Subcostal Transversus Abdominis Plane Versus Epidural Block in Abdominal Surgeries

Not Applicable

Completed

• Conditions: Upper Abdominal Surgery
• Interventions: Other: Epidural catheter; Other: Subcostal Transversus Abdominis Plane catheter

• Registration Number: NCT03949452
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2019-05
• Study First Submitted: 2019-05-08
• Study Start: 2019-05-10
• Study First Submitted QC: 2019-05-11
• Study First Posted: 2019-05-14
• Primary Completion: 2019-11-01
• Study Completion: 2020-01-01
• Last Update Submitted: 2020-09-09
• Last Update Posted: 2020-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epidural catheter	Epidural catheter	This group includes patients who will receive epidural analgesia using a catheter technique
Subcostal Transversus Abdominis Plane catheter	Subcostal Transversus Abdominis Plane catheter	This group includes patients who will receive subcostal Transversus abdominis plane block analgesia

Primary Outcome Measures

Name	Time	Method
Total morphine consumption	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

Name	Time	Method
Pain Scores	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.
First request for rescue analgesia	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.
Heart rate	for 72 hours postoperative	Heart rate will be assessed at 1, 2, 4, 8, 12, 24, 36, 48, 60 and 72 hours postoperatively.
Mean arterial blood pressure	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.
Peripheral oxygen saturation	for 72 hours postoperative	Peripheral oxygen saturation will be assessed at 1, 2, 4, 8, 12, 24, 36, 48, 60 and 72 hours postoperatively.
Nausea and vomiting	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.
Degree of sedation	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
Serum level of magnesium sulphate	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
Patient satisfaction with their analgesia	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.
Wound pain	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.

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansoura, DK, Egypt