Trial Outcomes & Findings for Injection of Local Anesthetic to Trocar Insertion Sites After Laparoscopy (NCT NCT01688596)

Results Overview

Postoperative pain is measured on day of surgery after trocar incisions are closed and injected with local anesthetic. Postoperative pain is evaluated with the Numerical Rating Scale (NRS) at 4 hrs after the surgery. The Numerical Rating Scale is a scale from 0 to 10 that measures pain severity, where 0 equates to "no pain" and 10 equates to "unable to move".

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

135 participants

Primary outcome timeframe

4 hours

Results posted on

2019-09-09

Participant Flow

Patients undergoing laparoscopic surgery at Penn State Milton S. Hershey Medical Center were recruited between 3/13 and 6/13. Allocated to CPP or no CPP based on usual clinical definitions.

Patients in each group (Chronic Pelvic Pain and No Chronic Pelvic Pain) were randomized to receive either a bupivacaine block at each trocar site or no block. Standardization of amount of local block received was based on trocar size of 5mm or less vs. 8mm and or greater.

Participant milestones

Participant milestones
Measure	No Treatment The "No Treatment" group includes patients undergoing laparoscopic hysterectomy without local infiltration of bupivacaine.	Bupivacaine The "Bupivacaine Arm" includes all patients who will receive bupivacaine injection on their trocar sites after the laparoscopic hysterectomy is completed. Bupivacaine (0.25%) will be injected through the closed incisions ensuring subcutaneous tissue, fascia, muscle and pre-peritoneal space of the trocar incision sites are infiltrated. All incisions 8 mm and greater are injected with 10 cc while all incisions 5 mm or less are infiltrated with 5 cc. Bupivacaine: Bupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case.
Overall Study STARTED	67	68
Overall Study COMPLETED	59	59
Overall Study NOT COMPLETED	8	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Injection of Local Anesthetic to Trocar Insertion Sites After Laparoscopy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	No Treatment n=67 Participants The "No Treatment" group includes patients undergoing laparoscopic hysterectomy without local infiltration of bupivacaine.	Bupivacaine n=68 Participants The "Bupivacaine Arm" includes all patients who will receive bupivacaine injection on their trocar sites after the laparoscopic hysterectomy is completed. Bupivacaine (0.25%) will be injected through the closed incisions ensuring subcutaneous tissue, fascia, muscle and pre-peritoneal space of the trocar incision sites are infiltrated. All incisions 8 mm and greater are injected with 10 cc while all incisions 5 mm or less are infiltrated with 5 cc. Bupivacaine: Bupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case.	Total n=135 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	67 Participants n=93 Participants	68 Participants n=4 Participants	135 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	38.3 years STANDARD_DEVIATION 8.4 • n=93 Participants	38.6 years STANDARD_DEVIATION 10.5 • n=4 Participants	38.5 years STANDARD_DEVIATION 9.5 • n=27 Participants
Sex: Female, Male Female	67 Participants n=93 Participants	68 Participants n=4 Participants	135 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	67 participants n=93 Participants	68 participants n=4 Participants	135 participants n=27 Participants
Parity	67 Participants n=93 Participants	68 Participants n=4 Participants	135 Participants n=27 Participants
Chronic Pelvic Pain	36 participants n=93 Participants	35 participants n=4 Participants	71 participants n=27 Participants

PRIMARY outcome

Timeframe: 4 hours

Postoperative pain is measured on day of surgery after trocar incisions are closed and injected with local anesthetic. Postoperative pain is evaluated with the Numerical Rating Scale (NRS) at 4 hrs after the surgery. The Numerical Rating Scale is a scale from 0 to 10 that measures pain severity, where 0 equates to "no pain" and 10 equates to "unable to move".

Outcome measures

Outcome measures
Measure	No Treatment n=65 Participants The "No Treatment" group includes patients undergoing laparoscopic hysterectomy without local infiltration of bupivacaine.	Bupivacaine n=59 Participants The "Bupivacaine Arm" includes all patients who will receive bupivacaine injection on their trocar sites after the laparoscopic hysterectomy is completed. Bupivacaine (0.25%) will be injected through the closed incisions ensuring subcutaneous tissue, fascia, muscle and pre-peritoneal space of the trocar incision sites are infiltrated. All incisions 8 mm and greater are injected with 10 cc while all incisions 5 mm or less are infiltrated with 5 cc. Bupivacaine: Bupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case.
Postoperative Pain Score Evaluated by Numerical Rating Scale (NRS)	4.1 units on a scale Standard Deviation 2.4	3.4 units on a scale Standard Deviation 2.6

PRIMARY outcome

Timeframe: 6 hours

Postoperative pain is measured on day of surgery after trocar incisions are closed and injected with local anesthetic. Postoperative pain is evaluated with the Numerical Rating Scale (NRS) at 6 hrs after the surgery. The Numerical Rating Scale is a scale from 0 to 10 that measures pain severity, where 0 equates to "no pain" and 10 equates to "unable to move".

