Trial Outcomes & Findings for Selective Intraoperative Administration of Local Anesthesia in Breast Reconstruction (NCT NCT02525718)

NCT ID: NCT02525718

Last Updated: 2019-08-14

Results Overview

The primary outcome measure is a well-validated and widely used survey measuring the quality of recovery from anesthesia entitled the "Global 40 Item Quality of Recovery" survey. This is a 40 question survey administered to patients to allow them to rate their quality of recovery along a number of different dimensions, including emotional state, physical comfort, psychological support, physical independence, and pain. The score ranges from 40 to 200, with 40 representing a very poor overall quality of recovery and 200 representing the best possible recovery. The following reference explains the Global 40 Item Quality of Recovery survey in detail: Myles, P.S., et al., Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth, 2000. 84(1): p. 11-5. PMID: 10740540

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 47 participants
• Primary outcome timeframe: 24 hours post-operatively
• Results posted on: 2019-08-14

Participant Flow

Participant milestones

Measure	Placebo Subjects will be randomly selected to receive saline (placebo), administered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery. Saline: If randomized to this arm, subjects will receive an intraoperative injection of saline. (2.5 mg/ml)	0.25 % Bupivacaine w/ Epinephrine & 4mg Dexamethasone Subjects will be randomly selected to receive selective block with a local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone. The injection will be performed in certain locations of the breast area to cover the intercostal nerves supplying the breast tissue. Subjects will be randomly selected to receive the local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasoneadministered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery. 0.25 % bupivacaine (2.5 mg/ml) w/ 1:100,000 epinephrine \& 4 mg dexamethasone: If randomized to this arm, subjects will receive a selective block with a local anesthetic solution containing 0.25 % bupivacaine. (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone intraoperatively.
Overall Study STARTED	23	24
Overall Study COMPLETED	22	23
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Selective Intraoperative Administration of Local Anesthesia in Breast Reconstruction

Baseline characteristics by cohort

Measure	Placebo n=22 Participants Subjects will be randomly selected to receive saline (placebo), administered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery. Saline: If randomized to this arm, subjects will receive an intraoperative injection of saline. (2.5 mg/ml)	0.25 % Bupivacaine w/ Epinephrine & 4mg Dexamethasone n=23 Participants Subjects will be randomly selected to receive selective block with a local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone. The injection will be performed in certain locations of the breast area to cover the intercostal nerves supplying the breast tissue. Subjects will be randomly selected to receive the local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasoneadministered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery. 0.25 % bupivacaine (2.5 mg/ml) w/ 1:100,000 epinephrine \& 4 mg dexamethasone: If randomized to this arm, subjects will receive a selective block with a local anesthetic solution containing 0.25 % bupivacaine. (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone intraoperatively.	Total n=45 Participants Total of all reporting groups
Age, Continuous	50 years n=5 Participants	48 years n=7 Participants	49 years n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	23 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants	23 participants n=7 Participants	45 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours post-operatively

The primary outcome measure is a well-validated and widely used survey measuring the quality of recovery from anesthesia entitled the "Global 40 Item Quality of Recovery" survey. This is a 40 question survey administered to patients to allow them to rate their quality of recovery along a number of different dimensions, including emotional state, physical comfort, psychological support, physical independence, and pain. The score ranges from 40 to 200, with 40 representing a very poor overall quality of recovery and 200 representing the best possible recovery. The following reference explains the Global 40 Item Quality of Recovery survey in detail:

Myles, P.S., et al., Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth, 2000. 84(1): p. 11-5.

PMID: 10740540

Outcome measures

Measure	Placebo n=22 Participants Subjects will be randomly selected to receive saline (placebo), administered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery. Saline: If randomized to this arm, subjects will receive an intraoperative injection of saline. (2.5 mg/ml)	0.25 % Bupivacaine w/ Epinephrine & 4mg Dexamethasone n=23 Participants Subjects will be randomly selected to receive selective block with a local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone. The injection will be performed in certain locations of the breast area to cover the intercostal nerves supplying the breast tissue. Subjects will be randomly selected to receive the local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasoneadministered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery. 0.25 % bupivacaine (2.5 mg/ml) w/ 1:100,000 epinephrine \& 4 mg dexamethasone: If randomized to this arm, subjects will receive a selective block with a local anesthetic solution containing 0.25 % bupivacaine. (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone intraoperatively.
Quality of Recovery Score	165 score on a scale Interval 143.0 to 179.0	169 score on a scale Interval 155.0 to 182.0

SECONDARY outcome

Timeframe: 24 hrs

A study-specific pain form was provided to the patient and nursing staff that consisted of standard visual analogue scale (VAS) for patients to rate their pain level. Pain level was rated as a categorical level from 0 to 10, in 1 unit increments, with 0 being "no pain at all" and 10 being "worst pain imaginable." Thus a total of 10 pain grades were possible.

