Subcostal Transversus Abdominis Plane Versus Epidural Block in Abdominal Surgeries

NCT03949452 | Completed DMC

• 1 other identifier: MD ∕ 17.12.104
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Abdominal Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• First request for rescue analgesia

  for 72 hours after surgery

• Pain Scores

  up to 72 hours postoperatively

• Heart rate

  for 72 hours postoperative

• Mean arterial blood pressure

  for 72 hours postoperative

• Peripheral oxygen saturation

  for 72 hours postoperative

Study Arms (2)

Subcostal Transversus Abdominis Plane catheter

ACTIVE COMPARATOR

This group includes patients who will receive subcostal Transversus abdominis plane block analgesia

Other: Subcostal Transversus Abdominis Plane catheter

Epidural catheter

PLACEBO COMPARATOR

This group includes patients who will receive epidural analgesia using a catheter technique

Other: Epidural catheter

Interventions

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.

Subcostal Transversus Abdominis Plane catheter

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.

Epidural catheter

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, DK, 050, Egypt

Location

Related Publications (2)

• 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.

  PMID: 18227342 RESULT

• 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.

  PMID: 11133627 RESULT

Study Officials

• Mohamed Y Makharita, MD

  Professor of Anesthesia and Surgical Intensive Care

  STUDY CHAIR

• Hazem ES Moawad, MD

  Assistant Professor of Anesthesia and Surgical Intensive Care

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blind (participant, investigator) study

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 14, 2019
• Study Start: May 10, 2019
• Primary Completion: November 1, 2019
• Study Completion: January 1, 2020
• Last Updated: September 11, 2020

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

EG (1)