Rectus Sheath BlockPhase 4NCT07624916
Transversus Abdominis Plane and Rectus Sheath Block for Robotic Colectomy
A Phase 4 study testing Ropivacaine and Saline in people with Rectus Sheath Block and Transversus Abdominis Plane Block, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial summary
This study aimed to evaluate the impact of ultrasound-guided bilateral transversus abdominis plane block combined with rectus sheath block on postoperative pain and recovery after robotic colectomy under an enhanced recovery after surgery (ERAS) protocol. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Rectus Sheath Block, Transversus Abdominis Plane Block, Enhanced Recovery After Surgery
- What is being tested?
- Ropivacaine and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2026to 31 Mar 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective robotic colorectal cancer surgery for the first time
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Tri-Service General Hospital
Taipei
Wei-Cheng Tseng, MD, 886-2-8792-3311 ext. 24159, ndmc_wechern@yahoo.com.tw
About this study
Official title: Impact of Transversus Abdominis Plane Block Combined With Rectus Sheath Block on Postoperative Pain Management in Patients Undergoing Elective Robotic Colectomy
This study aimed to evaluate the impact of ultrasound-guided bilateral transversus abdominis plane block combined with rectus sheath block on postoperative pain and recovery after robotic colectomy under an enhanced recovery after surgery (ERAS) protocol.
Read the 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.
- Conditions
- Rectus Sheath Block, Transversus Abdominis Plane Block, Enhanced Recovery After Surgery, Robotic Surgery, Colorectal Cancer
- Being tested
- Ropivacaine, Saline
- Keywords
- colorectal cancer, robotic colectomy, enhanced recovery after surgery, transversus abdominis plane block, rectus sheath block
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
TAP+RS block using ropivacaine
SalineDrug
TAP+RS block with saline
| Study group | Role | What they receive |
|---|---|---|
| TAP+RSB-R group | Experimental | TAP+RS block with ropivacaine and standard analgesic care Receives: Drug: Ropivacaine |
| TAP+RSB-S group | Placebo comparator | TAP+RS block with saline and standard analgesic care Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale at Resting
Measured: Postoperative 48 hours
Visual Analogue Scale at Movement
Measured: Postoperative 48 hours
Postoperative Opioid Consumption
Measured: Postoperative 48 hours
Secondary outcomes (4)
Postoperative Adverse Event
Measured: From surgery until hospital discharge
Time to First Ambulation
Measured: From surgery until hospital discharge
Time to First Flatus
Measured: From surgery until hospital discharge
Hospital Stay
Measured: At hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Rectus Sheath BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei-Cheng Tseng, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07624916
- Sponsor's protocol ID
- C202605053
- Status last verified
- May 2026
- First submitted
- 24 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share
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.
PubMed 37379171Liu 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.
PubMed 35953018Viderman 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.
PubMed 35295183Liu 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.
PubMed 29402875Hain 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.
PubMed 29381824
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Transversus Abdominis Plane Block Combined With Rectus Sheath Block on Postoperative Pain Management in Patients Undergoing Elective Robotic Colectomy
- ClinicalTrials.gov ID
- NCT07624916
- Acronym / sponsor ID
- C202605053
- Conditions
- Rectus Sheath Block, Transversus Abdominis Plane Block, Enhanced Recovery After Surgery, Robotic Surgery, Colorectal Cancer
- Keywords
- colorectal cancer, robotic colectomy, enhanced recovery after surgery, transversus abdominis plane block, rectus sheath block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to evaluate the impact of ultrasound-guided bilateral transversus abdominis plane block combined with rectus sheath block on postoperative pain and recovery after robotic colectomy under an enhanced recovery after surgery (ERAS) protocol.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP+RSB-R group | Experimental | Drug: RopivacaineTAP+RS block with ropivacaine and standard analgesic care |
| TAP+RSB-S group | Placebo comparator | Drug: SalineTAP+RS block with saline and standard analgesic care |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for elective robotic colorectal cancer surgery for the first time
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RopivacaineTAP+RS block using ropivacaine | Drug | TAP+RSB-R group |
| SalineTAP+RS block with saline | Drug | TAP+RSB-S group |
Primary outcome
Visual Analogue Scale at Resting
Time frame: Postoperative 48 hours
Visual Analogue Scale at Movement
Time frame: Postoperative 48 hours
Postoperative Opioid Consumption
Time frame: Postoperative 48 hours
4 secondary outcomes
Postoperative Adverse Event
Time frame: From surgery until hospital discharge
Time to First Ambulation
Time frame: From surgery until hospital discharge
Time to First Flatus
Time frame: From surgery until hospital discharge
Hospital Stay
Time frame: At hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Results publication: PubMed 37379171Yang 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.
- Results publication: PubMed 35953018Liu 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.
- Results publication: PubMed 35295183Viderman 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.
- Results publication: PubMed 29402875Liu 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.
- Results publication: PubMed 29381824Hain 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.
- Individual participant dataSharing planned: No. There is no plan to share
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine and Saline in people with Rectus Sheath Block and Transversus Abdominis Plane Block, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei-Cheng Tseng, MD (886-2-8792-3311 ext. 24159, ndmc_wechern@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale at Resting (time frame: Postoperative 48 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07624916, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.