Trial Outcomes & Findings for Trial Comparing Impact of PENG Block on Quality of Recovery Compared to No-block for Primary Total Hip Arthroplasty (NCT NCT04591353)

Last Updated: 2024-02-15

Results Overview

The quality of recovery-15 is a validated questionnaire to assess postoperative recovery. I Scale is based on 15 questions, each question score range is 0-10 (0 being poor and 10 being excellent) The survey will be conducted at 24 hours after surgery Total score range is 0-150, where a score of 0 would be the worst possible score, and 150 would be the best possible score.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

122 participants

Primary outcome timeframe

24 hours after surgery

Results posted on

2024-02-15

Participant Flow

Participant milestones

Participant milestones
Measure	Investigational Group ("PENG Block" Group) Participants in the pericapsular nerve group block (PENG) arm will receive a PENG block preoperatively in the block area placed under direct ultrasound guidance as follows: Parenteral midazolam and fentanyl will be titrated to patient comfort. Standard skin sterilization, prepping and draping will be applied to the area Anatomical landmarks identified using ultrasound and skin will be numbed using 2-3 cc of 2% lidocaine. Long acting local anesthetic, a bolus of 25 cc of 0.5 % Bupivacaine will be injected lateral to iliopubic eminence (IPE). A Curvilinear low frequency (2-5 MHz) ultrasound probe will be used to identify landmarks. A 22 G, 10 cm needle will be inserted using in-plane technique and advanced to target site (17). PENG Block: The pericapsular nerve group (PENG) block is a novel regional anesthesia technique for providing analgesia after hip fractures and hip arthroplasties.	Control Group Control group participants will be transferred to the block area preoperatively, and care will proceed as if they were receiving injection. Patients will be placed in the supine position resting comfortably. Standard noninvasive monitors will be applied, and oxygen will be administered via nasal cannula. Parenteral midazolam and fentanyl will be titrated to patient comfort. Standard skin sterilization, prepping and draping will be applied to the area. The ultrasound probe will be used to identify the iliopubic eminence (IPE). Only skin will be numbed using 2-3 cc of 2% lidocaine and NO bolus of bupivacaine will be injected. Lidocaine: 2-3 cc of 2% lidocaine and NO bolus of bupivacaine will be injected.
Overall Study STARTED	61	61
Overall Study COMPLETED	56	56
Overall Study NOT COMPLETED	5	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trial Comparing Impact of PENG Block on Quality of Recovery Compared to No-block for Primary Total Hip Arthroplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Investigational Group ("PENG Block" Group) n=56 Participants Participants in the pericapsular nerve group block (PENG) arm will receive a PENG block preoperatively in the block area placed under direct ultrasound guidance as follows: Parenteral midazolam and fentanyl will be titrated to patient comfort. Standard skin sterilization, prepping and draping will be applied to the area Anatomical landmarks identified using ultrasound and skin will be numbed using 2-3 cc of 2% lidocaine. Long acting local anesthetic, a bolus of 25 cc of 0.5 % Bupivacaine will be injected lateral to iliopubic eminence (IPE). A Curvilinear low frequency (2-5 MHz) ultrasound probe will be used to identify landmarks. A 22 G, 10 cm needle will be inserted using in-plane technique and advanced to target site (17). PENG Block: The pericapsular nerve group (PENG) block is a novel regional anesthesia technique for providing analgesia after hip fractures and hip arthroplasties.	Control Group n=56 Participants Control group participants will be transferred to the block area preoperatively, and care will proceed as if they were receiving injection. Patients will be placed in the supine position resting comfortably. Standard noninvasive monitors will be applied, and oxygen will be administered via nasal cannula. Parenteral midazolam and fentanyl will be titrated to patient comfort. Standard skin sterilization, prepping and draping will be applied to the area. The ultrasound probe will be used to identify the iliopubic eminence (IPE). Only skin will be numbed using 2-3 cc of 2% lidocaine and NO bolus of bupivacaine will be injected. Lidocaine: 2-3 cc of 2% lidocaine and NO bolus of bupivacaine will be injected.	Total n=112 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	56 Participants n=5 Participants	56 Participants n=7 Participants	112 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	58.5 YEARS STANDARD_DEVIATION 14.9 • n=5 Participants	62.1 YEARS STANDARD_DEVIATION 10.7 • n=7 Participants	60.3 YEARS STANDARD_DEVIATION 12.8 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	34 Participants n=7 Participants	64 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	22 Participants n=7 Participants	48 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	20 Participants n=5 Participants	28 Participants n=7 Participants	48 Participants n=5 Participants
Race (NIH/OMB) White	36 Participants n=5 Participants	28 Participants n=7 Participants	64 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours after surgery

