Pain, PostoperativeEarly Phase 1NCT03268525
The Effect of Local Anesthesia on Postoperative Pain in Vaginal Hysterectomy
A Early Phase 1 study testing Marcaine 0.5 % Injectable Solution and Sodium Chloride 0.9% in people with Pain, Postoperative, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
The investigators aim is to study the effect of pre-operative local anesthetic on post vaginal hysterectomy pain. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Marcaine 0.5 % Injectable Solution and Sodium Chloride 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Sep 2017to 30 Nov 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elective vaginal hysterectomy on benign indication
Who cannot join
- additional abdominal, chronic pelvic pain, malignancy, and allergy to Bupivacaine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Local Anesthesia on Postoperative Pain in Vaginal Hysterectomy: A Randomized Controlled Trial
The investigators aim is to study the effect of pre-operative local anesthetic on post vaginal hysterectomy pain.
Read the detailed description
This is a double-blinded, randomized, controlled trial. Women who undergone elective vaginal hysterectomy and gave their informed consent were included. Exclusion criteria included additional abdominal, chronic pelvic pain, malignancy, and allergy to Bupivacaine.
Solutions of either Bupivacaine-Hydrochloride 0.5%, or Sodium-Chloride 0.9% as a placebo, were prepared prior to surgery, according to randomization. The chosen solution was injected before incision, as a modified paracervical block, and in each resection line (sacro-uterine and cardinal ligaments). The amount of fluid administered was 10 ml. When colporrhaphy was also performed, an additional 5 ml of solution were injected in the midline of the vaginal wall prior to each incision line.
By utilizing the 10 cm Visual-analogue-scale (VAS) we examined the differences in post-operative pain at rest at 3, 8, and 24 hours, and during ambulation at 8 and 24 hours using multivariate linear regression models. We also assessed the differences in analgesics given at the different time points between the groups using multivariate negative binomial regression models.
- Conditions
- Pain, Postoperative
- Being tested
- Marcaine 0.5 % Injectable Solution, Sodium Chloride 0.9%
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marcaine 0.5 % Injectable SolutionDrug
Also called Study
Local infiltration by Marcaine 0.5% Injectable Solution prior to incision
Sodium Chloride 0.9%Drug
Also called Placebo
Local infiltration by Sodium Chloride 0.9% prior to incision
| Study group | Role | What they receive |
|---|---|---|
| Study | Active comparator | Marcaine 0.5 % Injectable Solution will be injected before incision, and in a systematic fashion as a modified paracervical block. First, 2 ml will be injected through the vaginal fornices at 03.00, 06.00, 09.00, and 12.00 hours at 2 cm depth. Thus, 8 ml will be systematically injected around the cervical circumference before incision. In addition, 1 ml of the solution will be injected in each resection line (sacro-uterine and cardinal ligaments), adding up to a total of 10 ml. In case of performing additional anterior/ posterior colporrhaphy, additional solution of Marcaine 0.25%will be prepared: 5 ml of the solution will be injected to the cutting line of the anterior/ posterior vaginal wall, respectively, prior to incision. Receives: Drug: Marcaine 0.5 % Injectable Solution |
| Control | Placebo comparator | Sodium Chloride 0.9% will be injected before incision, and in a systematic fashion as a modified paracervical block. First, 2 ml will be injected through the vaginal fornices at 03.00, 06.00, 09.00, and 12.00 hours at 2 cm depth. Thus, 8 ml will be systematically injected around the cervical circumference before incision. In addition, 1 ml of the solution will be injected in each resection line (sacro-uterine and cardinal ligaments), adding up to a total of 10 ml. In case of performing additional anterior/ posterior colporrhaphy, additional solution of Sodium Chloride 0.9% will be prepared: 5 ml of the solution will be injected to the cutting line of the anterior/ posterior vaginal wall, respectively, prior to incision. Receives: Drug: Sodium Chloride 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain at movement
Movement-evoked pain will be scored after the operation
Measured: 24 hours
Secondary outcomes (1)
pain at rest
Pain at rest will be scored with the woman lying in bed after the operation
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start1 Sep 2017
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Drug group versus placebo group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ohad Gluck, Wolfson Medical Center
- Investigators
- Shimon Ginat, MD, Study director, Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03268525
- Sponsor's protocol ID
- 0156-17-WOMC
- Status last verified
- Jun 2020
- First submitted
- 22 Aug 2017
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Local Anesthesia on Postoperative Pain in Vaginal Hysterectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03268525
- Acronym / sponsor ID
- 0156-17-WOMC
- Conditions
- Pain, Postoperative
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 31 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aim is to study the effect of pre-operative local anesthetic on post vaginal hysterectomy pain.
