Trial Outcomes & Findings for Effects of Local Anesthesia on Post-operative Pain During Laparoscopic Inguinal Hernia Repair (NCT NCT02055053)

NCT ID: NCT02055053

Last Updated: 2022-01-11

Results Overview

Pain level at 4 hours after surgery VAS scale measures pain in whole numbers from 0 (no pain) to 10 (worst imaginable pain)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 70 participants
• Primary outcome timeframe: Post-operative period
• Results posted on: 2022-01-11

Participant Flow

Participant milestones

Measure	Anesthetic Intervention After deployment of therapeutic mesh in the preperitoneal space of the abdomen wall during the procedure, the treatment group will receive infusion of 15 cc 0.5% Bupivicaine. 0.5% Bupivicaine: Local anesthetic	Saline Intervention After deployment of therapeutic mesh in the preperitoneal space of the abdomen wall during the procedure, the placebo group will receive the infusion of 15 cc 0.9% Saline. 0.5% Bupivicaine: Local anesthetic
Overall Study STARTED	35	35
Overall Study COMPLETED	35	35
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Local Anesthesia on Post-operative Pain During Laparoscopic Inguinal Hernia Repair

Baseline characteristics by cohort

Measure	Anesthetic Intervention n=35 Participants After deployment of therapeutic mesh in the preperitoneal space of the abdomen wall during the procedure, the treatment group will receive infusion of 15 cc 0.5% Bupivicaine. 0.5% Bupivicaine: Local anesthetic	Saline Intervention n=35 Participants After deployment of therapeutic mesh in the preperitoneal space of the abdomen wall during the procedure, the placebo group will receive the infusion of 15 cc 0.9% Saline. 0.5% Bupivicaine: Local anesthetic	Total n=70 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	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	34 Participants n=7 Participants	67 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	35 Participants n=5 Participants	35 Participants n=7 Participants	70 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants	35 participants n=7 Participants	70 participants n=5 Participants

PRIMARY outcome

Timeframe: Post-operative period

Pain level at 4 hours after surgery VAS scale measures pain in whole numbers from 0 (no pain) to 10 (worst imaginable pain)

Outcome measures

Measure	Anesthetic Intervention n=35 Participants After deployment of therapeutic mesh in the preperitoneal space of the abdomen wall during the procedure, the treatment group will receive infusion of 15 cc 0.5% Bupivicaine. 0.5% Bupivicaine: Local anesthetic	Saline Intervention n=35 Participants After deployment of therapeutic mesh in the preperitoneal space of the abdomen wall during the procedure, the placebo group will receive the infusion of 15 cc 0.9% Saline. 0.5% Bupivicaine: Local anesthetic
Visual Analog Scale Pain Score Assessment (VAS)	2.96 score on a scale Standard Deviation 2.3	3.24 score on a scale Standard Deviation 1.57

PRIMARY outcome

Timeframe: Pain scale 3 days after surgery

Pain level recorded at 3 days after surgery. VAS scale measures pain in increments of whole numbers from 0 (no pain) to 10 (most sever pain imaginable)

Outcome measures

Measure	Anesthetic Intervention n=35 Participants After deployment of therapeutic mesh in the preperitoneal space of the abdomen wall during the procedure, the treatment group will receive infusion of 15 cc 0.5% Bupivicaine. 0.5% Bupivicaine: Local anesthetic	Saline Intervention n=35 Participants After deployment of therapeutic mesh in the preperitoneal space of the abdomen wall during the procedure, the placebo group will receive the infusion of 15 cc 0.9% Saline. 0.5% Bupivicaine: Local anesthetic
Visual Analog Scale Pain Score Assessment (VAS)	3.71 units on a scale Standard Deviation 2.08	3.25 units on a scale Standard Deviation 1.66

SECONDARY outcome

Timeframe: 4 hours after surgery

Population: one patient's data is missing

Total mg of opiate after surgery

Outcome measures

Measure	Anesthetic Intervention n=35 Participants After deployment of therapeutic mesh in the preperitoneal space of the abdomen wall during the procedure, the treatment group will receive infusion of 15 cc 0.5% Bupivicaine. 0.5% Bupivicaine: Local anesthetic	Saline Intervention n=34 Participants After deployment of therapeutic mesh in the preperitoneal space of the abdomen wall during the procedure, the placebo group will receive the infusion of 15 cc 0.9% Saline. 0.5% Bupivicaine: Local anesthetic
Amount of Pain Medication Used in Oral Morphine Equivalents	8.37 oral morphine equivalents Standard Deviation 12.18	7.72 oral morphine equivalents Standard Deviation 10.23

SECONDARY outcome

Timeframe: 4 weeks post-op

Population: Data were not collected for any patients.

Number of days post-operatively narcotic is used

Outcome measures

Outcome data not reported

Adverse Events

Anesthetic Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Saline Intervention

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

dmitry nepomnayshy MD

Lahey Clinic

Phone: 781 744 8576

Email: dmitry.nepomnayshy@lahey.org

Results disclosure agreements

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