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NCT Number: NCT03949452

Subcostal Transversus Abdominis Plane Versus Epidural Block in Abdominal Surgeries

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

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Key information

Conditions

Upper Abdominal Surgery

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University

Al Mansurah, DK, 050, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Subcostal Transversus Abdominis Plane catheter

Other

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.

Epidural catheter

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Comparative Study Between Subcostal Transversus Abdominis Plane Block Analgesia and Epidural Analgesia in Upper Abdominal Surgeries

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
May 14, 2019
Registry last updated
Sep 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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