Colorectal Cancer (Diagnosis)SHIELDSNCT07579780
Superior HypogastrIc plExus bLock During Laparoscopic Colorectal Cancer Surgery
A study testing Superior hypogastric plexus block in people with Colorectal Cancer (Diagnosis) and Laparoscopic Surgery, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
This trial seeks to assess the efficacy of a superior hypogastric plexus block for early quality of recovery after laparoscopic colorectal cancer surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer (Diagnosis), Laparoscopic Surgery, Superior Hypogastric Plexus Block
- What is being tested?
- Superior hypogastric plexus block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2025to 18 Feb 2027
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide informed consent.
- Undergoing elective laparoscopic radical resection for colorectal cancer.
- American Society of Anesthesiologists Physical Status (ASA) class I-III.
Who cannot join
- Allergy to block medication (s).
- Coagulation dysfunction.
- Local or systemic infection.
- Unable to cooperate with the completion of the study protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Sixth Affiliated Hospital of Sun Yet-set University
Guangzhou, Guangdong, 510000
Mengying Ding, +86-15170375679, 15170375679@163.com
About this study
Official title: Superior Hypogastric Plexus Block for Early Recovery After Laparoscopic Colorectal Cancer Surgery: A Randomized Controlled Trial
This trial seeks to assess the efficacy of a superior hypogastric plexus block for early quality of recovery after laparoscopic colorectal cancer surgery.
Read the detailed description
This study is a single-center, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy of superior hypogastric plexus block (SHPB) in improving the quality of postoperative recovery in patients undergoing laparoscopic colorectal cancer surgery. A total of 170 eligible patients will be enrolled and randomly assigned in a 1:1 ratio to receive either SHPB or placebo block. The primary outcome is the 15-item Quality of Recovery (QoR-15) score at 24 hours postoperatively. Secondary outcomes include visceral pain numerical rating scale (NRS) scores at rest and during movement within 48 hours postoperatively, morphine consumption, time to first flatus, incidence of postoperative ileus, length of hospital stay, and inflammatory cytokine levels (such as interleukin-6 and C-reactive protein). This study aims to elucidate the evidence-based medical position of SHP block within the Enhanced Recovery After Surgery (ERAS) strategy for laparoscopic colorectal cancer surgery.
- Being tested
- Superior hypogastric plexus block
- Keywords
- Colorectal Cancer, laparoscopic surgery, superior hypogastric plexus block, Quality of recovery
- Medical subject headings
- Colorectal Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superior hypogastric plexus blockProcedure or surgery
After establishing pneumoperitoneum in laparoscopic colorectal cancer surgery, the superior hypogastric plexus block will be performed on all patients. The block will contain 20 mL of 0.75% ropivacaine hydrochloride or 0.9% normal saline. The injection will be performed by tenting the presacral peritoneum, aspirating with a laparoscopic needle-tip syringe to ensure extravascular placement, and injecting the block.
| Study group | Role | What they receive |
|---|---|---|
| Nerve block | Experimental | The superior hypogastric plexus block in this group will contain 20 mL of 0.75% ropivacaine hydrochloride. Receives: Procedure: Superior hypogastric plexus block |
| Placebo block | Placebo comparator | The superior hypogastric plexus block in this group will contain 20 mL of 0.9% normal saline. Receives: Procedure: Superior hypogastric plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of recovery
The Quality of recovery (QoR) 15, ranging from 0 (the worst) to 150 (the best), is a patient-reported outcome questionnaire that measures the quality of recovery after surgery.
Measured: Up to postoperative day 2
Secondary outcomes (7)
Postoperative Pain Scores
Pain reported according to a visual rating scale from 0 to 100 points (0= no pain and 100= worst imaginable pain), which details their pain level using Visual Analog Scale (VAS) pain scores from the Brief Pain Inventory (BPI). Pain is reported on a scale of 1 to 100, and a higher score indicates greater pain intensity.
Measured: Up to postoperative day 2
Postoperative Opioid Use
Postoperative opioid consumption during said time points
Measured: Up to postoperative day 2
The Brief Pain Inventory (BPI)
The Brief Pain Inventory (BPI) is a self-administered questionnaire to assess the severity of pain and the impact of pain on the patient's daily functions. The BPI gives two main scores: a pain severity score and a pain interference score. The pain severity score is calculated from the four items about pain intensity. Each item is rated from 0, no pain, to 10, pain as bad as you can imagine, and contributes with the same weight to the final score, ranging from 0 to 40. The pain interference score corresponds to the item on pain interference. The seven sub-items are rated from 0, does not interfere, to 10, completely interferes, and contributes with the same weight to the final score, ranging from 0 to 70.
