Subcostal Transversus Abdominis Plane Versus Epidural Block in Abdominal Surgeries

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

Study Overview

• Status: Completed
• Conditions: Upper Abdominal Surgery
• Intervention / Treatment: Other: Subcostal Transversus Abdominis Plane catheter; Other: Epidural catheter

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.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • DK
    • Mansoura, DK, Egypt, 050
      • Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total morphine consumption	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.	For 72 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First request for rescue analgesia	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.	for 72 hours after surgery
Pain Scores	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.	up to 72 hours postoperatively
Heart rate	Heart rate will be assessed at 1, 2, 4, 8, 12, 24, 36, 48, 60 and 72 hours postoperatively.	for 72 hours postoperative
Mean arterial blood pressure	Mean arterial blood pressure will be assessed at 1, 2, 4, 8, 12, 24, 36, 48, 60 and 72 hours postoperatively.	for 72 hours postoperative
Peripheral oxygen saturation	Peripheral oxygen saturation will be assessed at 1, 2, 4, 8, 12, 24, 36, 48, 60 and 72 hours postoperatively.	for 72 hours postoperative
Nausea and vomiting	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.	up to 72 hours postoperatively
Degree of sedation	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	for 72 hours postoperative
Serum level of magnesium sulphate	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	up to 72 hours postoperatively
Patient satisfaction with their analgesia	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.	up to 72 hours postoperatively
Wound pain	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.	up to 3 months postoperatively

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: 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 and helpful links

General Publications

• Hebbard P. Subcostal transversus abdominis plane block under ultrasound guidance. Anesth Analg. 2008 Feb;106(2):674-5; author reply 675. doi: 10.1213/ane.0b013e318161a88f. No abstract available.
• Culebras X, Van Gessel E, Hoffmeyer P, Gamulin Z. Clonidine combined with a long acting local anesthetic does not prolong postoperative analgesia after brachial plexus block but does induce hemodynamic changes. Anesth Analg. 2001 Jan;92(1):199-204. doi: 10.1097/00000539-200101000-00038.

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2019
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: May 8, 2019
• First Submitted That Met QC Criteria: May 11, 2019
• First Posted (Actual): May 14, 2019

Study Record Updates

• Last Update Posted (Actual): September 11, 2020
• Last Update Submitted That Met QC Criteria: September 9, 2020
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: MD ∕ 17.12.104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available
• IPD Sharing Time Frame: data will be available within 6 monthes of study completion.
• IPD Sharing Access Criteria: Data may be shared by contacting the principle investegator.
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No