Reduce Pain After AppendectomyNCT03189693
Paravertebral Block for Pain Management After Appendectomy
A study testing PVB, GA and Anesthetic injections in people with Reduce Pain After Appendectomy, run by Makassed General Hospital at 1 site in Lebanon.
Trial summary
Paravertebral Block (PVB) was shown to be a successful and useful technique of anesthesia and analgesia. Its effect was evident in thoracic and abdominal surgeries. In the setting of appendectomy, somatic PVB has been used for pediatric patients. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Reduce Pain After Appendectomy
- What is being tested?
- PVB, GA and Anesthetic injections
- 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 siteLebanon
- Study dates
- 1 Jun 2017to Apr 2022
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 18 years
- Scheduled to undergo appendectomy
Who cannot join
- cardiac disease,
- developmental delay,
- neurologic deficit,
- allergies to any of the drugs routinely used in anesthesia management.
Trial locations and contacts
1 site in 1 country.
Lebanon1 site, 1 recruiting
- Recruiting
Makassed General Hospital
Beirut
Zoher Naja, MD, +9611636000 ext. 6941, zouhnaja@yahoo.com
About this study
Official title: Paravertebral Block for Postoperative Pain Management in Adult Patients Undergoing Appendectomy
Paravertebral Block (PVB) was shown to be a successful and useful technique of anesthesia and analgesia. Its effect was evident in thoracic and abdominal surgeries. In the setting of appendectomy, somatic PVB has been used for pediatric patients. It was shown to decrease opioid consumption and provide prolonged pain relief. Hence, it would be beneficial to examine the analgesic effect of PVB on appendectomy in adult patients.
Read the detailed description
Patients undergoing appendectomy will be randomly allocated into two equal groups using the sealed envelope technique. All patients will receive general anesthesia (GA). Patients in group I will receive two PVB injections at levels T12-L1 and L1-L2 using anesthetic mixture, while patients in Group II will receive placebo.
Paravertebral Block Technique Unilateral right side nerve stimulator-guided PVB is performed while patients are in the left lateral decubitis position. The appropriate levels for the PVB are determined by palpation of the spinous processes. An intervertebral line is drawn at the appropriate levels and the injection site is marked 2.5 cm lateral to the midline. After aseptic preparation of the skin, 1 mL 1% lidocaine is infiltrated at the injection sites. A 21-G nerve stimulation needle (Stimuplex; B. Braun, Melsungen, Germany) is advanced 1-2 cm perpendicularly to the skin using a nerve stimulating current of 2.5-5.0 mA, while closely watching for contractions of the abdominal muscles. The tip of the needle is adjusted to maintain muscle contractions while reducing the stimulating current to approximately 0.5-0.6 mA.
4 mL of the local anaesthetic mixture is injected at each injection site. Each 20 mL of the local anaesthetic mixture contains: 8mL lidocaine 2%, 8 mL lidocaine 2% with epinephrine 5µg/mL and 4 mL bupivacaine 0.5%.
- Conditions
- Reduce Pain After Appendectomy
- Being tested
- PVB, Placebo, GA, Anesthetic injections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVBOther
nerve stimulator-guided PVB will be performed at two levels
PlaceboOther
nerve stimulator-guided PVB containing placebo will be performed at two levels
GAOther
All patients will receive general anesthesia.
Anesthetic injectionsOther
4 mL of the local anesthetic mixture is injected at each injection site. Each 20 mL of the local anaesthetic mixture contains: 8mL lidocaine 2%, 8 mL lidocaine 2% with epinephrine 5µg/mL and 4 mL bupivacaine 0.5%.
| Study group | Role | What they receive |
|---|---|---|
| PVB group | Experimental | Patients will receive two PVB injections at levels T12-L1 and L1-L2 using anesthetic mixture Receives: Other: PVB; Other: GA; Other: Anesthetic injections |
| Placebo | Placebo comparator | Patients will receive two PVB injections containing placebo at levels T12-L1 and L1-L2 Receives: Other: Placebo; Other: GA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic consumption
The quantity of analgesics consumed will be recorded
Measured: 24 hours postoperatively
Secondary outcomes (1)
hemodynamic stability measured through mean arterial pressure (MAP).
