date : January 1, 2020

Arm Intervention/treatment
Active Comparator: Subcostal Transversus Abdominis Plane catheter
This group includes patients who will receive subcostal Transversus abdominis plane block analgesia
Other: Subcostal Transversus Abdominis Plane catheter

Prior to surgery, an ultrasound guided unilateral Subcostal Transversus abdominis plane bolus dose (consisting of amixture of 10 ml bupivaccaine 0.5% plus 100 mg magnesium sulphate to be completed by normal saline to a total volume of 20 ml mixture) will be given on the same side of the surgical incision.

At the end of surgery, A Transversus abdominis plane catheter will be inserted unilaterally by surgeon during wound closure. Then postoperatively, Transversus abdominis plane infusion of a solution mixture prepared in multiple 50 cm syringes each syringe contain 20 ml bupivacaine 0.5% plus 100 mg magnesium sulphate to be balanced by normal saline to 50 ml solution mixture ( final concentration of bupivacaine is 0.2%). This solution mixture will be infused through Transversus abdominis plane catheter at a rate of 6 ml/hour for 72 hours postoperatively.


Placebo Comparator: Epidural catheter
This group includes patients who will receive epidural analgesia using a catheter technique
Other: Epidural catheter

Prior to surgery, we will site an epidural catheter in the thoracic T7-T9 region, and inject an epidural bolus dose same as described above (consisting of amixture of 10 ml bupivaccaine 0.5% plus 100 mg magnesium sulphate to be completed by normal saline to a total volume of 20 ml mixture) for intra operative analgesia.

Postoperatively, patients will receive epidural infusion of the solution mixture (same as described above) prepared in multiple 50 cm syringes each syringe contain 20 ml bupivaccaine 0.5% plus 100 mg magnesium sulphate to be balanced by normal saline to 50 ml solution mixture ( final concentration of bupivaccaine is 0.2%). This solution mixture will be infused epidurally at a rate of 6 ml/hour for 72 hours (3 days) postoperatively.





Primary Outcome Measures :
  1. Total morphine consumption [ Time Frame: For 72 hours after surgery ]
    Intravenous morphine in adose of 0.05 mg/kg will be given if Visual Analogue Scale (VAS) is more than 30 mm in both groups and can be repeated every 15 minutes till Visual Analogue Scale become less than 3. Morphine administration will be ceased when the Visual Analogue Scale score <30 mm on assessment or when over-sedation or respiratory depression occurred (a respiratory rate of < 10 bpm). Doses given will be calculated daily and recorded.


Secondary Outcome Measures :
  1. First request for rescue analgesia [ Time Frame: for 72 hours after surgery ]
    First time patient ask for analgesia: in the post anesthesia care unit (PACU) will be recorded and morphine in a dose of 0.05 mg/kg will be given and the time recorded.

  2. Pain Scores [ Time Frame: up to 72 hours postoperatively ]
    • Presence and severity of pain will be assessed in All patients during rest and coughing using visual analogue scale (VAS).
    • Visual analogue scale (VAS) ranging from 0 to 10 while 0 as no pain and 10 as worst imaginable pain.
    • Presence and severity of pain will be assessed at 1, 2, 4, 8, 12, 24, 36, 48, 60 and 72 hours postoperatively.

  3. Heart rate [ Time Frame: for 72 hours postoperative ]
    Heart rate will be assessed at 1, 2, 4, 8, 12, 24, 36, 48, 60 and 72 hours postoperatively.

  4. Mean arterial blood pressure [ Time Frame: for 72 hours postoperative ]
    Mean arterial blood pressure will be assessed at 1, 2, 4, 8, 12, 24, 36, 48, 60 and 72 hours postoperatively.

  5. Peripheral oxygen saturation [ Time Frame: for 72 hours postoperative ]
    Peripheral oxygen saturation will be assessed at 1, 2, 4, 8, 12, 24, 36, 48, 60 and 72 hours postoperatively.

  6. Nausea and vomiting [ Time Frame: up to 72 hours postoperatively ]
    Nausea and vomiting: will be assessed through nausea scores (none = 0, mild = 1, moderate = 2 and vomiting = 3) at 1, 2, 4, 8, 12, 24, 36, 48, 60,72 hrs post operativly. We offered rescue antiemetics to any patient who had a nausea score of 2 or more.

  7. Degree of sedation [ Time Frame: for 72 hours postoperative ]

    Degree of sedation will be assessed by using the sedation scale described by Culebras (2001) as:

    • 1 : Awake and alert,
    • 2 : Sedated, responding to verbal stimulus,
    • 3 : Sedated, responding to mild physical stimulus,
    • 4 : Sedated, responding only to moderate or severe physical stimulus

    Degree of sedation will be assessed at 1, 2, 4, 8, 12, 24, 36, 48, 60 and 72 hours postoperatively


  8. Serum level of magnesium sulphate [ Time Frame: up to 72 hours postoperatively ]

    Degree of sedation will be assessed by using the sedation scale described by Culebras (2001) as:

    • 1 : Awake and alert,
    • 2 : Sedated, responding to verbal stimulus,
    • 3 : Sedated, responding to mild physical stimulus,
    • 4 : Sedated, responding only to moderate or severe physical stimulus

    Degree of sedation will be assessed at 1, 2, 4, 8, 12, 24, 36, 48, 60 and 72 hours postoperatively


  9. Patient satisfaction with their analgesia [ Time Frame: up to 72 hours postoperatively ]
    • Patient satisfaction with their analgesia will be assessed as (poor = 1, fair = 2, good = 3, excellent = 4).
    • Patient satisfaction with their analgesia will be assessed at 24, 48 and 72 hours post operatively.

  10. Wound pain [ Time Frame: up to 3 months postoperatively ]
    • Residual or chronic wound pain will be assessed in All patients using visual analogue scale (VAS).
    • Visual analogue scale (VAS) ranging from 0 to 10 while 0 as no pain and 10 as worst imaginable pain.
    • Residual wound pain will be assessed at 30, 60, 90 days postoperatively.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) physical status I, II or III
  • The incision included is right subcostal incision for major upper abdominal surgeries (partial hepatectomy, pancreatic surgery included Whipple's procedure, total pancreatectomy and distal pancreatectomy) and other operations using the same incision.

Exclusion Criteria:

  • Patient refusal.
  • Hematological diseases.
  • Bleeding diseases.
  • Coagulation abnormality.
  • Local skin infection
  • Sepsis at site of the block.
  • Known hypersensitivity to the study drugs.
  • Body Mass Index > 35 Kg/m2.
  • If the lower end of the incision extended below T10 (umbilicus).
  • If the incision extended laterally beyond the anterior axillary line or extended to pass the midline to the other side.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03949452


Locations
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Egypt
Mansoura University
Mansoura, DK, Egypt, 050
Sponsors and Collaborators
Mansoura University
Investigators
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Study Chair: Mohamed Y Makharita, MD Professor of Anesthesia and Surgical Intensive Care
Study Director: Hazem ES Moawad, MD Assistant Professor of Anesthesia and Surgical Intensive Care
Publications of Results:
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Responsible Party: Mansoura University
ClinicalTrials.gov Identifier: NCT03949452    
Other Study ID Numbers: MD ∕ 17.12.104
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: September 11, 2020
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available
Supporting Materials: Study Protocol
Time Frame: data will be available within 6 monthes of study completion.
Access Criteria: Data may be shared by contacting the principle investegator.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No