Clinical trial NCT04920019: Opioid Sparing Effect of Thoracic Epidural Analgesia for Open Upper Abdominal Surgery
Official title: Opioid Sparing Effect of Thoracic Epidural Analgesia for Open Upper Abdominal Surgery: Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatoma
Pancreas Cancer
Keywords: open upper abdominal surgery
continuous epidural analgesia
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2021-06-09
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group A: continuous epidural analgesia, Group B: no continuous epidural analsesia
Primary purpose: TREATMENT

Brief summary: This prospective randomized controlled study is aimed to determine the advantages of thoracic epidural analgesia for open upper abdominal surgery in combination with multimodal analgesia compared with no thoracic epidural analgesia on postoperative pain control. The primary outcome is total opioid consumption in postoperative 72 hours. Secondary outcomes are the success of continuous epidural analgesia or complications of this technique, pain intensity, morbidity and mortality compare to no continuous epidural analgesia.

Detailed description: Continuous epidural analgesia (CEA) for open upper abdominal surgery has been showed the analgesic analgesia for open abdominal surgery. However the technical difficulty, complications especially hypotension, pruritus of CEA impede the popularity of technique compared to intravenous patient-controlled analgesia (IV PCA) in multimodal analgesia. This study is aimed to study of the role of CEA and multimodal analgesia in open abdominal surgery compare to IV PCA.

Eligibility criteria: Inclusion Criteria:

* age 18-80 years
* open upper abdominal surgery
* American Society of Anesthesiologists (ASA) grade I-III

Exclusion Criteria:

* contraindications to CEA
* inability communication
* patient's refusal
* emergency surgery
* BMI \> 35

Primary outcomes:
measure: Amount of postoperative opioid consumption
timeFrame: postoperative 24 hours
measure: Amount of postoperative opioid consumption
timeFrame: postoperative 48 hours
measure: Amount of postoperative opioid consumption
timeFrame: postoperative 72 hours
Secondary outcomes:
measure: Pain intensity
timeFrame: postoperative 6 hours until 72 hours postoperative
measure: Intraoperative opioid usage
timeFrame: intraoperative
measure: Complications of thoracic epidural analgesia
timeFrame: postoperative 24 hours, 48 hours, 72 hours
measure: Percentage of patient to do out of bed activities
timeFrame: postoperative day 1
measure: Length of hospital stay
timeFrame: days from patient admission until discharge, an average within 1 week
measure: Morbidity
timeFrame: Up to 30 days postoperative
measure: Mortality
timeFrame: Up to 30 days postoperative
Other outcomes:
Locations:
city: Bangkok Noi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital, Mahidol University
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Suwimon Tangwiwat, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guay J, Nishimori M, Kopp SL. Epidural Local Anesthetics Versus Opioid-Based Analgesic Regimens for Postoperative Gastrointestinal Paralysis, Vomiting, and Pain After Abdominal Surgery: A Cochrane Review. Anesth Analg. 2016 Dec;123(6):1591-1602. doi: 10.1213/ANE.0000000000001628.
citation: Salicath JH, Yeoh EC, Bennett MH. Epidural analgesia versus patient-controlled intravenous analgesia for pain following intra-abdominal surgery in adults. Cochrane Database Syst Rev. 2018 Aug 30;8(8):CD010434. doi: 10.1002/14651858.CD010434.pub2.
citation: Greco KJ, Brovman EY, Nguyen LL, Urman RD. The Impact of Epidural Analgesia on Perioperative Morbidity or Mortality after Open Abdominal Aortic Aneurysm Repair. Ann Vasc Surg. 2020 Jul;66:44-53. doi: 10.1016/j.avsg.2019.10.054. Epub 2019 Oct 28.
citation: Simpson RE, Fennerty ML, Colgate CL, Kilbane EM, Ceppa EP, House MG, Zyromski NJ, Nakeeb A, Schmidt CM. Post-Pancreaticoduodenectomy Outcomes and Epidural Analgesia: A 5-year Single-Institution Experience. J Am Coll Surg. 2019 Apr;228(4):453-462. doi: 10.1016/j.jamcollsurg.2018.12.038. Epub 2019 Jan 21.
citation: Groen JV, Khawar AAJ, Bauer PA, Bonsing BA, Martini CH, Mungroop TH, Vahrmeijer AL, Vuijk J, Dahan A, Mieog JSD. Meta-analysis of epidural analgesia in patients undergoing pancreatoduodenectomy. BJS Open. 2019 Apr 29;3(5):559-571. doi: 10.1002/bjs5.50171. eCollection 2019 Oct.