IncidencePhase 4NCT03806673
Is There a Relation Between Unilateral Epidural Block and Repeated Epidural Anesthesia?
A Phase 4 study testing marcaine in people with Incidence and Unilateral, run by Ain Shams University at 1 site in Egypt.
Trial summary
epidural block is today the most common method of pain relief during labor. With increased use of epidural analgesia, many women are found in the second or third pregnancy and require repeated epidural analgesia. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Incidence, Unilateral, Epidural Block
- What is being tested?
- marcaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Feb 2018to 11 Sep 2018
- Phase
- Phase 4
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy ASA II female patients,
- 20-40 years of age,
- scheduled for normal vaginal delivery.
Who cannot join
- - Any physical reason for difficult epidural performance e.g.: morbid obesity, or scoliosis,
- Severe hypertension,
- Congestive heart failure,
- Coagulopathy,
- Significant hepatic or renal disease,
- Or withdrawal of consent.
Trial locations and contacts
1 site in 1 country.
About this study
epidural block is today the most common method of pain relief during labor. With increased use of epidural analgesia, many women are found in the second or third pregnancy and require repeated epidural analgesia. But there was a higher incidence of unilateral blockade among women receiving their repeated epidural which causes patient unsatisfaction.
Objectives: Examination of the performance and outcome of women receiving their first versus repeated epidural block.
Patients and methods: The study included 140 American Society of Anesthesiologists (ASA) Physical Status II patients (age range 20 to 40 years) and scheduled for normal vaginal delivery. The patients were divided randomly into two equal groups. Group (A) in which 70 women primipara subjected to their first epidural block while group (B) in which 70 women multipara subjected to their repeated epidural block. For each patient, the following data were collected: demographic data, details of labor (gestation, cervical dilatation), visual analogue scale (VAS) before the epidural and 30 minutes after injection of local anesthetic and incidence of unilateral block.
Read the detailed description
This study was performed after obtaining approval from the ethical committee of the Ain Shams University. Sample of 140 healthy ASA II female patients, 20-40 years of age, scheduled for normal vaginal delivery. Patients were randomly allocated by computer-generated random number list into two study groups of 70 patients each.
Group (A) in which 70 primipara women subjected to their first epidural block while group (B) in which 70 multipara women subjected to their repeated epidural block. The study was carried out between January 2018 and March 2018.
Patients were excluded for:
- Any physical reason for difficult epidural performance e.g.: morbid obesity, or scoliosis,
- Severe hypertension,
- Congestive heart failure,
- Coagulopathy,
- Significant hepatic or renal disease,
- Or withdrawal of consent. All patients in this study were subjected to a detailed pre-anesthetic evaluation. All basic investigations according to the hospital protocol (e.g. serum hemoglobin, platelet count, coagulation profile) were checked.
The patient's demographic data, details of labor (gestation, cervical dilatation), details of epidural insertion were recorded by the anesthetist performing the epidural.
The patient was asked to mark a visual analogue scale (VAS) (figure 1) before the epidural and 30 minutes after injection of local anesthetic. Also incidence of unilateral epidural block is reported 30 minutes after injection of local anesthetic.
Figure (1): Visual analog scale 2.2 Anesthetic technique On arrival to operation room; 18 g cannula was inserted then 500 ml of Ringer solution was infused while performing the epidural.
Basic monitors including automatic blood pressure measurements, five lead ECG monitor, and finger pulse oximetry were applied to all patients.
A standard procedure was followed for epidural insertion and establishment of block. With the patient in the sitting position the midline approach was used using 16-g Tuohy needle and the epidural space was identified by loss of resistance to air, as is our routine practice.
Once the epidural space was reached, Bupivacaine 0.25% plain, was given in three 5 ml increments at five-minute intervals, the first administered through the needle while the patient is in sitting position, and then through the catheter with the patient in supine position.
Multi-orifice catheters were inserted and fixed to a standard 4 cm extra to the distance between the skin and epidural space. At the time of insertion of the catheter the patient was asked to report any pain or tingling experienced.
The operator recorded the ease of insertion of the catheter (difficult or easy) and the occurrence of blood in needle or catheter. Epidurals were performed by the same anesthetists.
At 30 min after injection of bupivacaine, the second VAS was completed and the level of blockade checked by cold sensation test. If an inadequate level was noted (less than T10), the pain score remained high or increased, or the patient complained of poor pain relief she was asked to describe the site and type of pain experienced.
