Intrathecal Morphine and Ropivacaine for Quality of Recovery After Laparoscopic Colorectal Surgery: A Randomized Controlled Trial.
Ying Yang, Wenjun Lin, Yifen Zhuo...
https://pubmed.ncbi.nlm.nih.gov/39717198Actively Recruiting
Phase Not Applicable
Age: 18Years - 65Years
FEMALE
ID07232108
Effects of Intrathecal Morphine Compared With Trocar-Site Infiltration and Intraperitoneal Bupivacaine on Postoperative Quality of Recovery and Inflammatory Markers After Laparoscopic Hysterectomy
Led by Ataturk University · Updated on 2025-12-08
64
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare two methods of pain relief after elective laparoscopic hysterectomy, a common surgery for benign gynecological conditions. The study evaluates the effects of intrathecal morphine versus trocar-site infiltration and intraperitoneal bupivacaine on postoperative pain control, quality of recovery, and inflammatory response. Postoperative pain can arise from surgical trauma and peritoneal irritation, and effective pain management may improve comfort and recovery while reducing opioid use. Participants will be randomly assigned to one of two groups. The first group receives a single dose of 200 µg intrathecal morphine injected into the spinal area before general anesthesia. The second group receives local anesthetic treatment with 0.25% bupivacaine infiltrated at trocar sites and sprayed intraperitoneally at the end of surgery, with total doses kept within safety limits. Both groups receive standard general anesthesia and additional medications as part of multimodal pain management. Participants will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire before surgery and 24 hours after. Pain levels, opioid use, time to mobilization and bowel movement, and side effects like nausea, vomiting, and respiratory issues will be monitored closely. Blood samples will be taken before surgery and 24 hours after to measure inflammatory markers. The study is blinded so that patients and care teams do not know which treatment was given. The trial aims to help optimize pain relief strategies for better recovery after laparoscopic hysterectomy.
CONDITIONS
Brief Title
Intrathecal Morphine Versus Trocar-Site and Intraperitoneal Bupivacaine for Quality of Recovery After Laparoscopic Hysterectomy
Who Can Participate
Age: 18Years - 65Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 65 years
- Elective laparoscopic hysterectomy planned for benign gynecological conditions
- American Society of Anesthesiologists (ASA) physical status I to III
- Ability to provide written informed consent
You will not qualify if you...
- Coagulopathy or bleeding disorders
- Opioid dependence or chronic opioid use
- Allergy or contraindication to local anesthetics or morphine
- Contraindication to neuraxial (spinal) anesthesia
- History of chronic pain syndromes
- Severe renal or hepatic dysfunction
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
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) for eligibility assessment and consent
Treatment
Duration - Day of surgery
Participants undergo laparoscopic hysterectomy with either intrathecal morphine injection before general anesthesia induction or trocar-site and intraperitoneal bupivacaine infiltration at the end of surgery to manage postoperative pain.
1 surgical procedure day visit
Postoperative Follow-up
Duration - 24 hours postoperatively
Participants are monitored for quality of recovery, pain, side effects, and inflammatory markers for 24 hours after surgery.
Frequent assessments including pain scores every 2 hours from 2 to 24 hours postoperatively and 1 follow-up visit at 24 hours
Trial Site Locations
Total: 1 location
1
Ataturk University
Erzurum, Turkey (Türkiye), 25000
Actively Recruiting
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Research Team
A
Ayşenur Dostbil, Associate Professor
M
Mehmet Akif Yılmaz, assistant doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Hailin Xing, Donglan Yuan, Yabin Zhu...
https://pubmed.ncbi.nlm.nih.gov/39049119Can Neutrophil-Lymphocyte Ratio, Platelet-Lymphocyte Ratio, or Systemic Immune Inflammation Index Be an Indicator of Postoperative Pain in Patients Undergoing Laparoscopic Cholecystectomy?
Şenay Canikli Adıgüzel, Dilan Akyurt, Hatice Bahadır Altun...
https://pubmed.ncbi.nlm.nih.gov/36820108The validity and reliability of the Turkish version of the quality of recovery-15 (QoR-15) questionnaire.
Emine Aslanlar, Durmuş Ali Aslanlar, Cennet Doğanay...
https://pubmed.ncbi.nlm.nih.gov/38640327Measurement of quality of recovery after surgery using the 15-item quality of recovery scale: a systematic review and meta-analysis.
Paul S Myles, Mark A Shulman, Jennifer Reilly...
https://pubmed.ncbi.nlm.nih.gov/35430086Systematic 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...
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Peter A Stark, Paul S Myles, Justin A Burke
https://pubmed.ncbi.nlm.nih.gov/23411725Analgesia for major laparoscopic abdominal surgery: a randomised feasibility trial using intrathecal morphine.
K Pirie, M A Doane, B Riedel...
https://pubmed.ncbi.nlm.nih.gov/35038165Unilateral subcostal anterior quadratus lumborum block versus intrathecal morphine for postoperative pain in laparoscopic nephrectomy: a randomized controlled trial.
Cengiz Kaya, Burhan Dost, Esra Turunc...
https://pubmed.ncbi.nlm.nih.gov/40639953The effect of subcutaneous and intraperitoneal anesthesia on post laparoscopic pain: a randomized controlled trial.
Ohad Gluck, Elad Barber, Ohad Feldstein...
https://pubmed.ncbi.nlm.nih.gov/33420214