Intraoperative hemodynamic stability measured through mean arterial pressure (MAP)
Measured: Approximately 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start1 Jun 2017
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reduce Pain After AppendectomyStudies 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
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makassed General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zoher Naja, Makassed General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03189693
- Sponsor's protocol ID
- 212006
- Status last verified
- Jan 2022
- First submitted
- 13 Jun 2017
- Last updated
- 18 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paravertebral Block for Postoperative Pain Management in Adult Patients Undergoing Appendectomy
- ClinicalTrials.gov ID
- NCT03189693
- Acronym / sponsor ID
- 212006
- Conditions
- Reduce Pain After Appendectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Makassed General HospitalUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 16 Jun 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.
Paravertebral Block (PVB) was shown to be a successful and useful technique of anesthesia and analgesia. Its effect was evident in thoracic and abdominal surgeries. In the setting of appendectomy, somatic PVB has been used for pediatric patients. It was shown to decrease opioid consumption and provide prolonged pain relief. Hence, it would be beneficial to examine the analgesic effect of PVB on appendectomy in adult patients.
Detailed description
Patients undergoing appendectomy will be randomly allocated into two equal groups using the sealed envelope technique. All patients will receive general anesthesia (GA). Patients in group I will receive two PVB injections at levels T12-L1 and L1-L2 using anesthetic mixture, while patients in Group II will receive placebo.
Paravertebral Block Technique Unilateral right side nerve stimulator-guided PVB is performed while patients are in the left lateral decubitis position. The appropriate levels for the PVB are determined by palpation of the spinous processes. An intervertebral line is drawn at the appropriate levels and the injection site is marked 2.5 cm lateral to the midline. After aseptic preparation of the skin, 1 mL 1% lidocaine is infiltrated at the injection sites. A 21-G nerve stimulation needle (Stimuplex; B. Braun, Melsungen, Germany) is advanced 1-2 cm perpendicularly to the skin using a nerve stimulating current of 2.5-5.0 mA, while closely watching for contractions of the abdominal muscles. The tip of the needle is adjusted to maintain muscle contractions while reducing the stimulating current to approximately 0.5-0.6 mA.
4 mL of the local anaesthetic mixture is injected at each injection site. Each 20 mL of the local anaesthetic mixture contains: 8mL lidocaine 2%, 8 mL lidocaine 2% with epinephrine 5µg/mL and 4 mL bupivacaine 0.5%.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVB group | Experimental | Other: PVB, Other: GA, Other: Anesthetic injectionsPatients will receive two PVB injections at levels T12-L1 and L1-L2 using anesthetic mixture |
| Placebo | Placebo comparator | Other: Placebo, Other: GAPatients will receive two PVB injections containing placebo at levels T12-L1 and L1-L2 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Older than 18 years
- Scheduled to undergo appendectomy
Key exclusion criteria (4 listed)
- cardiac disease,
- developmental delay,
- neurologic deficit,
- allergies to any of the drugs routinely used in anesthesia management.
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 |
|---|---|---|
| PVBnerve stimulator-guided PVB will be performed at two levels | Other | PVB group |
| Placebonerve stimulator-guided PVB containing placebo will be performed at two levels | Other | Placebo |
| GAAll patients will receive general anesthesia. | Other | PVB group, Placebo |
| Anesthetic injections4 mL of the local anesthetic mixture is injected at each injection site. Each 20 mL of the local anaesthetic mixture contains: 8mL lidocaine 2%, 8 mL lidocaine 2% with epinephrine 5µg/mL and 4 mL bupivacaine 0.5%. | Other | PVB group |
Primary outcome
Analgesic consumption
Time frame: 24 hours postoperatively
The quantity of analgesics consumed will be recorded
1 secondary outcome
hemodynamic stability measured through mean arterial pressure (MAP).
Time frame: Approximately 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PVB, GA and Anesthetic injections in people with Reduce Pain After Appendectomy, run by Makassed General Hospital at 1 site in Lebanon.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 18 Jan 2022. 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 Lebanon. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zoher Naja, MD (+9611636000 ext. 6941, zouhnaja@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesic consumption (time frame: 24 hours postoperatively). 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 18 Jan 2022.