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This trial seeks to assess the efficacy of a superior hypogastric plexus block for early quality of recovery after laparoscopic colorectal cancer surgery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nerve block | Experimental | The superior hypogastric plexus block in this group will contain 20 mL of 0.75% ropivacaine hydrochloride. |
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| Placebo block | Placebo Comparator | The superior hypogastric plexus block in this group will contain 20 mL of 0.9% normal saline. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Superior hypogastric plexus block | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to postoperative day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to postoperative day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse events | Incidence of adverse events related to the plexus block (vascular puncture, hematoma, and local anesthetic systemic toxicity (LAST)) | Intraoperative (During block performance) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mengying Ding | Contact | +86-15170375679 | 15170375679@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Sixth Affiliated Hospital of Sun Yet-set University | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D004194 | Disease |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Postoperative Opioid Use | Postoperative opioid consumption during said time points | 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. | 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). | Up to postoperative day 90 |
| Length of stay in post-anesthesia care unit (PACU) area | Total time in PACU area | Postoperative day 1 |
| Postoperative nausea and vomiting | number of participants with nausea or vomiting | Up to postoperative day 2 |
| Length of hospital stay | The length of patient hospital stay will be supplemented through Hospital Information System after surgery. | Up to 3 months after surgery |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |