Pain, Postoperative Clinical Trial
Official title:
Infiltration of Bupivacaine Local Anesthetic to Trocar Insertion Sites After Laparoscopic Hysterectomy: A Randomized, Double-Blind, Placebo-Controlled Trial
NCT number | NCT01688596 |
Other study ID # | 40708 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | September 2012 |
Est. completion date | January 2013 |
Verified date | March 2018 |
Source | Milton S. Hershey Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 135 |
Est. completion date | January 2013 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Milton S. Hershey Medical Center |
United States,
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. — View Citation
Einarsson JI, Sun J, Orav J, Young AE. Local analgesia in laparoscopy: a randomized trial. Obstet Gynecol. 2004 Dec;104(6):1335-9. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
Salman MA, Yücebas 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Primary Surgical Finding | The primary intra-operative finding found during surgery, defined as one of the following: endometriosis, pelvic adhesive disease, leiomyoma, or other. | Surgical findings will be measured on the day of surgery after completing the procedure. | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Estimated Blood Loss > 200 mL | 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. | day of surgery after procedure completion | |
Secondary | Surgical Complications | 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. | From date of randomization up to 12 months | |
Secondary | Operating Time | Operating time measured in minutes | start to end of patient's surgery | |
Secondary | Length of Hospital Stay >= 24 Hours | 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. | from time surgery completed to time patient discharged | |
Secondary | Histopathologic Diagnosis | Histopathologic diagnosis describes the findings seen on tissue pathology and microscopy and is defined as one of the following: endometriosis, leiomyoma, adenomyosis, or other. | Histopathologic diagnosis will be measured on the day of surgery after completing the procedure. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05480111 -
The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy
|
Phase 4 | |
Completed |
NCT06129305 -
Erector Spina Muscle Distance From the Skin at Different Thoracal Elevations
|
||
Completed |
NCT04401826 -
Micro-surgical Treatment of Gummy Smile
|
N/A | |
Recruiting |
NCT04020133 -
the Role of Popliteal Plexus Block in Pain Management After Anterior Cruciate Ligament Reconstruction.
|
N/A | |
Completed |
NCT03023462 -
Efficacy of an Anterior Quadratus Lumborum Block vs. a TAP-block for Inguinal Hernia Repair
|
N/A | |
Completed |
NCT03546738 -
Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery
|
N/A | |
Completed |
NCT03652103 -
Efficiency of Erector Spinae Plane Block For Patients Undergoing Percutaneous Nephrolithotomy
|
Phase 4 | |
Recruiting |
NCT03261193 -
ITM + Bupivacaine QLB vs. ITM + Sham Saline QLB for Cesarean Delivery Pain
|
Phase 3 | |
Withdrawn |
NCT03528343 -
Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy
|
Phase 1/Phase 2 | |
Completed |
NCT02525133 -
Phase 3 Study of Efficacy and Safety of the XaraColl® Bupivacaine Implant After Hernioplasty
|
Phase 3 | |
Completed |
NCT03244540 -
Regional Analgesia After Cesarean Section
|
Phase 4 | |
Enrolling by invitation |
NCT05316168 -
Post Operative Pain Management for ACL Reconstruction
|
Phase 3 | |
Recruiting |
NCT04130464 -
Intraperitoneal Infusion of Analgesic for Postoperative Pain Management
|
Phase 4 | |
Enrolling by invitation |
NCT04574791 -
Addition of Muscle Relaxants in a Multimodal Analgesic Regimen for Analgesia After Primary Total Knee Arthroplasty
|
N/A | |
Completed |
NCT04073069 -
Scalp Infiltration With Diprospan Plus Ropivacaine for Postoperative Pain After Craniotomy in Adults
|
Phase 4 | |
Completed |
NCT04526236 -
Influence of Aging on Perioperative Methadone Dosing
|
Phase 4 | |
Recruiting |
NCT05351229 -
Intrathecal Morphine for Analgesia in Video-assisted Thoracic Surgery
|
Phase 4 | |
Enrolling by invitation |
NCT05543109 -
Ultrasound Guided Psoas Compartment Block vs Suprainguinal Fascia Iliaca Compartment Block
|
N/A | |
Completed |
NCT05346588 -
THRIVE Feasibility Trial
|
Phase 3 | |
Completed |
NCT04919317 -
Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty
|
Phase 2 |