The Impact of Methylene Blue on the Quality of Recovery in Patients Undergoing Hemorrhoidectomy

NCT06747195 | Recruiting DMC

• 1 other identifier: Kyll-202405（ZX）-041-3
• Study Type: observational
• Target: 290
• Locations: 1 country
• Sites: 3

Brief Summary

Classical hemorrhoidectomy is known to be linked with significant postoperative pain, which can result in patient discomfort, extended hospital stays, and increased costs. The Quality of Recovery (QOR) score serves as an objective measure of patient-centered general health status following surgery and anesthesia. The latest version, QOR-15, is known for its time-efficiency, high rate of response, and completion, and has been validated in patients undergoing a range of surgical procedures. Methylene blue (MB) is a water-soluble thiazine dye used to treat various conditions and has been found to have a unique analgesic property through the temporary disruption of anal sensory nerve terminals in patients. Studies conducted in Singapore and China have shown that perianal intradermal injection of MB provides temporary pain relief after hemorrhoidectomy and lateral anal sphincterotomy. However, there is limited published information regarding the impact of MB on the quality of recovery in anorectal surgery. This study aims to evaluate the effect of intradermal MB combined with ropivacaine injection on the quality of recovery for patients undergoing hemorrhoidectomy. Study population Patients with symptomatic third- and fourth-degree hemorrhoids who are undergoing hemorrhoidectomy under spinal anesthesia and are admitted to the hospitals (145 for each group) will be prospectively enrolled in this study. Before participating, all patients or their caregivers will provide written informed consent. The protocol for this study has been approved by the Ethical Committee of Qilu Hospital of Shandong University with the protocol number Kyll-202405-041-2. Intervention A standardized spinal anesthesia technique will be utilized, and between 7-9 mg of ropivacaine (Shijiazhuang Siyao Co., Ltd, 10ml:100mg) will be intrathecally injected between the L3 through L5 intervertebral spaces. All patients will undergo hemorrhoidectomy by colorectal surgeons with senior professional titles according to standard techniques. The postoperative analgesia regimen, with or without MB (Jichuan Pharmaceutical Group Co., LTD., 2ml: 20mg), will be determined at the discretion of the colorectal surgeon. Data collection Clinical data, including age, sex, acute complications and total hospitalization cost, will be collected from the enrolled patients. The QOR-15 score will be calculated for all patients. Over a 6-month follow-up period, complications and the Wexner score for postoperative fecal incontinence will be recorded through telephone interviews. Outcome measures The primary goal of this study is to evaluate the quality of recovery using the QOR-15 questionnaire, a comprehensive measure of recovery after surgery that assesses five dimensions: physical comfort (5 items), physical independence (2 items), emotional state (4 items), psychological support (2 items), and pain (2 items). Each item is rated on an 11-point scale based on its frequency on the questionnaire (higher scores indicate greater frequency for positive items and less frequency for negative items). The total score ranges from 0 (poorest recovery quality) to 150 (best recovery quality). Patients will complete the QOR-15 questionnaire at three time points: the day before surgery, postoperative day 1, and postoperative day 2 (between 4 pm and 6 pm). The postoperative day 1 score is the primary outcome of interest. Additional assessments included the following: The study will collect data on the Visual Analogue Score of pain at multiple time points (postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 7, postoperative day 14), total hospitalization costs, dosage of analgesics three days and fourteen days after surgery, pain leading to unscheduled hospital returns or stay, and various complications such as urinary retention, fecal incontinence, itch and perianal paresthesia, secondary bleeding, perianal infection, poor wound healing at different postoperative time points (postoperative day 1, postoperative day, 1 month postoperative, 3 months postoperative, 6 months postoperative). Additionally, the Wexner score for postoperative fecal incontinence will be recorded at 1 month and 3 months postoperative.