Outcome measures

Outcome measures
Measure	No Treatment n=43 Participants The "No Treatment" group includes patients undergoing laparoscopic hysterectomy without local infiltration of bupivacaine.	Bupivacaine n=40 Participants The "Bupivacaine Arm" includes all patients who will receive bupivacaine injection on their trocar sites after the laparoscopic hysterectomy is completed. Bupivacaine (0.25%) will be injected through the closed incisions ensuring subcutaneous tissue, fascia, muscle and pre-peritoneal space of the trocar incision sites are infiltrated. All incisions 8 mm and greater are injected with 10 cc while all incisions 5 mm or less are infiltrated with 5 cc. Bupivacaine: Bupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case.
Postoperative Pain Score	4.7 units on a scale Standard Deviation 2.3	4.3 units on a scale Standard Deviation 2.1

PRIMARY outcome

Timeframe: 24 hours

Postoperative pain is measured on day of surgery after trocar incisions are closed and injected with local anesthetic. Postoperative pain is evaluated with the Numerical Rating Scale (NRS) at 24 hrs after the surgery. The Numerical Rating Scale is a scale from 0 to 10 that measures pain severity, where 0 equates to "no pain" and 10 equates to "unable to move".

Outcome measures

Outcome measures
Measure	No Treatment n=29 Participants The "No Treatment" group includes patients undergoing laparoscopic hysterectomy without local infiltration of bupivacaine.	Bupivacaine n=28 Participants The "Bupivacaine Arm" includes all patients who will receive bupivacaine injection on their trocar sites after the laparoscopic hysterectomy is completed. Bupivacaine (0.25%) will be injected through the closed incisions ensuring subcutaneous tissue, fascia, muscle and pre-peritoneal space of the trocar incision sites are infiltrated. All incisions 8 mm and greater are injected with 10 cc while all incisions 5 mm or less are infiltrated with 5 cc. Bupivacaine: Bupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case.
Postoperative Pain Score	3.5 units on a scale Standard Deviation 2.4	4.0 units on a scale Standard Deviation 1.8

SECONDARY outcome

Timeframe: day of surgery after procedure completion

Estimated blood loss will be measured in (mL) on the day of surgery after completing the procedure. Blood loss will be categorized as \>200 mL vs. \<= 200 mL.

Outcome measures

Outcome measures
Measure	No Treatment n=67 Participants The "No Treatment" group includes patients undergoing laparoscopic hysterectomy without local infiltration of bupivacaine.	Bupivacaine n=67 Participants The "Bupivacaine Arm" includes all patients who will receive bupivacaine injection on their trocar sites after the laparoscopic hysterectomy is completed. Bupivacaine (0.25%) will be injected through the closed incisions ensuring subcutaneous tissue, fascia, muscle and pre-peritoneal space of the trocar incision sites are infiltrated. All incisions 8 mm and greater are injected with 10 cc while all incisions 5 mm or less are infiltrated with 5 cc. Bupivacaine: Bupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case.
Estimated Blood Loss > 200 mL	2 Participants	2 Participants

SECONDARY outcome

Timeframe: From date of randomization up to 12 months

Intraoperative complications include injury to bowel, bladder, blood vessels, nerves and hemorrhage. Perioperative complications include urinary tract infections, urinary retention, ileus, myocardial infarction, atrial fibrillation, pulmonary edema, atelectasis, pneumonia, renal and cerebrovascular morbidity, thromboembolic complications (DVT and PE). Postoperative complications include pulmonary, renal, and cerebrovascular morbidity, wound and vaginal vault complications (infection, separation, and dehiscence), septicemia, thromboembolic events, and re-operation.

