Thoracic Paravertebral Block in Daytime Laparoscopic Partial Adrenalectomy

NCT06566521 | Recruiting

• 1 other identifier: YXLL-2024-144
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Laparoscopic Adrenalectomy; Day Surgery

Keywords

laparoscopic partial adrenalectomy; thoracic paravertebral block; daytime mode; analgesia; recovery quality

Outcome Measures

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

  24 and 48 hours postoperatively

Secondary Outcomes (5)

• pain scores at rest and during coughing

  1, 6, 12, 24, and 48 hours after surgery

• Opioid consumption

  48 hours postoperatively

• Rate of remedial analgesia

  48 hours postoperatively

• Postoperative gastrointestinal function outcomes

  12, 24, and 48 hours after suegery

• Times to first flatus and defecation

  48 hours postoperatively

Study Arms (2)

TPVB group

EXPERIMENTAL

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.

Procedure: thoracic paravertebral block

control group

NO INTERVENTION

The patients in the control group did not undergo the nerve block procedure.

Interventions

thoracic paravertebral block PROCEDURE

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.

TPVB group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Patients with unstable mental illness or refusal to participate

Sponsors & Collaborators

• Shanxi Bethune Hospital: lead

Study Sites (1)

Shanxi Bethune Hospital

Taiyuan, Shanxi, 030032, China

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jian-Wen Zhang, MD

  Shanxi Bethune Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian-Wen Zhang, MD

CONTACT

+86 13994299284; zjw030001@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2024
• First Posted: August 22, 2024
• Study Start: August 23, 2024
• Primary Completion: October 31, 2024
• Study Completion: November 15, 2024
• Last Updated: October 31, 2024

Record last verified: 2024-08

Locations

CN (1)