Postoperative Analgesic Effect of Subcostal TAPB for Laparoscopic Gastrectomy

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04138901
• Collaborator: (none)
• Enrollment: 112
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.1
• Patients Per Site Per Month: 15.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Procedure: Ultrasound guided subcostal transversus abdominis plane block (TAPB); Drug: Ropivacaine 0.75% Injectable Solution; Device: 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France)	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 112 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A prospective randomized double-blinded studyA prospective randomized double-blinded study
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: We plan to perform TAPB in patients under general anesthesia. Physicians not involved in this study will investigate the outcomes.
• Primary Purpose: Treatment
• Official Title: Ultrasound-guided Subcostal Transversus Abdominis Plane Block in Gastric Cancer Patients Undergoing Laparoscopic Gastrectomy: A Randomized Controlled Double-blinded Study
• Actual Study Start Date: Nov 4, 2019
• Actual Primary Completion Date: May 30, 2020
• Actual Study Completion Date: Jun 7, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group T Patients receiving bilateral subcostal TAP block.	Procedure: Ultrasound guided subcostal transversus abdominis plane block (TAPB); At the end of surgery, an anesthesiologist will perform bilateral subcostal TAP block with 0.375% ropivacaine 15ml at each site under ultrasound guidance.; Other Names: TAP block ; Drug: Ropivacaine 0.75% Injectable Solution; 0.375% ropivacaine is injected to the transversus abdominis plane via 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France); Device: 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France); 0.375% ropivacaine is injected to the transversus abdominis plane via 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France)
No Intervention: Group C Patients not receiving bilateral subcostal TAP block.

Outcome Measures

Primary Outcome Measures

1. Total fentanyl consumption during 24 hours [postoperative 24 hours]

   postoperative cumulative fentanyl consumption (mcg)

Secondary Outcome Measures

1. Total fentanyl consumption [postoperative 6, 12, 48 hours]

   postoperative cumulative fentanyl consumption (mcg)

2. Postoperative pain score [postoperative 6, 12, 24, 48 hours]

   11-pointed NRS pain score at resting/coughing NRS (0-10): 0, "no pain"; 10, "worst pain imaginable"

3. occurrence of opioid-related side effects [postoperative 6, 12, 24, 48 hours]

   Incidence of postoperative nausea and vomiting, dizziness, sedation, respiratory depression (%)

4. Rescue nonopioid(ketorolac, nefopam) analgesic requirement [postoperative 6, 12, 24, 48 hours]

   Overall postoperative rescue of nonopoioid(ketorolac, nefopam) analgesic requirement

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	KS013

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

• Principal Investigator: Hojin Lee, MD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hojin Lee, MD, Clinical assistant professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT04138901
• Other Study ID Numbers: HS-2019-01
• First Posted: Oct 25, 2019
• Last Update Posted: Aug 13, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hojin Lee, MD, Clinical assistant professor, Seoul National University Hospital: Postoperative pain; Stomach neoplasms; Nerve block
• Additional relevant MeSH terms: Pain, Postoperative; Ropivacaine

Study Results

No Results Posted as of Aug 13, 2020