Superior HypogastrIc plExus bLock During Laparoscopic Colorectal Cancer Surgery (SHIELDS)

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.

Study Overview

• Status: Recruiting
• Conditions: Laparoscopic Surgery; Superior Hypogastric Plexus Block; Colorectal Cancer (Diagnosis)
• Intervention / Treatment: Procedure: Superior hypogastric plexus block

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 Type: Interventional
• Enrollment (Estimated): 170
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mengying Ding; Phone Number: +86-15170375679; Email: 15170375679@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • The Sixth Affiliated Hospital of Sun Yet-set University
      • Contact: Mengying Ding; Phone Number: +86-15170375679; Email: 15170375679@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Able to provide informed consent.
• Undergoing elective laparoscopic radical resection for colorectal cancer.
• American Society of Anesthesiologists Physical Status (ASA) class I-III.

Exclusion Criteria:

• Allergy to block medication (s).
• Coagulation dysfunction.
• Local or systemic infection.
• Unable to cooperate with the completion of the study protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo block; The superior hypogastric plexus block in this group will contain 20 mL of 0.9% normal saline.	Procedure: Superior hypogastric plexus block; 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.
Experimental: Nerve block; The superior hypogastric plexus block in this group will contain 20 mL of 0.75% ropivacaine hydrochloride.	Procedure: Superior hypogastric plexus block; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
Postoperative Opioid Use	Postoperative opioid consumption during said time points	Up to postoperative day 2
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
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 hospital stay	The length of patient hospital stay will be supplemented through Hospital Information System after surgery.	Up to 3 months after surgery

Other Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2025
• Primary Completion (Estimated): December 18, 2026
• Study Completion (Estimated): February 18, 2027

Study Registration Dates

• First Submitted: April 28, 2026
• First Submitted That Met QC Criteria: May 5, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Colorectal Cancer; laparoscopic surgery; Quality of recovery; superior hypogastric plexus block
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Disease
• Other Study ID Numbers: E2025271

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No