Detailed description
This is a double-blinded, randomized, controlled trial. Women who undergone elective vaginal hysterectomy and gave their informed consent were included. Exclusion criteria included additional abdominal, chronic pelvic pain, malignancy, and allergy to Bupivacaine.
Solutions of either Bupivacaine-Hydrochloride 0.5%, or Sodium-Chloride 0.9% as a placebo, were prepared prior to surgery, according to randomization. The chosen solution was injected before incision, as a modified paracervical block, and in each resection line (sacro-uterine and cardinal ligaments). The amount of fluid administered was 10 ml. When colporrhaphy was also performed, an additional 5 ml of solution were injected in the midline of the vaginal wall prior to each incision line.
By utilizing the 10 cm Visual-analogue-scale (VAS) we examined the differences in post-operative pain at rest at 3, 8, and 24 hours, and during ambulation at 8 and 24 hours using multivariate linear regression models. We also assessed the differences in analgesics given at the different time points between the groups using multivariate negative binomial regression models.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Drug group versus placebo group
| Arm | Type | Receives |
|---|---|---|
| Study | Active comparator | Drug: Marcaine 0.5 % Injectable SolutionMarcaine 0.5 % Injectable Solution will be injected before incision, and in a systematic fashion as a modified paracervical block. First, 2 ml will be injected through the vaginal fornices at 03.00, 06.00, 09.00, and 12.00 hours at 2 cm depth. Thus, 8 ml will be systematically injected around the cervical circumference before incision. In addition, 1 ml of the solution will be injected in each resection line (sacro-uterine and cardinal ligaments), adding up to a total of 10 ml. In case of performing additional anterior/ posterior colporrhaphy, additional solution of Marcaine 0.25%will be prepared: 5 ml of the solution will be injected to the cutting line of the anterior/ posterior vaginal wall, respectively, prior to incision. |
| Control | Placebo comparator | Drug: Sodium Chloride 0.9%Sodium Chloride 0.9% will be injected before incision, and in a systematic fashion as a modified paracervical block. First, 2 ml will be injected through the vaginal fornices at 03.00, 06.00, 09.00, and 12.00 hours at 2 cm depth. Thus, 8 ml will be systematically injected around the cervical circumference before incision. In addition, 1 ml of the solution will be injected in each resection line (sacro-uterine and cardinal ligaments), adding up to a total of 10 ml. In case of performing additional anterior/ posterior colporrhaphy, additional solution of Sodium Chloride 0.9% will be prepared: 5 ml of the solution will be injected to the cutting line of the anterior/ posterior vaginal wall, respectively, prior to incision. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective vaginal hysterectomy on benign indication
Key exclusion criteria (1 listed)
- additional abdominal, chronic pelvic pain, malignancy, and allergy to Bupivacaine.
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 |
|---|---|---|
| Marcaine 0.5 % Injectable SolutionAlso: StudyLocal infiltration by Marcaine 0.5% Injectable Solution prior to incision | Drug | Study |
| Sodium Chloride 0.9%Also: PlaceboLocal infiltration by Sodium Chloride 0.9% prior to incision | Drug | Control |
Primary outcome
Pain at movement
Time frame: 24 hours
Movement-evoked pain will be scored after the operation
1 secondary outcome
pain at rest
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Individual participant dataSharing planned: No
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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.
Shimon Ginat, MD study director
Wolfson Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Marcaine 0.5 % Injectable Solution and Sodium Chloride 0.9% in people with Pain, Postoperative, run by Wolfson Medical Center at 1 site in Israel.
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 Jun 2020. 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 Israel. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain at movement (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2020.