Clinical trial NCT04138901: Postoperative Analgesic Effect of Subcostal TAPB for Laparoscopic Gastrectomy
Official title: Ultrasound-guided Subcostal Transversus Abdominis Plane Block in Gastric Cancer Patients Undergoing Laparoscopic Gastrectomy: A Randomized Controlled Double-blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Postoperative pain
Stomach neoplasms
Nerve block
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-10-25
Enrollment: 112
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: A prospective randomized double-blinded study
Primary purpose: TREATMENT

Brief summary: This prospective, randomized, single blinded study is designed to evaluate the postoperative analgesic efficacy of the ultrasound-guided subcostal transversus abdominis plane block in gastric cancer patients undergoing laparoscopic gastrectomy. We hypothesize that US guided subcostal TAP block with ropivacaine can significantly reduce postoperative opioid comparison in patients with laparoscopic gastrectomy.

Detailed description: Adult patients undergoing elective laparoscopic gastrectomy are randomly allocated to receive subcostal TAP block (n=56) or not (n=56), in addition to a standard postoperative analgesic regimen comprising of IV fentanyl-based patient-controlled analgesia (PCA) and NSAIDs as required. At the end of surgery, the TAP group patients will receive bilateral subcostal TAP block under ultrasound guidance with 15ml of 0.375% ropivacaine bilaterally. Each patient was assessed by a blinded investigator at 6, 12, 24, and 48 h postoperatively. The primary outcome is total fentanyl consumption at 24 h after surgery.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled to undergo elective laparoscopic gastrectomy under general anesthesia
* American Society of Anesthesiologists (ASA) physical classification I-III
* Consent to IV-patient controlled analgesia use
* Willingness and ability to sign an informed consent document

Exclusion Criteria:

* Do not understand our study
* Allergies to anesthetic or analgesic medications
* Wound infiltration analgesia for postoperative pain control
* Infection or anatomic abnormality at the needle insertion site
* Pregnancy/Breast feeder
* Medical or psychological disease that can affect the treatment response

Primary outcomes:
measure: Total fentanyl consumption during 24 hours
timeFrame: postoperative 24 hours
Secondary outcomes:
measure: Total fentanyl consumption
timeFrame: postoperative 6, 12, 48 hours
measure: Postoperative pain score
timeFrame: postoperative 6, 12, 24, 48 hours
measure: occurrence of opioid-related side effects
timeFrame: postoperative 6, 12, 24, 48 hours
measure: Rescue nonopioid(ketorolac, nefopam) analgesic requirement
timeFrame: postoperative 6, 12, 24, 48 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hojin Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: