Superior HypogastrIc plExus bLock During Laparoscopic Colorectal Cancer Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSixth Affiliated Hospital, Sun Yat-sen University
About this trial
This trial seeks to assess the efficacy of a superior hypogastric plexus block for early quality of recovery after laparoscopic colorectal cancer surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Able to provide informed consent.
Undergoing elective laparoscopic radical resection for colorectal cancer.
American Society of Anesthesiologists Physical Status (ASA) class I-III.
Disqualifiers
Allergy to block medication (s).
Coagulation dysfunction.
Local or systemic infection.
Unable to cooperate with the completion of the study protocol.
Trial design
Design model
Parallel
Treatments tested in this trial
Superior hypogastric plexus block
Procedure/SurgeryAfter 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.
Treatment groups
170 Participants
are divided into 2 treatment groupsGroup A: Nerve blockExperimental treatment 1 intervention
Group B: Placebo blockPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to postoperative day 2Secondary outcomes
1
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.
Time frame
Up to postoperative day 22
Postoperative Opioid Use
Postoperative opioid consumption during said time points
Time frame
Up to postoperative day 23
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.
Time frame
Up to postoperative day 904
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).
Time frame
Up to postoperative day 90Other outcomes
1
Incidence of Adverse events
Incidence of adverse events related to the plexus block (vascular puncture, hematoma, and local anesthetic systemic toxicity (LAST))
Time frame
Intraoperative (During block performance)Sponsors and contacts
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Source ClinicalTrials.gov