Thoracic Paravertebral Block in Daytime Laparoscopic Partial Adrenalectomy
NCT Number: NCT06566521
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Laparoscopic Adrenalectomy|Day Surgery
Interventions: PROCEDURE: thoracic paravertebral block
Sponsor: Shanxi Bethune Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-30
Completion Date: 2024-11-15

Summary:
Day surgery refers to the entire diagnostic and therapeutic process completed within 24-48 h, including patient admission, surgery, and discharge. Research by Shariq et al suggested that daytime laparoscopic adrenalectomy was a safe and effective alternative to traditional inpatient treatment. Li et al demonstrated that daytime surgery for laparoscopic partial adrenalectomy could reduce hospital stays, lower medical costs, and optimize healthcare resource utilization.

The day surgery has put forward higher requirements for the management of perioperative anesthesia, in which the postoperative multimodal analgesia is particularly important.Thoracic paravertebral block (TPVB) is a regional block technique in which local anaesthetics can be injected into paravertebral space to block the ipsilateral sympathetic and somatosensory nerves. TPVB single point injection can achieve sensory block of 3-6 spinal ganglia on one side, with minimal impact on respiratory, gastrointestinal and bladder function. Especially, TPVB does not affect motor nerve, which enable patients to perform painless functional exercise shortly after surgery, promote rapid recovery, and enhance satisfaction and comfort.

A large number of previous studies have shown that TPVB had become increasingly popular for postoperative analgesia after thoracic or breast surgery. However, to our knowledge, few studies to date have investigated the application of TPVB in daytime adrenal surgery. Therefore, we conducted this randomized clinical trial to examine the effect of TPVB on postoperative analgesia and the quality of recovery in patients following daytime laparoscopic partial adrenalectomy.

Primary Outcome Measures: Quality of Recovery, quality of recovery, measured using the 15-item Quality of Recovery questionnaire (QoR-15), It ranges from 0 to 150, with a higher score indicating a better quality of recovery, 24 and 48 hours postoperatively
Secondary Outcome Measures: pain scores at rest and during coughing, pain scores, measured using the Visual Analog Scale(0 points indicated no pain, a score \<4 indicated mild pain; a 4-7 score indicated moderate pain, a score \>7 points indicated severe pain, and a score of 10 indicated unbearably severe pain), 1, 6, 12, 24, and 48 hours after surgery|Opioid consumption, The total amount of sufentanil used in the PCA pump within the initial 48 h postoperatively, 48 hours postoperatively|Rate of remedial analgesia, The rate of remedial analgesia 48 hours postoperatively, 48 hours postoperatively|Postoperative gastrointestinal function outcomes, I-FEED scores(an I-FEED scores of 0-2 indicates postoperative gastrointestinal normality, 3-5 indicates postoperative gastrointestinal intolerance, and ≥6 indicates postoperative gastrointestinal dysfunction), 12, 24, and 48 hours after suegery|Times to first flatus and defecation, The time of first flatus and defecation within 48h after operation was measured by hour, 48 hours postoperatively