Trial Outcomes & Findings for Continuous Nerve Block Block vs Combination of Single Block Plus Intravenous Lidocaine for Postoperative Pain. (NCT NCT04208516)

Results Overview

Opioids will be converted to oral morphine equivalents

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

17 participants

Primary outcome timeframe

24 hours after surgery

Results posted on

2023-09-13

Participant Flow

For 3 patients under the abdominal portion of this study, Erector Spinae Blocks were performed rather than Quadratus Lumborum Blocks. There are various anatomic reasons why a different block would be considered when performing the actual block. This study was analyzing Quadratus Lumborum Blocks for abdominal surgery, as such, the results from the patients who had Erector Spinae Blocks for abdominal surgery were excluded.

Participant milestones

Participant milestones
Measure	Continuous Nerve Blocks A total of 7 subjects equally distributed to either continuous Erector Spinae Plane block for unilateral thoracic surgery, or continuous Quadratus Lumborum block for major abdominal surgery. Patients in this group will receive 20ml 0.5% ropivacaine per block performed after positioning of the needle followed by continuous perineural infusion of 0.25% lidocaine (10ml/hr) beginning in the post-anesthesia care unit (PACU) and continued for 72 hours or until 12 hours prior to patient discharge, whichever comes first, which is standard of care at this institution. Continuous Erector Spinae Plane Nerve Block: To be administered to subjects in the active comparator group receiving primary unilateral thoracic surgery. Continuous Quadratus Lumborum Nerve Block: To be administered to subjects in the active comparator group receiving primary major abdominal surgery. Ropivacaine 0.5% Injectable Solution: To be used in both treatment arms as nerve block initial bolus injection. Lidocaine: To be used perineurally as a 0.25% solution in the active comparator group at a rate of 10 ml/hr per perineural catheter.	Single Nerve Blocks Plus IV Lidocaine Infusion A total of 7 subjects equally distributed to either Erector Spinae Plane block for unilateral thoracic surgery, or Quadratus Lumborum block for major abdominal surgery, will be included . Patients in this group will receive 20ml 0.5% ropivacaine, 4mg dexamethasone, and 20mcg dexmedetomidine (30mcg if only one block is performed) per block after proper positioning of the Tuohy needle. Upon patient arrival in the recovery room a continuous infusion of IV lidocaine 50 mg /hr will be started and continued for 72 hours or until 12 hours prior to patient discharge, whichever comes first, which is standard of care at this institution. Single Erector Spinae Plane Nerve Block: To be administered to subjects in the experimental group receiving primary unilateral thoracic surgery. Single Quadratus Lumborum Nerve Block: To be administered to subjects in the experimental group receiving primary major abdominal surgery. Lidocaine IV: To be given postoperatively as a continuous infusion at a dose of 50 mg/hr in the experimental group. Ropivacaine 0.5% Injectable Solution: To be used in both treatment arms as nerve block initial bolus injection. Dexamethasone: To be used in the experimental arm as a nerve block adjuvant to promote prolonged single block duration, as is standard of care in this institution. Dexmedetomidine: To be used in the experimental arm as a nerve block adjuvant to promote prolonged single block duration, as is standard of care in this institution.
Overall Study STARTED	7	7
