Systematic review of the QoR-15 score, a patient- reported outcome measure measuring quality of recovery after surgery and anaesthesia.
J Kleif, J Waage, K B Christensen...
https://pubmed.ncbi.nlm.nih.gov/29397134Actively Recruiting
Age: 18Years - 65Years
All Genders
ID06747195
The Impact of Intradermal Methylene Blue Injection on the Quality of Recovery in Patients Undergoing Hemorrhoidectomy: a Multicenter Prospective Cohort Study
Led by Qilu Hospital of Shandong University · Updated on 2025-02-17
290
Participants Needed
3
Research Sites
30 weeks
Total Duration
On this page
Sponsors
Q
Qilu Hospital of Shandong University
Lead Sponsor
W
Weifang People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effect of intradermal methylene blue combined with ropivacaine injection on the quality of recovery after hemorrhoidectomy, a surgical procedure for patients with symptomatic third- and fourth-degree hemorrhoids. This study focuses on how methylene blue, known for its pain-relief properties through temporary nerve disruption, affects recovery quality compared to intravenous ketorolac, a commonly used pain medication. The investigation uses the Quality of Recovery-15 (QOR-15) questionnaire to objectively measure recovery across physical and emotional dimensions. Participants will receive standardized spinal anesthesia with ropivacaine, followed by hemorrhoidectomy performed by experienced colorectal surgeons. Postoperative pain management varies by group: the methylene blue group receives a subcutaneous injection of methylene blue combined with ropivacaine around the perianal incision, while the comparison group receives intravenous ketorolac at the start of surgery. Additional ketorolac doses may be given after surgery if needed, with dosing limits in place. The study includes a 6-month follow-up to monitor complications and recovery. Participants will complete the QOR-15 questionnaire the day before surgery and on postoperative days 1 and 2, with the day 1 score as the primary outcome. Other measures include pain scores at several postoperative time points, total hospital costs, analgesic use, and complications such as urinary retention, fecal incontinence, itching, bleeding, infection, and wound healing problems. Data collection involves clinical information, telephone interviews, and the Wexner score for fecal incontinence, providing a thorough evaluation of recovery and safety over six months.
CONDITIONS
Brief Title
The Impact of Methylene Blue on the Quality of Recovery in Patients Undergoing Hemorrhoidectomy
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosed with mixed hemorrhoids, grade III or IV hemorrhoids (Goligher's classification), and undergoing hemorrhoidectomy under spinal anesthesia
- Aged between 18 and 65 years
- American Society of Anesthesiologists (ASA) physical status I or II
You will not qualify if you...
- History of adverse reactions to methylene blue, ketorolac, or ropivacaine
- Diagnosis of diabetes
- Dependence on alcohol or other addictive drugs
- Illiteracy or severe mental illness preventing completion of assessments
- Pregnancy or breastfeeding
- Use of aspirin or analgesic drugs within 2 weeks before surgery
- Use of selective serotonin reuptake inhibitors (SSRIs)
- Presence of additional anorectal diseases such as perianal abscess, anal fistula, fissures, or anal incontinence
- Participation in other clinical trials without reaching their endpoint
AI-Screening
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Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Surgery day and up to 14 days postoperative
Participants undergo hemorrhoidectomy surgery under spinal anesthesia and receive either an intradermal methylene blue combined with ropivacaine injection or intravenous ketorolac for postoperative pain relief.
1 surgery day visit and multiple assessments during the first 14 days postoperative
Follow-up
Duration - Up to 6 months postoperative
Participants are followed up for postoperative recovery and monitoring of complications such as pain, wound healing, and functional outcomes through phone interviews and evaluations.
Scheduled assessments at postoperative days 1, 2, 3, 7, 14 and at 1, 2, 3, and 6 months post-surgery
Trial Site Locations
Total: 3 locations
1
Heze Hospital of Traditional Chinese Medicine
Heze, Shandong, China, 274000
Actively Recruiting
2
Qilu hospital of Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
3
Weifang People's Hospital
Weifang, Shandong, China, 261000
Actively Recruiting
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Research Team
L
Liang Li, MD
T
Teng Li, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Validation and clinical utility of the Korean version of the Quality of Recovery-15 with enhanced recovery after surgery: a prospective observational cohort study.
Susie Yoon, Hyundeok Joo, Yoo Min Oh...
https://pubmed.ncbi.nlm.nih.gov/32703550Validity and reliability of a postoperative quality of recovery score: the QoR-40.
P S Myles, B Weitkamp, K Jones...
https://pubmed.ncbi.nlm.nih.gov/10740540