Clinical trial NCT03949452: Subcostal Transversus Abdominis Plane Versus Epidural Block in Abdominal Surgeries
Official title: Comparative Study Between Subcostal Transversus Abdominis Plane Block Analgesia and Epidural Analgesia in Upper Abdominal Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Abdominal Surgery
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2019-05-14
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind (participant, investigator) study
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: Total morphine consumption
timeFrame: For 72 hours after surgery
Secondary outcomes:
measure: First request for rescue analgesia
timeFrame: for 72 hours after surgery
measure: Pain Scores
timeFrame: up to 72 hours postoperatively
measure: Heart rate
timeFrame: for 72 hours postoperative
measure: Mean arterial blood pressure
timeFrame: for 72 hours postoperative
measure: Peripheral oxygen saturation
timeFrame: for 72 hours postoperative
measure: Nausea and vomiting
timeFrame: up to 72 hours postoperatively
measure: Degree of sedation
timeFrame: for 72 hours postoperative
measure: Serum level of magnesium sulphate
timeFrame: up to 72 hours postoperatively
measure: Patient satisfaction with their analgesia
timeFrame: up to 72 hours postoperatively
measure: Wound pain
timeFrame: up to 3 months postoperatively
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: DK
Study officials:
affiliation: Professor of Anesthesia and Surgical Intensive Care
name: Mohamed Y Makharita, MD
role: STUDY_CHAIR
affiliation: Assistant Professor of Anesthesia and Surgical Intensive Care
name: Hazem ES Moawad, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.