Injection of Local Anesthetic to Trocar Insertion Sites After Laparoscopy

NCT01688596 | Completed Phase 1 Results DMC

• 1 other identifier: 40708
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to assess if injection of local anesthetic to the laparoscopic trocar sites after a hysterectomy will make a difference in a patient's pain after surgery.

Conditions

Pain, Postoperative

Keywords

Local; Anesthesia; Pain; Laparoscopic hysterectomy; Trocar site; Port site

Outcome Measures

Primary Outcomes (3)

• Postoperative Pain Score Evaluated by Numerical Rating Scale (NRS)

  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".

  4 hours

• Postoperative Pain Score

  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".

  6 hours

• Postoperative Pain Score

  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".

  24 hours

Secondary Outcomes (5)

• Estimated Blood Loss > 200 mL

  day of surgery after procedure completion

• Surgical Complications

  From date of randomization up to 12 months

• Operating Time

  start to end of patient's surgery

• Length of Hospital Stay >= 24 Hours

  from time surgery completed to time patient discharged

• Histopathologic Diagnosis

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

Other Outcomes (1)

• Primary Surgical Finding

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

Study Arms (2)

No Treatment

NO INTERVENTION

The "No Treatment" group includes patients undergoing laparoscopic hysterectomy without local infiltration of bupivacaine.

Bupivacaine

ACTIVE COMPARATOR

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.

Drug: Bupivacaine

Interventions

Bupivacaine DRUG

Bupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case.

Also known as: Marcaine

Bupivacaine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are scheduled for a laparoscopic hysterectomy for benign indications at the Department of Obstetrics \& Gynecology's Division of Minimally Invasive Surgery at Milton S. Hershey Medical Center will be included.

You may not qualify if:

• Patients who are scheduled for a hysterectomy through the vaginal or abdominal approach will be excluded. Patients with preoperative indications of endometriosis or chronic pelvic pain will also be excluded since these patients could potentially have higher thresholds of pain.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (10)

• Einarsson JI, Sun J, Orav J, Young AE. Local analgesia in laparoscopy: a randomized trial. Obstet Gynecol. 2004 Dec;104(6):1335-9. doi: 10.1097/01.AOG.0000146283.90934.fd.

  PMID: 15572499 BACKGROUND

• Kim JH, Lee YS, Shin HW, Chang MS, Park YC, Kim WY. Effect of administration of ketorolac and local anaesthetic infiltration for pain relief after laparoscopic-assisted vaginal hysterectomy. J Int Med Res. 2005 Jul-Aug;33(4):372-8. doi: 10.1177/147323000503300402.

  PMID: 16104440 BACKGROUND

• Saleh A, Fox G, Felemban A, Guerra C, Tulandi T. Effects of local bupivacaine instillation on pain after laparoscopy. J Am Assoc Gynecol Laparosc. 2001 May;8(2):203-6. doi: 10.1016/s1074-3804(05)60578-6.

  PMID: 11342725 BACKGROUND

• Ghezzi F, Cromi A, Bergamini V, Raffaelli R, Crotti S, Segredini R, Bolis P. Preemptive port site local anesthesia in gynecologic laparoscopy: a randomized, controlled trial. J Minim Invasive Gynecol. 2005 May-Jun;12(3):210-5. doi: 10.1016/j.jmig.2005.03.007.

  PMID: 15922977 BACKGROUND

• Marks JL, Ata B, Tulandi T. Systematic review and metaanalysis of intraperitoneal instillation of local anesthetics for reduction of pain after gynecologic laparoscopy. J Minim Invasive Gynecol. 2012 Sep-Oct;19(5):545-53. doi: 10.1016/j.jmig.2012.04.002. Epub 2012 Jul 3.

  PMID: 22763313 BACKGROUND

• Chou YJ, Ou YC, Lan KC, Jawan B, Chang SY, Kung FT. Preemptive analgesia installation during gynecologic laparoscopy: a randomized trial. J Minim Invasive Gynecol. 2005 Jul-Aug;12(4):330-5. doi: 10.1016/j.jmig.2005.05.005.

  PMID: 16036193 BACKGROUND

• Fong SY, Pavy TJ, Yeo ST, Paech MJ, Gurrin LC. Assessment of wound infiltration with bupivacaine in women undergoing day-case gynecological laparoscopy. Reg Anesth Pain Med. 2001 Mar-Apr;26(2):131-6. doi: 10.1053/rapm.2001.21836.

  PMID: 11251136 BACKGROUND

• Ke RW, Portera SG, Bagous W, Lincoln SR. A randomized, double-blinded trial of preemptive analgesia in laparoscopy. Obstet Gynecol. 1998 Dec;92(6):972-5. doi: 10.1016/s0029-7844(98)00303-2.

  PMID: 9840560 BACKGROUND

• Salman MA, Yucebas ME, Coskun F, Aypar U. Day-case laparoscopy: a comparison of prophylactic opioid, NSAID or local anesthesia for postoperative analgesia. Acta Anaesthesiol Scand. 2000 May;44(5):536-42. doi: 10.1034/j.1399-6576.2000.00508.x.

  PMID: 10786738 BACKGROUND

• Goldstein A, Grimault P, Henique A, Keller M, Fortin A, Darai E. Preventing postoperative pain by local anesthetic instillation after laparoscopic gynecologic surgery: a placebo-controlled comparison of bupivacaine and ropivacaine. Anesth Analg. 2000 Aug;91(2):403-7. doi: 10.1097/00000539-200008000-00032.

  PMID: 10910857 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Matthew F. Davies, M.D.
• Organization: Penn State Milton S. Hershey Medical Center

mdavies@hmc.psu.edu

7175310003

Study Officials

• Gerald Harkins, MD

  Milton S. Hershey Medical Center

  STUDY DIRECTOR

• Maria Teresa Tam, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

• Matthew Davies, MD

  Milton S. Hershey Medical Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Division of Urogynecology and Minimally Invasive GYN Surgery

Study Record Dates

• First Submitted: September 7, 2012
• First Posted: September 20, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: January 1, 2013
• Last Updated: September 9, 2019
• Results First Posted: September 9, 2019

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)