Health TrialsbyHealthPanel

Thoracic Paravertebral Block in Daytime Laparoscopic Partial Adrenalectomy

ConditionsLaparoscopic AdrenalectomyDay Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShanxi Bethune Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 to70 years

Body Mass Index (BMI) 18.5 to 30 kg/m²

American Society of Anesthesiologists (ASA) grade I to II classification

unilateral non-functional adrenal adenoma with a tumor diameter greater than 20mm

Disqualifiers

Patients with peripheral nervous system disease

Patients with spinal deformity or surgery

Patients with puncture site infection or coagulation abnormalities

Patients with history of postoperative nausea and vomiting or allergy to local anesthetics

Trial design

Design model

Parallel

Treatments tested in this trial

  • thoracic paravertebral block

    Procedure/Surgery

    After surgery and before extubation, the patient was positioned in an upper lateral position on the affected side. For patients in the TPVB group, an ultrasound high-frequency linear array probe was used to perform a mid-sagittal scan at the T8-9 spinous process interspace on the affected side. The probe was moved to visualize the T8-9 transverse process and pleura. Using the out-of-plane needling technique, the needle was inserted between the costotransverse ligament and the pleura in the paravertebral space adjacent to the thoracic vertebra. After confirmation of no blood or cerebrospinal fluid return, 30 mL of 0.5% ropivacaine hydrochloride was injected. Under ultrasound guidance, the spread of the medication and downdraft of the pleura could be observed.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: TPVB groupExperimental treatment 1 intervention
Group B: control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
24 and 48 hours postoperatively

Secondary outcomes

1

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)

Time frame
1, 6, 12, 24, and 48 hours after surgery
2

Opioid consumption

The total amount of sufentanil used in the PCA pump within the initial 48 h postoperatively

Time frame
48 hours postoperatively
3

Rate of remedial analgesia

The rate of remedial analgesia 48 hours postoperatively

Time frame
48 hours postoperatively
4

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)

Time frame
12, 24, and 48 hours after suegery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanxi Bethune Hospital

Lead sponsor

Source ClinicalTrials.gov
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