Measured: Up to postoperative day 90
The McGill Pain Questionnaire
The Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) is an expanded and revised version of the original Short-Form McGill Pain Questionnaire (SF-MPQ), developed to provide a rapid, yet comprehensive, assessment of the multidimensional experience of pain. The main component of the SF-MPQ-2 consists of 22 descriptors rated on a Numeric Rating Scale, ranging from 0 (very dissatisfied) to 10 (very satisfied).
Measured: Up to postoperative day 90
Length of stay in post-anesthesia care unit (PACU) area
Total time in PACU area
Measured: Postoperative day 1
Postoperative nausea and vomiting
number of participants with nausea or vomiting
Measured: Up to postoperative day 2
Length of hospital stay
The length of patient hospital stay will be supplemented through Hospital Information System after surgery.
Measured: Up to 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start15 Dec 2025
- Primary completion18 Dec 2026 (estimated)
- Study completion18 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiangcai Ruan, MD, PhD, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579780
- Sponsor's protocol ID
- E2025271
- Acronym
- SHIELDS
- Status last verified
- Dec 2025
- First submitted
- 28 Apr 2026
- Last updated
- 12 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superior Hypogastric Plexus Block for Early Recovery After Laparoscopic Colorectal Cancer Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07579780
- Acronym / sponsor ID
- SHIELDS / E2025271
- Keywords
- Colorectal Cancer, laparoscopic surgery, superior hypogastric plexus block, Quality of recovery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 18 Dec 2026 (estimated)
- Study completion
- 18 Feb 2027 (estimated)
- First posted
- 12 May 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 trial seeks to assess the efficacy of a superior hypogastric plexus block for early quality of recovery after laparoscopic colorectal cancer surgery.
Detailed description
This study is a single-center, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy of superior hypogastric plexus block (SHPB) in improving the quality of postoperative recovery in patients undergoing laparoscopic colorectal cancer surgery. A total of 170 eligible patients will be enrolled and randomly assigned in a 1:1 ratio to receive either SHPB or placebo block. The primary outcome is the 15-item Quality of Recovery (QoR-15) score at 24 hours postoperatively. Secondary outcomes include visceral pain numerical rating scale (NRS) scores at rest and during movement within 48 hours postoperatively, morphine consumption, time to first flatus, incidence of postoperative ileus, length of hospital stay, and inflammatory cytokine levels (such as interleukin-6 and C-reactive protein). This study aims to elucidate the evidence-based medical position of SHP block within the Enhanced Recovery After Surgery (ERAS) strategy for laparoscopic colorectal cancer surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nerve block | Experimental | Procedure: Superior hypogastric plexus blockThe superior hypogastric plexus block in this group will contain 20 mL of 0.75% ropivacaine hydrochloride. |
| Placebo block | Placebo comparator | Procedure: Superior hypogastric plexus blockThe superior hypogastric plexus block in this group will contain 20 mL of 0.9% normal saline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to provide informed consent.
- Undergoing elective laparoscopic radical resection for colorectal cancer.
- American Society of Anesthesiologists Physical Status (ASA) class I-III.
Key exclusion criteria (4 listed)
- Allergy to block medication (s).
- Coagulation dysfunction.
- Local or systemic infection.
- Unable to cooperate with the completion of the study protocol.
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 |
|---|---|---|
| Superior hypogastric plexus blockAfter establishing pneumoperitoneum in laparoscopic colorectal cancer surgery, the superior hypogastric plexus block will be performed on all patients. The block will contain 20 mL of 0.75% ropivacaine hydrochloride or 0.9% normal saline. The injection will be performed by tenting the presacral peritoneum, aspirating with a laparoscopic needle-tip syringe to ensure extravascular placement, and injecting the block. | Procedure or surgery | Nerve block, Placebo block |
Primary outcome
Quality of recovery
Time frame: Up to postoperative day 2
The Quality of recovery (QoR) 15, ranging from 0 (the worst) to 150 (the best), is a patient-reported outcome questionnaire that measures the quality of recovery after surgery.
7 secondary outcomes
Postoperative Pain Scores
Time frame: Up to postoperative day 2
Postoperative Opioid Use
Time frame: Up to postoperative day 2
The Brief Pain Inventory (BPI)
Time frame: Up to postoperative day 90
The McGill Pain Questionnaire
Time frame: Up to postoperative day 90
Length of stay in post-anesthesia care unit (PACU) area
Time frame: Postoperative day 1
Postoperative nausea and vomiting
Time frame: Up to postoperative day 2
Length of hospital stay
Time frame: Up to 3 months after surgery
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 12 May 2026.
- Individual participant dataSharing planned: No
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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 study testing Superior hypogastric plexus block in people with Colorectal Cancer (Diagnosis) and Laparoscopic Surgery, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 12 May 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 China. 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.
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 Mengying Ding (+86-15170375679, 15170375679@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of recovery (time frame: Up to postoperative day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2026.