Benign Gallbladder Disease, Laparoscopic Cholecystectomy, Postoperative Pain, Quality of Recovery
Conditions
Keywords
Laparoscopic Cholecystectomy, Postoperative Pain, Quality of Recovery, Paravertebral Nerve Block, intercostal space block
Brief summary
After laparoscopic cholecystectomy, pain remains an important problem affecting patient recovery. A revised paravertebral block (r-PVB) was developed as a single-shot, large-volume intercostal-space injection performed at the exposed mid-axillary eighth or ninth intercostal level with the patient kept supine after induction of anesthesia. Rather than puncturing the classical paraspinal target near the transverse process with a specific prone or lateral position of the patient, r-PVB is designed to exploit medial spread of local anesthetic along the intercostal-endothoracic-extrapleural continuum, thereby generating a functional paravertebral block while avoiding direct entry into the paravertebral space and specific body positioning. r-PVB addresses several practical limitations of conventional PVB by eliminating the need to reposition an anesthetized patient, using a more accessible and potentially clearer sonographic window, reducing interference from transverse-process shadowing, and facilitating in-plane needle visualization.
Interventions
PROCEDURERevised-Paravertebral Nerve Block
Revised-Paravertebral Nerve Block (r-PVB) is performed after induction of general anesthesia and before the start of surgery. Under ultrasound guidance, an intercostal space between the 7th and 9th ribs at the midaxillary line is identified. Using an in-plane technique, the needle is advanced into the internal intercostal muscle, and 30 mL of 0.5% ropivacaine is injected to achieve the block.
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Scheduled for elective laparoscopic cholecystectomy for benign gallbladder disease
Exclusion criteria
* Contraindications to nerve block, including skin infection at the puncture site, increased intracranial pressure, uncorrectable coagulopathy, bridging indication for therapeutic anticoagulation (CHADS-VASc ≥ 8), sepsis, or allergy to local anesthetics * Surgeon-estimated high likelihood of conversion to open surgery * Chronic opioid use * Heart failure, liver failure, or renal failure * Coagulation disorders * History of allergy to local anesthetics * Inability to comply with the study protocol, including severe psychiatric illness, refusal to provide informed consent, or anticipated difficulty with postoperative follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean postoperative NRS pain score during the first 2 postoperative days | From discharge from the post-anesthesia care unit through postoperative day 2. | Postoperative pain will be assessed using theNumeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst pain the patient can imagine). The primary pain outcome is the mean of eight postoperative NRS pain scores assessed upon discharge from the post-anesthesia care unit; on the evening of surgery between 7:00 PM and 9:00 PM; and on postoperative days 1 and 2, in the morning between 6:00 AM and 10:00 AM, at midday between 12:00 PM and 3:00 PM, and in the evening between 7:00 PM and 9:00 PM. |
| Mean QoR-15 score on postoperative days 1 and 2 | Postoperative day 1 and postoperative day 2 | Quality of recovery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15), ranging from 0 (the worst) to 150 (the best). The primary recovery outcome is the mean QoR-15 score measured on postoperative day 1 and postoperative day 2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resting and movement NRS pain scores on postoperative days 1 and 2 | Postoperative day 1 and postoperative day 2 | Resting and movement-related pain will be assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst pain the patient can imagine), at predefined time points on postoperative days 1 and 2. |
| Proportion of participants with NRS pain score 4 or greater | Postoperative day 1 and postoperative day 2 | The proportion of participants with clinically significant pain, defined as an Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst pain the patient can imagine), score of 4 or greater, will be compared between groups. |
| Postoperative opioid and analgesic consumption | Postoperative day 1 and postoperative day 2 | Postoperative opioid and other analgesic consumption will be recorded and compared between groups. Opioid use will be converted to oral morphine equivalents where appropriate. |
| Postoperative complications | From surgery through postoperative day 30 | Postoperative complications, including pneumothorax, nausea, vomiting, dizziness, respiratory depression, and other adverse events, will be recorded and compared between groups. |
| Length of postoperative hospital stay | From surgery through postoperative day 30 | Length of hospital stay will be defined as the total number of days hospitalized after surgery, including readmission within 30 days if applicable. |
| Patient satisfaction with analgesia | Postoperative day 2 | Patient satisfaction with postoperative analgesia will be assessed using a Numeric Rating Scale, ranging from 0 (very dissatisfied) to 10 (very satisfied). |
Contacts
CONTACTXiangcai Ruan, MD
Outcome results
None listed