Overall Study COMPLETED	7	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Continuous Nerve Blocks n=7 Participants A total of 7 subjects equally distributed to either continuous Erector Spinae Plane block for unilateral thoracic surgery, or continuous Quadratus Lumborum block for major abdominal surgery. Patients in this group will receive 20ml 0.5% ropivacaine per block performed after positioning of the needle followed by continuous perineural infusion of 0.25% lidocaine (10ml/hr) beginning in the post-anesthesia care unit (PACU) and continued for 72 hours or until 12 hours prior to patient discharge, whichever comes first, which is standard of care at this institution. Continuous Erector Spinae Plane Nerve Block: To be administered to subjects in the active comparator group receiving primary unilateral thoracic surgery. Continuous Quadratus Lumborum Nerve Block: To be administered to subjects in the active comparator group receiving primary major abdominal surgery. Ropivacaine 0.5% Injectable Solution: To be used in both treatment arms as nerve block initial bolus injection. Lidocaine: To be used perineurally as a 0.25% solution in the active comparator group at a rate of 10 ml/hr per perineural catheter.	Single Nerve Blocks Plus IV Lidocaine Infusion n=7 Participants A total of 7 subjects equally distributed to either Erector Spinae Plane block for unilateral thoracic surgery, or Quadratus Lumborum block for major abdominal surgery, will be included . Patients in this group will receive 20ml 0.5% ropivacaine, 4mg dexamethasone, and 20mcg dexmedetomidine (30mcg if only one block is performed) per block after proper positioning of the Tuohy needle. Upon patient arrival in the recovery room a continuous infusion of IV lidocaine 50 mg /hr will be started and continued for 72 hours or until 12 hours prior to patient discharge, whichever comes first, which is standard of care at this institution. Single Erector Spinae Plane Nerve Block: To be administered to subjects in the experimental group receiving primary unilateral thoracic surgery. Single Quadratus Lumborum Nerve Block: To be administered to subjects in the experimental group receiving primary major abdominal surgery. Lidocaine IV: To be given postoperatively as a continuous infusion at a dose of 50 mg/hr in the experimental group. Ropivacaine 0.5% Injectable Solution: To be used in both treatment arms as nerve block initial bolus injection. Dexamethasone: To be used in the experimental arm as a nerve block adjuvant to promote prolonged single block duration, as is standard of care in this institution. Dexmedetomidine: To be used in the experimental arm as a nerve block adjuvant to promote prolonged single block duration, as is standard of care in this institution.	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=7 Participants	0 Participants n=7 Participants	0 Participants n=14 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=7 Participants	3 Participants n=7 Participants	4 Participants n=14 Participants
Age, Categorical >=65 years	6 Participants n=7 Participants	4 Participants n=7 Participants	10 Participants n=14 Participants
Age, Continuous	71.86 years STANDARD_DEVIATION 5.96 • n=7 Participants	65.43 years STANDARD_DEVIATION 7.72 • n=7 Participants	68.64 years STANDARD_DEVIATION 7.42 • n=14 Participants
Sex: Female, Male Female	2 Participants n=7 Participants	2 Participants n=7 Participants	4 Participants n=14 Participants
Sex: Female, Male Male	5 Participants n=7 Participants	5 Participants n=7 Participants	10 Participants n=14 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	7 participants n=7 Participants	7 participants n=7 Participants	7 participants n=14 Participants
Weight (kg)	78.29 kilograms STANDARD_DEVIATION 8.85 • n=7 Participants	84.71 kilograms STANDARD_DEVIATION 14.90 • n=7 Participants	81.50 kilograms STANDARD_DEVIATION 12.23 • n=14 Participants