Conditions

Hemorrhoidectomy; Postoperative Analgesia

Keywords

Hemorrhoidectomy; Methylene blue; Quality of recovery; Analgesia; Prospective Cohort Study

Outcome Measures

Primary Outcomes (1)

• The Quality of Recovery-15 score on postoperative day 1

  The Quality of Recovery-15 questionnaire, which is a comprehensive measure of recovery after surgery. The QOR-15 evaluates five dimensions of recovery: physical comfort, physical independence, emotional state, psychological support, and pain. Each dimension consists of a different number of items, and each item is rated on an 11-point scale based on the frequency of the experience reported. A higher score indicates a higher frequency for positive items and a lower frequency for negative items. The total score ranges from 0 (indicating the poorest recovery quality) to 150 (indicating the best recovery quality).

  postoperative day 1

Secondary Outcomes (4)

• the Quality of Recovery-15 on postoperative day 2

  postoperative day 2

• The weighted area under the curve (AUC) VAS pain score in the 7 days after surgery

  POD1, POD2, POD3, and POD7

• postoperative complications

  POD1, POD7, 1 month postoperatively, 2 months postoperatively, 3 months postoperatively, 6 months postoperatively

• Total hospitalization costs

  At the time of discharge (assessed up to 5 days)

Other Outcomes (3)

• The Quality of Recovery-15 score on the day before surgery

  the day before surgery

• Dosage of analgesics three days after surgery and fourteen days after surgery

  within 3 days postoperatively，within 7 days postoperatively

• Pain leading to unscheduled hospital returns or stay

  up to 1 month postoperatively

Study Arms (2)

the MB Group

a subcutaneous injection of 0.1% MB (1% MB 2 ml + 1% ropivacaine 5 ml + 0.9% saline 13 ml) will be administered with a skin test needle at the edge of the perianal incision

the ketorolac group

Patients in the ketorolac group will receive 30 mg of intravenous ketorolac ( Shandong New Times Pharmaceutical Co., Ltd, 1ml:30mg) at the beginning of the procedure.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This research is a multi-center prospective cohort study conducted at Qilu Hospital of Shandong University, Weifang People's Hospital, and Heze hospital of traditional chinese medicine. All of the patients in the study were of Chinese origin.

You may qualify if:

• Diagnosed with mixed hemorrhoids, grade III/ IV hemorrhoids (Goligher's classification), and underwent hemorrhoidectomy under spinal anesthesia; and
• Aged between 18 and 65 years; and
• ASA I or II.

You may not qualify if:

• Patients who experienced any ill-effects from previous use of MB or other medications in the protocol (ketorolac, ropivacaine); or
• Patients with diabetes; or
• Alcohol or other addictive drug dependence; or
• Illiteracy, combined with mental system or severe mental illness that prevented completion of the assessment; or
• Patients who are pregnant or breast-feeding; or
• Aspirin and analgesic drugs taken within 2 weeks before surgery; or
• Patients taking selective serotonin reuptake inhibitors (SSRIs); or
• Concurrent additional anorectal diseases (e.g., perianal abscess, anal fistula, fissures, anal incontinence); or
• Patients who are participating in other clinical trials and have not reached the endpoint.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead
• Weifang People's Hospital: collaborator
• Heze Hospital of Traditional Chinese Medicine: collaborator

Study Sites (3)

Heze Hospital of Traditional Chinese Medicine

Heze, Shandong, 274000, China

RECRUITING

Qilu hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Weifang People's Hospital

Weifang, Shandong, 261000, China

RECRUITING

Related Publications (3)

• Kleif J, Waage J, Christensen KB, Gogenur I. Systematic review of the QoR-15 score, a patient- reported outcome measure measuring quality of recovery after surgery and anaesthesia. Br J Anaesth. 2018 Jan;120(1):28-36. doi: 10.1016/j.bja.2017.11.013. Epub 2017 Nov 22.

  PMID: 29397134 BACKGROUND

• Yoon S, Joo H, Oh YM, Lee J, Bahk JH, Lee HJ. Validation and clinical utility of the Korean version of the Quality of Recovery-15 with enhanced recovery after surgery: a prospective observational cohort study. Br J Anaesth. 2020 Oct;125(4):614-621. doi: 10.1016/j.bja.2020.06.040. Epub 2020 Jul 21.

  PMID: 32703550 BACKGROUND

• Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.

  PMID: 10740540 BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Liang Li, MD

CONTACT

+8618560083822; liliang675@126.com

Teng Li, MD

CONTACT

+8618353086656; litengttkx@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 24, 2024
• Study Start: January 1, 2025
• Primary Completion: May 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 17, 2025

Record last verified: 2024-12

Locations

CN (3)