Outcome measures

Outcome measures
Measure	Control Group n=56 Participants Control group participants will be transferred to the block area preoperatively, and care will proceed as if they were receiving injection. Patients will be placed in the supine position resting comfortably. Standard noninvasive monitors will be applied, and oxygen will be administered via nasal cannula. Parenteral midazolam and fentanyl will be titrated to patient comfort. Standard skin sterilization, prepping and draping will be applied to the area. The ultrasound probe will be used to identify the iliopubic eminence (IPE). Only skin will be numbed using 2-3 cc of 2% lidocaine and NO bolus of bupivacaine will be injected. Lidocaine: 2-3 cc of 2% lidocaine and NO bolus of bupivacaine will be injected.	Investigational Group ("PENG Block" Group) n=56 Participants Participants in the pericapsular nerve group block (PENG) arm will receive a PENG block preoperatively in the block area placed under direct ultrasound guidance as follows: Parenteral midazolam and fentanyl will be titrated to patient comfort. Standard skin sterilization, prepping and draping will be applied to the area Anatomical landmarks identified using ultrasound and skin will be numbed using 2-3 cc of 2% lidocaine. Long acting local anesthetic, a bolus of 25 cc of 0.5 % Bupivacaine will be injected lateral to iliopubic eminence (IPE). A Curvilinear low frequency (2-5 MHz) ultrasound probe will be used to identify landmarks. A 22 G, 10 cm needle will be inserted using in-plane technique and advanced to target site (17). PENG Block: The pericapsular nerve group (PENG) block is a novel regional anesthesia technique for providing analgesia after hip fractures and hip arthroplasties.
Recovery After Total Hip Arthroplasty	103 score on a scale Interval 97.0 to 111.0	131.5 score on a scale Interval 116.0 to 138.0

SECONDARY outcome

Timeframe: 2 days after surgery

Quality of recovery (QoR) survey at 48 hours after surgery. QoR-15 scores range from 0 (extremely poor quality of recovery) to 150 (excellent quality of recovery).

Outcome measures

Outcome measures
Measure	Control Group n=56 Participants Control group participants will be transferred to the block area preoperatively, and care will proceed as if they were receiving injection. Patients will be placed in the supine position resting comfortably. Standard noninvasive monitors will be applied, and oxygen will be administered via nasal cannula. Parenteral midazolam and fentanyl will be titrated to patient comfort. Standard skin sterilization, prepping and draping will be applied to the area. The ultrasound probe will be used to identify the iliopubic eminence (IPE). Only skin will be numbed using 2-3 cc of 2% lidocaine and NO bolus of bupivacaine will be injected. Lidocaine: 2-3 cc of 2% lidocaine and NO bolus of bupivacaine will be injected.	Investigational Group ("PENG Block" Group) n=56 Participants Participants in the pericapsular nerve group block (PENG) arm will receive a PENG block preoperatively in the block area placed under direct ultrasound guidance as follows: Parenteral midazolam and fentanyl will be titrated to patient comfort. Standard skin sterilization, prepping and draping will be applied to the area Anatomical landmarks identified using ultrasound and skin will be numbed using 2-3 cc of 2% lidocaine. Long acting local anesthetic, a bolus of 25 cc of 0.5 % Bupivacaine will be injected lateral to iliopubic eminence (IPE). A Curvilinear low frequency (2-5 MHz) ultrasound probe will be used to identify landmarks. A 22 G, 10 cm needle will be inserted using in-plane technique and advanced to target site (17). PENG Block: The pericapsular nerve group (PENG) block is a novel regional anesthesia technique for providing analgesia after hip fractures and hip arthroplasties.
Evaluating Recovery After Total Hip Arthroplasty	108 score on a scale Interval 100.0 to 119.5	136 score on a scale Interval 22.5 to 143.0

SECONDARY outcome

Timeframe: 24 and 48 hours after surgery

Measuring the average milligrams of oral morphine equivalent (OME) consumption at 24 and 48 hours after surgery