PRIMARY outcome

Timeframe: 24 hours after surgery

Opioids will be converted to oral morphine equivalents

Outcome measures

Outcome measures
Measure	Continuous Nerve Blocks n=7 Participants A total of 7 subjects equally distributed to either continuous Erector Spinae Plane block for unilateral thoracic surgery, or continuous Quadratus Lumborum block for major abdominal surgery. Patients in this group will receive 20ml 0.5% ropivacaine per block performed after positioning of the needle followed by continuous perineural infusion of 0.25% lidocaine (10ml/hr) beginning in the post-anesthesia care unit (PACU) and continued for 72 hours or until 12 hours prior to patient discharge, whichever comes first, which is standard of care at this institution. Continuous Erector Spinae Plane Nerve Block: To be administered to subjects in the active comparator group receiving primary unilateral thoracic surgery. Continuous Quadratus Lumborum Nerve Block: To be administered to subjects in the active comparator group receiving primary major abdominal surgery. Ropivacaine 0.5% Injectable Solution: To be used in both treatment arms as nerve block initial bolus injection. Lidocaine: To be used perineurally as a 0.25% solution in the active comparator group at a rate of 10 ml/hr per perineural catheter.	Single Nerve Blocks Plus IV Lidocaine Infusion n=7 Participants A total of 7 subjects equally distributed to either Erector Spinae Plane block for unilateral thoracic surgery, or Quadratus Lumborum block for major abdominal surgery, will be included . Patients in this group will receive 20ml 0.5% ropivacaine, 4mg dexamethasone, and 20mcg dexmedetomidine (30mcg if only one block is performed) per block after proper positioning of the Tuohy needle. Upon patient arrival in the recovery room a continuous infusion of IV lidocaine 50 mg /hr will be started and continued for 72 hours or until 12 hours prior to patient discharge, whichever comes first, which is standard of care at this institution. Single Erector Spinae Plane Nerve Block: To be administered to subjects in the experimental group receiving primary unilateral thoracic surgery. Single Quadratus Lumborum Nerve Block: To be administered to subjects in the experimental group receiving primary major abdominal surgery. Lidocaine IV: To be given postoperatively as a continuous infusion at a dose of 50 mg/hr in the experimental group. Ropivacaine 0.5% Injectable Solution: To be used in both treatment arms as nerve block initial bolus injection. Dexamethasone: To be used in the experimental arm as a nerve block adjuvant to promote prolonged single block duration, as is standard of care in this institution. Dexmedetomidine: To be used in the experimental arm as a nerve block adjuvant to promote prolonged single block duration, as is standard of care in this institution.
Opioid Consumption After Surgery	34.93 OME Standard Deviation 31.32	46.50 OME Standard Deviation 33.37

SECONDARY outcome

Timeframe: 48 hours after surgery

Population: One patient from the single nerve block plus IV lidocaine infusion group was not included because they were discharged before 48 hours and opioids were not recorded as an outpatient.

Opioids will be converted to oral morphine equivalents

Outcome measures

Outcome measures
Measure	Continuous Nerve Blocks n=7 Participants A total of 7 subjects equally distributed to either continuous Erector Spinae Plane block for unilateral thoracic surgery, or continuous Quadratus Lumborum block for major abdominal surgery. Patients in this group will receive 20ml 0.5% ropivacaine per block performed after positioning of the needle followed by continuous perineural infusion of 0.25% lidocaine (10ml/hr) beginning in the post-anesthesia care unit (PACU) and continued for 72 hours or until 12 hours prior to patient discharge, whichever comes first, which is standard of care at this institution. Continuous Erector Spinae Plane Nerve Block: To be administered to subjects in the active comparator group receiving primary unilateral thoracic surgery. Continuous Quadratus Lumborum Nerve Block: To be administered to subjects in the active comparator group receiving primary major abdominal surgery. Ropivacaine 0.5% Injectable Solution: To be used in both treatment arms as nerve block initial bolus injection. Lidocaine: To be used perineurally as a 0.25% solution in the active comparator group at a rate of 10 ml/hr per perineural catheter.	Single Nerve Blocks Plus IV Lidocaine Infusion n=6 Participants A total of 7 subjects equally distributed to either Erector Spinae Plane block for unilateral thoracic surgery, or Quadratus Lumborum block for major abdominal surgery, will be included . Patients in this group will receive 20ml 0.5% ropivacaine, 4mg dexamethasone, and 20mcg dexmedetomidine (30mcg if only one block is performed) per block after proper positioning of the Tuohy needle. Upon patient arrival in the recovery room a continuous infusion of IV lidocaine 50 mg /hr will be started and continued for 72 hours or until 12 hours prior to patient discharge, whichever comes first, which is standard of care at this institution. Single Erector Spinae Plane Nerve Block: To be administered to subjects in the experimental group receiving primary unilateral thoracic surgery. Single Quadratus Lumborum Nerve Block: To be administered to subjects in the experimental group receiving primary major abdominal surgery. Lidocaine IV: To be given postoperatively as a continuous infusion at a dose of 50 mg/hr in the experimental group. Ropivacaine 0.5% Injectable Solution: To be used in both treatment arms as nerve block initial bolus injection. Dexamethasone: To be used in the experimental arm as a nerve block adjuvant to promote prolonged single block duration, as is standard of care in this institution. Dexmedetomidine: To be used in the experimental arm as a nerve block adjuvant to promote prolonged single block duration, as is standard of care in this institution.
Opioid Consumption After Surgery	61.5 OME Standard Deviation 54.06	84.75 OME Standard Deviation 65.57