Outcome measures

Measure	Placebo n=22 Participants Subjects will be randomly selected to receive saline (placebo), administered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery. Saline: If randomized to this arm, subjects will receive an intraoperative injection of saline. (2.5 mg/ml)	0.25 % Bupivacaine w/ Epinephrine & 4mg Dexamethasone n=23 Participants Subjects will be randomly selected to receive selective block with a local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone. The injection will be performed in certain locations of the breast area to cover the intercostal nerves supplying the breast tissue. Subjects will be randomly selected to receive the local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasoneadministered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery. 0.25 % bupivacaine (2.5 mg/ml) w/ 1:100,000 epinephrine \& 4 mg dexamethasone: If randomized to this arm, subjects will receive a selective block with a local anesthetic solution containing 0.25 % bupivacaine. (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone intraoperatively.
Pain Score Using 10-point Visual Analog Scale (VAS)	4 score on a scale Interval 2.0 to 6.0	4 score on a scale Interval 3.0 to 6.0

SECONDARY outcome

Timeframe: 24 hrs

Total opioid consumption in the first 24 hrs of recovery after surgery as measured in "morphine equivalents." This involves converting the dose of a non-morphine narcotic (e.g. IV hydromorphone or oral hydrocodone) into the equi-analgesic dose of morphine, so that the total amount of narcotic utilized by the patient can be compared. This is a standard technique for comparison utilized in the pain management literature.

Outcome measures

Measure	Placebo n=22 Participants Subjects will be randomly selected to receive saline (placebo), administered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery. Saline: If randomized to this arm, subjects will receive an intraoperative injection of saline. (2.5 mg/ml)	0.25 % Bupivacaine w/ Epinephrine & 4mg Dexamethasone n=23 Participants Subjects will be randomly selected to receive selective block with a local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone. The injection will be performed in certain locations of the breast area to cover the intercostal nerves supplying the breast tissue. Subjects will be randomly selected to receive the local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasoneadministered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery. 0.25 % bupivacaine (2.5 mg/ml) w/ 1:100,000 epinephrine \& 4 mg dexamethasone: If randomized to this arm, subjects will receive a selective block with a local anesthetic solution containing 0.25 % bupivacaine. (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone intraoperatively.
Opioid Consumption	114 Morphine equivalents Interval 69.0 to 161.0	92 Morphine equivalents Interval 44.0 to 142.0

SECONDARY outcome

Timeframe: 4 days

Number of postoperative days patients stay in the hospital after surgery

Outcome measures

Measure	Placebo n=22 Participants Subjects will be randomly selected to receive saline (placebo), administered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery. Saline: If randomized to this arm, subjects will receive an intraoperative injection of saline. (2.5 mg/ml)	0.25 % Bupivacaine w/ Epinephrine & 4mg Dexamethasone n=23 Participants Subjects will be randomly selected to receive selective block with a local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone. The injection will be performed in certain locations of the breast area to cover the intercostal nerves supplying the breast tissue. Subjects will be randomly selected to receive the local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasoneadministered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery. 0.25 % bupivacaine (2.5 mg/ml) w/ 1:100,000 epinephrine \& 4 mg dexamethasone: If randomized to this arm, subjects will receive a selective block with a local anesthetic solution containing 0.25 % bupivacaine. (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone intraoperatively.
Length of Hospital Stay	1 Days Interval 1.0 to 1.0	1 Days Interval 1.0 to 1.0

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

0.25 % Bupivacaine w/ Epinephrine & 4mg Dexamethasone

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

Dr. Mohammed Alghoul

Northwestern Memorial Hospital

Email: malghoul@nm.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place