Outcome measures

Outcome measures
Measure	Control Group n=56 Participants Control group participants will be transferred to the block area preoperatively, and care will proceed as if they were receiving injection. Patients will be placed in the supine position resting comfortably. Standard noninvasive monitors will be applied, and oxygen will be administered via nasal cannula. Parenteral midazolam and fentanyl will be titrated to patient comfort. Standard skin sterilization, prepping and draping will be applied to the area. The ultrasound probe will be used to identify the iliopubic eminence (IPE). Only skin will be numbed using 2-3 cc of 2% lidocaine and NO bolus of bupivacaine will be injected. Lidocaine: 2-3 cc of 2% lidocaine and NO bolus of bupivacaine will be injected.	Investigational Group ("PENG Block" Group) n=56 Participants Participants in the pericapsular nerve group block (PENG) arm will receive a PENG block preoperatively in the block area placed under direct ultrasound guidance as follows: Parenteral midazolam and fentanyl will be titrated to patient comfort. Standard skin sterilization, prepping and draping will be applied to the area Anatomical landmarks identified using ultrasound and skin will be numbed using 2-3 cc of 2% lidocaine. Long acting local anesthetic, a bolus of 25 cc of 0.5 % Bupivacaine will be injected lateral to iliopubic eminence (IPE). A Curvilinear low frequency (2-5 MHz) ultrasound probe will be used to identify landmarks. A 22 G, 10 cm needle will be inserted using in-plane technique and advanced to target site (17). PENG Block: The pericapsular nerve group (PENG) block is a novel regional anesthesia technique for providing analgesia after hip fractures and hip arthroplasties.
Average Pain Medicine Required After Surgery. 24 hour	59.5 Milligrams Standard Deviation 43.4	37.3 Milligrams Standard Deviation 29.7
Average Pain Medicine Required After Surgery. 48hour	75.4 Milligrams Standard Deviation 57.8	47.1 Milligrams Standard Deviation 40.5

SECONDARY outcome

Timeframe: Recovery (PACU), 6, 12, 24 and 48 hours after surgery

Pain scores (visual analog scores VAS) in recovery (PACU), 6, 12, 24 and 48 hours after surgery

Outcome measures

Outcome measures
Measure	Control Group n=56 Participants Control group participants will be transferred to the block area preoperatively, and care will proceed as if they were receiving injection. Patients will be placed in the supine position resting comfortably. Standard noninvasive monitors will be applied, and oxygen will be administered via nasal cannula. Parenteral midazolam and fentanyl will be titrated to patient comfort. Standard skin sterilization, prepping and draping will be applied to the area. The ultrasound probe will be used to identify the iliopubic eminence (IPE). Only skin will be numbed using 2-3 cc of 2% lidocaine and NO bolus of bupivacaine will be injected. Lidocaine: 2-3 cc of 2% lidocaine and NO bolus of bupivacaine will be injected.	Investigational Group ("PENG Block" Group) n=56 Participants Participants in the pericapsular nerve group block (PENG) arm will receive a PENG block preoperatively in the block area placed under direct ultrasound guidance as follows: Parenteral midazolam and fentanyl will be titrated to patient comfort. Standard skin sterilization, prepping and draping will be applied to the area Anatomical landmarks identified using ultrasound and skin will be numbed using 2-3 cc of 2% lidocaine. Long acting local anesthetic, a bolus of 25 cc of 0.5 % Bupivacaine will be injected lateral to iliopubic eminence (IPE). A Curvilinear low frequency (2-5 MHz) ultrasound probe will be used to identify landmarks. A 22 G, 10 cm needle will be inserted using in-plane technique and advanced to target site (17). PENG Block: The pericapsular nerve group (PENG) block is a novel regional anesthesia technique for providing analgesia after hip fractures and hip arthroplasties.
Pain Scores After Surgery PACU	2.3 score on a scale Standard Deviation 1.7	1.8 score on a scale Standard Deviation 1.5
Pain Scores After Surgery 6 Hour	2.5 score on a scale Standard Deviation 2.8	2.3 score on a scale Standard Deviation 2.7
Pain Scores After Surgery 12 Hour	2.0 score on a scale Standard Deviation 2.3	1.9 score on a scale Standard Deviation 2.3
Pain Scores After Surgery 24 Hour	2.8 score on a scale Standard Deviation 2.2	2.8 score on a scale Standard Deviation 2.3
Pain Scores After Surgery 48 Hour	2.7 score on a scale Standard Deviation 2.3	2.0 score on a scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: 24 and 48 hours after surgery

ambulation distance as recorded by physical therapist at 24 and 48 hours after surgery

