Ignite Creation Date:
2024-10-25 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06566521
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-18
Brief Title:
Thoracic Paravertebral Block in Daytime Laparoscopic Partial Adrenalectomy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Thoracic Paravertebral Block on Analgesia and the Quality of Recovery Following Daytime Laparoscopic Partial Adrenalectomy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 importantThoracic 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
The day surgery has put forward higher requirements for the management of perioperative anesthesia in which the postoperative multimodal analgesia is particularly importantThoracic 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
Detailed Description:
1 Study purpose
To investigate the impact of thoracic paravertebral block for postoperative analgesia and quality of recovery following daytime laparoscopic partial adrenalectomy
2 Study design
21 Type of the study
The research is a single-center double-blind randomized-controlled clinical trial
22 Sample size calculation
The estimated sample size was calculated using SPSS Statistics version 260 IBM Corp and this was based on our preliminary study in which the scores of the QoR-15 scale points mean standard deviation of the control group and the TPVB group at 24 hours postoperatively were 116267 and 124388 respectively The test level α was set to 005 the test power 1-β was set to 090 The sample size was determined to be 28 patients in each group Considering a dropout rate of approximately 20 35 individuals were included in each arm of this trial
23 Randomization and blinding
Patients were randomly assigned in a 11 ratio into 2 groups the control group or the TPVB group via centrally computer-generated group randomization Immediately after the surgery a sealed opaque envelope containing the patient group assignment was opened by an experienced anesthesiologist in charge TPVB was performed by the same anesthesiologist for the patients in the TPVB group while the patien in the control group did not receive nerve blockade
Participants in the control and TPVB groups were kept blinded to their group assignment This study involved researchers who conducted the postoperative follow-up and evaluation blinded and researchers who administered the treatment unblinded The unblinded researchers who administered the interventions were not involved in the evaluation of the postoperative outcomes
24 Intervention protocol
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 05 ropivacaine hydrochloride was injected Under ultrasound guidance the spread of the medication and downdraft of the pleura could be observed The patients in the control group did not undergo the nerve block procedure
3 Adverse events
Including postoperative nausea and vomiting as well as postoperative agitation and nerve block- related complications such as bleeding hematoma pneumothorax or nerve injury
4 Quality control
All research data both in paper and electronic formats will be kept for at least 5 years If readers have any questions after the article39s publication they may contact the corresponding author for access to the original data Patient information will remain anonymous including name ID number and telephone number All data related to enrolled patients collected during the study period of this project will be archived and safeguarded and all study members and study sponsors are asked to keep subject information confidential The study protocol will be reviewed and revised by statistical experts Investigators will adhere to pre-defined standard operating procedures encompassing patient screening follow-up standardization result assessment and data management The Ethics Committee of Shanxi Bethune Hospital will review the trial every six months
5 Statistical analysis
Statistical analysis was performed using SPSS Statistics version 260 Normally distributed continuous variables were presented as mean SD values and intergroup comparisons used independent-sample t-test Nonnormally distributed variables were presented as median IQR values and intergroup comparisons were determined using the Mann-Whitney test Categorical variables were expressed as frequencies and percentages and these were compared using either the χ2 test or the Fisher exact test A Plt005 was considered to be statistically significant
To investigate the impact of thoracic paravertebral block for postoperative analgesia and quality of recovery following daytime laparoscopic partial adrenalectomy
2 Study design
21 Type of the study
The research is a single-center double-blind randomized-controlled clinical trial
22 Sample size calculation
The estimated sample size was calculated using SPSS Statistics version 260 IBM Corp and this was based on our preliminary study in which the scores of the QoR-15 scale points mean standard deviation of the control group and the TPVB group at 24 hours postoperatively were 116267 and 124388 respectively The test level α was set to 005 the test power 1-β was set to 090 The sample size was determined to be 28 patients in each group Considering a dropout rate of approximately 20 35 individuals were included in each arm of this trial
23 Randomization and blinding
Patients were randomly assigned in a 11 ratio into 2 groups the control group or the TPVB group via centrally computer-generated group randomization Immediately after the surgery a sealed opaque envelope containing the patient group assignment was opened by an experienced anesthesiologist in charge TPVB was performed by the same anesthesiologist for the patients in the TPVB group while the patien in the control group did not receive nerve blockade
Participants in the control and TPVB groups were kept blinded to their group assignment This study involved researchers who conducted the postoperative follow-up and evaluation blinded and researchers who administered the treatment unblinded The unblinded researchers who administered the interventions were not involved in the evaluation of the postoperative outcomes
24 Intervention protocol
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 05 ropivacaine hydrochloride was injected Under ultrasound guidance the spread of the medication and downdraft of the pleura could be observed The patients in the control group did not undergo the nerve block procedure
3 Adverse events
Including postoperative nausea and vomiting as well as postoperative agitation and nerve block- related complications such as bleeding hematoma pneumothorax or nerve injury
4 Quality control
All research data both in paper and electronic formats will be kept for at least 5 years If readers have any questions after the article39s publication they may contact the corresponding author for access to the original data Patient information will remain anonymous including name ID number and telephone number All data related to enrolled patients collected during the study period of this project will be archived and safeguarded and all study members and study sponsors are asked to keep subject information confidential The study protocol will be reviewed and revised by statistical experts Investigators will adhere to pre-defined standard operating procedures encompassing patient screening follow-up standardization result assessment and data management The Ethics Committee of Shanxi Bethune Hospital will review the trial every six months
5 Statistical analysis
Statistical analysis was performed using SPSS Statistics version 260 Normally distributed continuous variables were presented as mean SD values and intergroup comparisons used independent-sample t-test Nonnormally distributed variables were presented as median IQR values and intergroup comparisons were determined using the Mann-Whitney test Categorical variables were expressed as frequencies and percentages and these were compared using either the χ2 test or the Fisher exact test A Plt005 was considered to be statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None