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NCT Number: NCT07579780

Superior HypogastrIc plExus bLock During Laparoscopic Colorectal Cancer Surgery

This trial seeks to assess the efficacy of a superior hypogastric plexus block for early quality of recovery after laparoscopic colorectal cancer surgery.

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Key information

Conditions

Colorectal Cancer (Diagnosis) Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Disease Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Laparoscopic Surgery Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Superior Hypogastric Plexus Block

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Sixth Affiliated Hospital of Sun Yet-set University

Guangzhou, Guangdong, 510000, China

Location status: Recruiting

Location contact

Mengying Ding

CONTACT

[email protected]

+86-15170375679

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Postoperative Pain Scores

    Time frame: Up to postoperative day 2

    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.

  2. Postoperative Opioid Use

    Time frame: Up to postoperative day 2

    Postoperative opioid consumption during said time points

  3. The Brief Pain Inventory (BPI)

    Time frame: Up to postoperative day 90

    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.

  4. The McGill Pain Questionnaire

    Time frame: Up to postoperative day 90

    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).

  5. Length of stay in post-anesthesia care unit (PACU) area

    Time frame: Postoperative day 1

    Total time in PACU area

  6. Postoperative nausea and vomiting

    Time frame: Up to postoperative day 2

    number of participants with nausea or vomiting

  7. Length of hospital stay

    Time frame: Up to 3 months after surgery

    The length of patient hospital stay will be supplemented through Hospital Information System after surgery.

Other outcomes

  1. Incidence of Adverse events

    Time frame: Intraoperative (During block performance)

    Incidence of adverse events related to the plexus block (vascular puncture, hematoma, and local anesthetic systemic toxicity (LAST))

Study contacts

Contact information is provided by the study sponsor or research team.

Mengying Ding

CONTACT

[email protected]

+86-15170375679

Sponsors and collaborators

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Other

Registry information

Official study title

Superior Hypogastric Plexus Block for Early Recovery After Laparoscopic Colorectal Cancer Surgery: A Randomized Controlled Trial

Acronym: SHIELDS

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 12, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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