SECONDARY outcome

Timeframe: 72 hours after surgery

Population: Two patients from the single nerve block plus IV lidocaine infusion group was not included because they were discharged before 72 hours and opioids were not recorded as an outpatient.

Opioids will be converted to oral morphine equivalents

Outcome measures

Outcome measures
Measure	Continuous Nerve Blocks n=7 Participants A total of 7 subjects equally distributed to either continuous Erector Spinae Plane block for unilateral thoracic surgery, or continuous Quadratus Lumborum block for major abdominal surgery. Patients in this group will receive 20ml 0.5% ropivacaine per block performed after positioning of the needle followed by continuous perineural infusion of 0.25% lidocaine (10ml/hr) beginning in the post-anesthesia care unit (PACU) and continued for 72 hours or until 12 hours prior to patient discharge, whichever comes first, which is standard of care at this institution. Continuous Erector Spinae Plane Nerve Block: To be administered to subjects in the active comparator group receiving primary unilateral thoracic surgery. Continuous Quadratus Lumborum Nerve Block: To be administered to subjects in the active comparator group receiving primary major abdominal surgery. Ropivacaine 0.5% Injectable Solution: To be used in both treatment arms as nerve block initial bolus injection. Lidocaine: To be used perineurally as a 0.25% solution in the active comparator group at a rate of 10 ml/hr per perineural catheter.	Single Nerve Blocks Plus IV Lidocaine Infusion n=5 Participants A total of 7 subjects equally distributed to either Erector Spinae Plane block for unilateral thoracic surgery, or Quadratus Lumborum block for major abdominal surgery, will be included . Patients in this group will receive 20ml 0.5% ropivacaine, 4mg dexamethasone, and 20mcg dexmedetomidine (30mcg if only one block is performed) per block after proper positioning of the Tuohy needle. Upon patient arrival in the recovery room a continuous infusion of IV lidocaine 50 mg /hr will be started and continued for 72 hours or until 12 hours prior to patient discharge, whichever comes first, which is standard of care at this institution. Single Erector Spinae Plane Nerve Block: To be administered to subjects in the experimental group receiving primary unilateral thoracic surgery. Single Quadratus Lumborum Nerve Block: To be administered to subjects in the experimental group receiving primary major abdominal surgery. Lidocaine IV: To be given postoperatively as a continuous infusion at a dose of 50 mg/hr in the experimental group. Ropivacaine 0.5% Injectable Solution: To be used in both treatment arms as nerve block initial bolus injection. Dexamethasone: To be used in the experimental arm as a nerve block adjuvant to promote prolonged single block duration, as is standard of care in this institution. Dexmedetomidine: To be used in the experimental arm as a nerve block adjuvant to promote prolonged single block duration, as is standard of care in this institution.
Opioid Consumption After Surgery	88.57 OME Standard Deviation 60.24	128.1 OME Standard Deviation 150.29

SECONDARY outcome

Timeframe: 6 hours after surgery

Population: One patient in the continuous nerve block group did not have pain scores recorded due to lethargy. They were not included in the analysis.