Outcome measures

Outcome measures
Measure	Control Group n=56 Participants Control group participants will be transferred to the block area preoperatively, and care will proceed as if they were receiving injection. Patients will be placed in the supine position resting comfortably. Standard noninvasive monitors will be applied, and oxygen will be administered via nasal cannula. Parenteral midazolam and fentanyl will be titrated to patient comfort. Standard skin sterilization, prepping and draping will be applied to the area. The ultrasound probe will be used to identify the iliopubic eminence (IPE). Only skin will be numbed using 2-3 cc of 2% lidocaine and NO bolus of bupivacaine will be injected. Lidocaine: 2-3 cc of 2% lidocaine and NO bolus of bupivacaine will be injected.	Investigational Group ("PENG Block" Group) n=56 Participants Participants in the pericapsular nerve group block (PENG) arm will receive a PENG block preoperatively in the block area placed under direct ultrasound guidance as follows: Parenteral midazolam and fentanyl will be titrated to patient comfort. Standard skin sterilization, prepping and draping will be applied to the area Anatomical landmarks identified using ultrasound and skin will be numbed using 2-3 cc of 2% lidocaine. Long acting local anesthetic, a bolus of 25 cc of 0.5 % Bupivacaine will be injected lateral to iliopubic eminence (IPE). A Curvilinear low frequency (2-5 MHz) ultrasound probe will be used to identify landmarks. A 22 G, 10 cm needle will be inserted using in-plane technique and advanced to target site (17). PENG Block: The pericapsular nerve group (PENG) block is a novel regional anesthesia technique for providing analgesia after hip fractures and hip arthroplasties.
Ambulation Distance After Surgery 24 Hour	104.0 feet Standard Deviation 72.0	121.3 feet Standard Deviation 75.3
Ambulation Distance After Surgery 48 Hour	81.2 feet Standard Deviation 52.0	78.9 feet Standard Deviation 47.5

SECONDARY outcome

Timeframe: up to 2 days after surgery

use of any medication for nausea or vomiting prevention after surgery

Outcome measures

Outcome measures
Measure	Control Group n=56 Participants Control group participants will be transferred to the block area preoperatively, and care will proceed as if they were receiving injection. Patients will be placed in the supine position resting comfortably. Standard noninvasive monitors will be applied, and oxygen will be administered via nasal cannula. Parenteral midazolam and fentanyl will be titrated to patient comfort. Standard skin sterilization, prepping and draping will be applied to the area. The ultrasound probe will be used to identify the iliopubic eminence (IPE). Only skin will be numbed using 2-3 cc of 2% lidocaine and NO bolus of bupivacaine will be injected. Lidocaine: 2-3 cc of 2% lidocaine and NO bolus of bupivacaine will be injected.	Investigational Group ("PENG Block" Group) n=56 Participants Participants in the pericapsular nerve group block (PENG) arm will receive a PENG block preoperatively in the block area placed under direct ultrasound guidance as follows: Parenteral midazolam and fentanyl will be titrated to patient comfort. Standard skin sterilization, prepping and draping will be applied to the area Anatomical landmarks identified using ultrasound and skin will be numbed using 2-3 cc of 2% lidocaine. Long acting local anesthetic, a bolus of 25 cc of 0.5 % Bupivacaine will be injected lateral to iliopubic eminence (IPE). A Curvilinear low frequency (2-5 MHz) ultrasound probe will be used to identify landmarks. A 22 G, 10 cm needle will be inserted using in-plane technique and advanced to target site (17). PENG Block: The pericapsular nerve group (PENG) block is a novel regional anesthesia technique for providing analgesia after hip fractures and hip arthroplasties.
Total Patients Using Antiemetics After Surgery	19 Participants	17 Participants

Adverse Events

Investigational Group ("PENG Block" Group)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Promil Kukreja

University of Alabama at Birmingham

Phone: 205-934-4042

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place