- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07624916
Transversus Abdominis Plane and Rectus Sheath Block for Robotic Colectomy
Impact of Transversus Abdominis Plane Block Combined With Rectus Sheath Block on Postoperative Pain Management in Patients Undergoing Elective Robotic Colectomy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Postoperative pain remains an important concern after robotic colectomy despite the implementation of enhanced recovery after surgery (ERAS) protocols. Although robotic colectomy is associated with smaller incisions and faster recovery than conventional open surgery, postoperative pain may still impair early ambulation, gastrointestinal recovery, and patient satisfaction. Multimodal analgesia strategies, including acetaminophen and nonsteroidal anti-inflammatory drugs, are commonly used in ERAS pathways to reduce opioid consumption and opioid-related adverse effects. However, postoperative pain during movement and opioid requirements remain clinically relevant issues.
Ultrasound-guided transversus abdominis plane (TAP) block has been reported to reduce postoperative pain and opioid consumption after colorectal surgery. In addition, rectus sheath block (RSB) may provide further analgesic benefit for midline abdominal incision pain. Nevertheless, the additional clinical benefit of combining TAP block and RSB in patients undergoing robotic colectomy within an established ERAS pathway has not been fully investigated.
This study aimed to evaluate the impact of ultrasound-guided bilateral TAP block combined with RSB on postoperative pain and recovery following robotic colectomy. Additionally, we investigated the influence of TAP block combined with RSB on postoperative opioid consumption, postoperative nausea and vomiting, early ambulation, gastrointestinal recovery, and length of hospital stay after robotic colectomy under ERAS management.
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Wei-Cheng Tseng, MD
- Phone Number: 24159 886-2-8792-3311
- Email: ndmc_wechern@yahoo.com.tw
Study Locations
-
-
-
Taipei, Taiwan
- Tri-Service General Hospital
-
Contact:
- Wei-Cheng Tseng, MD
- Phone Number: 24159 886-2-8792-3311
- Email: ndmc_wechern@yahoo.com.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients scheduled for elective robotic colorectal cancer surgery for the first time
Exclusion Criteria:
- Age < 18 years or age > 80 years
- Allergic to any medication in the protocol
- Infection over the injection site
- Chronic pain history
- Severe hepatic or renal insufficiency
- Pregnancy
- Emergency surgery
- Refusal to join the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: TAP+RSB-R group
TAP+RS block with ropivacaine and standard analgesic care
|
TAP+RS block using ropivacaine
|
|
Placebo Comparator: TAP+RSB-S group
TAP+RS block with saline and standard analgesic care
|
TAP+RS block with saline
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Visual Analogue Scale at Resting
Time Frame: Postoperative 48 hours
|
Postoperative 48 hours
|
|
Visual Analogue Scale at Movement
Time Frame: Postoperative 48 hours
|
Postoperative 48 hours
|
|
Postoperative Opioid Consumption
Time Frame: Postoperative 48 hours
|
Postoperative 48 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Postoperative Adverse Event
Time Frame: From surgery until hospital discharge
|
From surgery until hospital discharge
|
|
Time to First Ambulation
Time Frame: From surgery until hospital discharge
|
From surgery until hospital discharge
|
|
Time to First Flatus
Time Frame: From surgery until hospital discharge
|
From surgery until hospital discharge
|
|
Hospital Stay
Time Frame: At hospital discharge
|
At hospital discharge
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Yang R, Wang J, Shi DW, Niu Y, Zhou XD, Liu Y, Xu GH. The Efficiency of Multipoint Rectus Sheath Block Based on Incision Location in Laparoscopic-Assisted Colorectal Surgery: A Randomized Clinical Trial. Dis Colon Rectum. 2023 Dec 1;66(12):1578-1586. doi: 10.1097/DCR.0000000000002895. Epub 2023 Jun 28.
- Liu KY, Lu YJ, Lin YC, Wei PL, Kang YN. Transversus abdominis plane block for laparoscopic colorectal surgery: A meta-analysis of randomised controlled trials. Int J Surg. 2022 Aug;104:106825. doi: 10.1016/j.ijsu.2022.106825. Epub 2022 Aug 8.
- Viderman D, Aubakirova M, Abdildin YG. Transversus Abdominis Plane Block in Colorectal Surgery: A Meta-Analysis. Front Med (Lausanne). 2022 Feb 23;8:802039. doi: 10.3389/fmed.2021.802039. eCollection 2021.
- Liu L, Xie YH, Zhang W, Chai XQ. Effect of Transversus Abdominis Plane Block on Postoperative Pain after Colorectal Surgery: A Meta-Analysis of Randomized Controlled Trials. Med Princ Pract. 2018;27(2):158-165. doi: 10.1159/000487323. Epub 2018 Feb 1.
- Hain E, Maggiori L, Prost A la Denise J, Panis Y. Transversus abdominis plane (TAP) block in laparoscopic colorectal surgery improves postoperative pain management: a meta-analysis. Colorectal Dis. 2018 Apr;20(4):279-287. doi: 10.1111/codi.14037.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Intestinal Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colonic Diseases
- Colorectal Neoplasms
- Organic Chemicals
- Anilides
- Amides
- Aniline Compounds
- Amines
- Inorganic Chemicals
- Chlorine Compounds
- Sodium Compounds
- Chlorides
- Hydrochloric Acid
- Ropivacaine
- Sodium Chloride
Other Study ID Numbers
- C202605053
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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