Pain, PostoperativePhase 1NCT01688596
Injection of Local Anesthetic to Trocar Insertion Sites After Laparoscopy
A Phase 1 study testing Bupivacaine in people with Pain, Postoperative, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Jan 2013
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Infiltration of Bupivacaine Local Anesthetic to Trocar Insertion Sites After Laparoscopic Hysterectomy: A Randomized, Double-Blind, Placebo-Controlled Trial
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.
Read the detailed description
The growing interest in minimally invasive gynecologic surgeries have increased the number of patients undergoing laparoscopic hysterectomies. Although many patients are being discharged home the same day of surgery, majority of patients complain of immediate postoperative pain after a laparoscopic hysterectomy. Since postoperative pain is usually transient and improves over a short period of time, infiltration of local anesthetic to trocar insertion sites might alleviate the patient's discomfort during the recovery period. Immediate post-operative pain relief further facilitates early discharge and faster patient recovery.
Published data regarding the effects of preemptive port site local anesthesia in gynecologic operative laparoscopy have been limited and controversial. Visceral pain control through afferent nerve block could minimize pain perception especially during the first postoperative hours. This study aims to assess the influence of infiltration of local anesthetic to trocar insertion sites after laparoscopic hysterectomy on postoperative pain.
- Conditions
- Pain, Postoperative
- Being tested
- Bupivacaine
- Keywords
- Local, Anesthesia, Pain, Laparoscopic hysterectomy, Trocar site, Port site
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Marcaine
Bupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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".
Measured: 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".
Measured: 24 hours
Secondary outcomes (5)
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.
Measured: day of surgery after procedure completion
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.
Measured: From date of randomization up to 12 months
Operating Time
Operating time measured in minutes
Measured: start to end of patient's surgery
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.
Measured: from time surgery completed to time patient discharged
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.
Measured: Histopathologic diagnosis will be measured on the day of surgery after completing the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Davies, Milton S. Hershey Medical Center
- Investigators
- Gerald Harkins, MD, Study director, Milton S. Hershey Medical CenterMaria Teresa Tam, MD, Principal investigator, Milton S. Hershey Medical CenterMatthew Davies, MD, Study chair, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01688596
- Sponsor's protocol ID
- 40708
- Status last verified
- Mar 2018
- First submitted
- 7 Sep 2012
- Last updated
- 9 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 15572499Kim 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.
PubMed 16104440Saleh 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.
PubMed 11342725Ghezzi 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.
PubMed 15922977Marks 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.
PubMed 22763313Chou 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.
PubMed 16036193Fong 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.
PubMed 11251136Ke 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.
PubMed 9840560Salman 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.
PubMed 10786738Goldstein 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.
PubMed 10910857
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infiltration of Bupivacaine Local Anesthetic to Trocar Insertion Sites After Laparoscopic Hysterectomy: A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT01688596
- Acronym / sponsor ID
- 40708
- Conditions
- Pain, Postoperative
- Keywords
- Local, Anesthesia, Pain, Laparoscopic hysterectomy, Trocar site, Port site
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 20 Sep 2012 (estimated)
- Results
- Posted 9 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The growing interest in minimally invasive gynecologic surgeries have increased the number of patients undergoing laparoscopic hysterectomies. Although many patients are being discharged home the same day of surgery, majority of patients complain of immediate postoperative pain after a laparoscopic hysterectomy. Since postoperative pain is usually transient and improves over a short period of time, infiltration of local anesthetic to trocar insertion sites might alleviate the patient's discomfort during the recovery period. Immediate post-operative pain relief further facilitates early discharge and faster patient recovery.
Published data regarding the effects of preemptive port site local anesthesia in gynecologic operative laparoscopy have been limited and controversial. Visceral pain control through afferent nerve block could minimize pain perception especially during the first postoperative hours. This study aims to assess the influence of infiltration of local anesthetic to trocar insertion sites after laparoscopic hysterectomy on postoperative pain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Treatment | No intervention | –The "No Treatment" group includes patients undergoing laparoscopic hysterectomy without local infiltration of bupivacaine. |
| Bupivacaine | Active comparator | Drug: BupivacaineThe "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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BupivacaineAlso: MarcaineBupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case. | Drug | Bupivacaine |
Primary outcome
Postoperative Pain Score Evaluated by Numerical Rating Scale (NRS)
Time frame: 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".
Postoperative Pain Score
Time frame: 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".
Postoperative Pain Score
Time frame: 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".
5 secondary outcomes
Estimated Blood Loss > 200 mL
Time frame: day of surgery after procedure completion
Surgical Complications
Time frame: From date of randomization up to 12 months
Operating Time
Time frame: start to end of patient's surgery
Length of Hospital Stay >= 24 Hours
Time frame: from time surgery completed to time patient discharged
Histopathologic Diagnosis
Time frame: Histopathologic diagnosis will be measured on the day of surgery after completing the procedure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15572499Einarsson 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.
- Background: PubMed 16104440Kim 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.
- Background: PubMed 11342725Saleh 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.
- Background: PubMed 15922977Ghezzi 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.
- Background: PubMed 22763313Marks 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.
- Background: PubMed 16036193Chou 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.
- Background: PubMed 11251136Fong 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.
- Background: PubMed 9840560Ke 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.
- Background: PubMed 10786738Salman 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.
- Background: PubMed 10910857Goldstein 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.
- Individual participant dataSharing planned: No
Related trials for Pain, Postoperative
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerald Harkins, MD study director
Milton S. Hershey Medical Center
Maria Teresa Tam, MD principal investigator
Milton S. Hershey Medical Center
Matthew Davies, MD study chair
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bupivacaine in people with Pain, Postoperative, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Score Evaluated by Numerical Rating Scale (NRS) (time frame: 4 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01688596, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2019.