Outcome measures

Outcome measures
Measure	No Treatment n=67 Participants The "No Treatment" group includes patients undergoing laparoscopic hysterectomy without local infiltration of bupivacaine.	Bupivacaine n=68 Participants The "Bupivacaine Arm" includes all patients who will receive bupivacaine injection on their trocar sites after the laparoscopic hysterectomy is completed. Bupivacaine (0.25%) will be injected through the closed incisions ensuring subcutaneous tissue, fascia, muscle and pre-peritoneal space of the trocar incision sites are infiltrated. All incisions 8 mm and greater are injected with 10 cc while all incisions 5 mm or less are infiltrated with 5 cc. Bupivacaine: Bupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case.
Surgical Complications	0 Participants	0 Participants

SECONDARY outcome

Timeframe: start to end of patient's surgery

Operating time measured in minutes

Outcome measures

Outcome measures
Measure	No Treatment n=67 Participants The "No Treatment" group includes patients undergoing laparoscopic hysterectomy without local infiltration of bupivacaine.	Bupivacaine n=67 Participants The "Bupivacaine Arm" includes all patients who will receive bupivacaine injection on their trocar sites after the laparoscopic hysterectomy is completed. Bupivacaine (0.25%) will be injected through the closed incisions ensuring subcutaneous tissue, fascia, muscle and pre-peritoneal space of the trocar incision sites are infiltrated. All incisions 8 mm and greater are injected with 10 cc while all incisions 5 mm or less are infiltrated with 5 cc. Bupivacaine: Bupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case.
Operating Time	73.3 minutes Standard Deviation 33.9	63.8 minutes Standard Deviation 24.5

SECONDARY outcome

Timeframe: from time surgery completed to time patient discharged

Length of hospital stay will be measured on the day of surgery after completing the procedure to when the patient is discharged from the hospital. Length of stay will be categorized as less than 24 hours vs. greater than or equal to 24 hours.

Outcome measures

Outcome measures
Measure	No Treatment n=67 Participants The "No Treatment" group includes patients undergoing laparoscopic hysterectomy without local infiltration of bupivacaine.	Bupivacaine n=67 Participants The "Bupivacaine Arm" includes all patients who will receive bupivacaine injection on their trocar sites after the laparoscopic hysterectomy is completed. Bupivacaine (0.25%) will be injected through the closed incisions ensuring subcutaneous tissue, fascia, muscle and pre-peritoneal space of the trocar incision sites are infiltrated. All incisions 8 mm and greater are injected with 10 cc while all incisions 5 mm or less are infiltrated with 5 cc. Bupivacaine: Bupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case.
Length of Hospital Stay >= 24 Hours	36 Participants	30 Participants

SECONDARY outcome

Timeframe: Histopathologic diagnosis will be measured on the day of surgery after completing the procedure.

Histopathologic diagnosis describes the findings seen on tissue pathology and microscopy and is defined as one of the following: endometriosis, leiomyoma, adenomyosis, or other.

Outcome measures

Outcome measures
Measure	No Treatment n=67 Participants The "No Treatment" group includes patients undergoing laparoscopic hysterectomy without local infiltration of bupivacaine.	Bupivacaine n=67 Participants The "Bupivacaine Arm" includes all patients who will receive bupivacaine injection on their trocar sites after the laparoscopic hysterectomy is completed. Bupivacaine (0.25%) will be injected through the closed incisions ensuring subcutaneous tissue, fascia, muscle and pre-peritoneal space of the trocar incision sites are infiltrated. All incisions 8 mm and greater are injected with 10 cc while all incisions 5 mm or less are infiltrated with 5 cc. Bupivacaine: Bupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case.
Histopathologic Diagnosis Endometriosis	26 Participants	21 Participants
Histopathologic Diagnosis Leiomyoma	10 Participants	12 Participants
Histopathologic Diagnosis Adenomyosis	5 Participants	3 Participants
Histopathologic Diagnosis Other	26 Participants	31 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Surgical findings will be measured on the day of surgery after completing the procedure.

The primary intra-operative finding found during surgery, defined as one of the following: endometriosis, pelvic adhesive disease, leiomyoma, or other.

Outcome measures

Outcome measures
Measure	No Treatment n=67 Participants The "No Treatment" group includes patients undergoing laparoscopic hysterectomy without local infiltration of bupivacaine.	Bupivacaine n=67 Participants The "Bupivacaine Arm" includes all patients who will receive bupivacaine injection on their trocar sites after the laparoscopic hysterectomy is completed. Bupivacaine (0.25%) will be injected through the closed incisions ensuring subcutaneous tissue, fascia, muscle and pre-peritoneal space of the trocar incision sites are infiltrated. All incisions 8 mm and greater are injected with 10 cc while all incisions 5 mm or less are infiltrated with 5 cc. Bupivacaine: Bupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case.
Primary Surgical Finding Endometriosis	37 Participants	41 Participants
Primary Surgical Finding Pelvic adhesive disease	12 Participants	5 Participants
Primary Surgical Finding Leiomyoma	6 Participants	9 Participants
Primary Surgical Finding Other	12 Participants	12 Participants

Adverse Events

No Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bupivacaine

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. Matthew F. Davies, M.D.

Penn State Milton S. Hershey Medical Center

Phone: 7175310003

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place