A unilateral block was defined as the description by the patient of worse pain on one side than the other, or pain on one side only, combined with either a 30-min pain score minimally changed or increased from time zero or a low level of blockade on the painful side, or both. If unilateral or inadequate block occurred the catheter was withdrawn 0.5-1 cm and a further 5 ml bupivacaine 0.25% was administered with the patient lying on the unblocked side. If the block was still inadequate, epidural fentanyl 50 microgram was given and if still inadequate the catheter was removed and a second epidural catheter inserted in another interspace.
The number of repeat injections of bupivacaine and length of time between epidural insertion and delivery were noted, as well details of previous epidurals in the multiparous women.
Sample size estimation:
To show a difference in the incidence of unilateral block between the two groups with p-value < 0.05 and power 80%, we needed at least 60 patients per group.
Statistical analysis:
Analysis of data was done by IBM computer using SPSS (statistical program for social science, version 16) as follows:
- Description of quantitative variables as mean ± SD.
- Description of quantitative variables as number and percentage. Statistical analysis was performed using statistical tests included Student's t-test, Chi square test and table analysis. P value <0.05 is considered significant.
- Conditions
- Incidence, Unilateral, Epidural Block
- Being tested
- marcaine
- Keywords
- unilateral, ,, epidural block, repeated epidural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
marcaineDrug
epidural block
| Study group | Role | What they receive |
|---|---|---|
| primipara | Active comparator | primipara subjected to their first epidural block Receives: Drug: marcaine |
| multipara | Active comparator | multipara subjected to their repeated epidural block. Receives: Drug: marcaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensation
by cold skin test
Measured: 30 minutes after injection of local anesthetic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start5 Feb 2018
- Primary completion1 Sep 2018
- Study completion11 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IncidenceStudies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double blinded randomized
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RAMY AHMED, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806673
- Sponsor's protocol ID
- Ain Shams Un
- Status last verified
- Jan 2019
- First submitted
- 12 Jan 2019
- Last updated
- 16 Jan 2019
- Results posted
- No
- 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 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There a Relation Between Unilateral Epidural Block and Repeated Epidural Anesthesia?
- ClinicalTrials.gov ID
- NCT03806673
- Acronym / sponsor ID
- Ain Shams Un
- Conditions
- Incidence, Unilateral, Epidural Block
- Keywords
- unilateral, ,, epidural block, repeated epidural
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 11 Sep 2018 (actual)
- First posted
- 16 Jan 2019 (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.
epidural block is today the most common method of pain relief during labor. With increased use of epidural analgesia, many women are found in the second or third pregnancy and require repeated epidural analgesia. But there was a higher incidence of unilateral blockade among women receiving their repeated epidural which causes patient unsatisfaction.
Objectives: Examination of the performance and outcome of women receiving their first versus repeated epidural block.
Patients and methods: The study included 140 American Society of Anesthesiologists (ASA) Physical Status II patients (age range 20 to 40 years) and scheduled for normal vaginal delivery. The patients were divided randomly into two equal groups. Group (A) in which 70 women primipara subjected to their first epidural block while group (B) in which 70 women multipara subjected to their repeated epidural block. For each patient, the following data were collected: demographic data, details of labor (gestation, cervical dilatation), visual analogue scale (VAS) before the epidural and 30 minutes after injection of local anesthetic and incidence of unilateral block.
Detailed description
This study was performed after obtaining approval from the ethical committee of the Ain Shams University. Sample of 140 healthy ASA II female patients, 20-40 years of age, scheduled for normal vaginal delivery. Patients were randomly allocated by computer-generated random number list into two study groups of 70 patients each.
Group (A) in which 70 primipara women subjected to their first epidural block while group (B) in which 70 multipara women subjected to their repeated epidural block. The study was carried out between January 2018 and March 2018.
Patients were excluded for:
- Any physical reason for difficult epidural performance e.g.: morbid obesity, or scoliosis,
- Severe hypertension,
- Congestive heart failure,
- Coagulopathy,
- Significant hepatic or renal disease,
- Or withdrawal of consent. All patients in this study were subjected to a detailed pre-anesthetic evaluation. All basic investigations according to the hospital protocol (e.g. serum hemoglobin, platelet count, coagulation profile) were checked.
The patient's demographic data, details of labor (gestation, cervical dilatation), details of epidural insertion were recorded by the anesthetist performing the epidural.
The patient was asked to mark a visual analogue scale (VAS) (figure 1) before the epidural and 30 minutes after injection of local anesthetic. Also incidence of unilateral epidural block is reported 30 minutes after injection of local anesthetic.
Figure (1): Visual analog scale 2.2 Anesthetic technique On arrival to operation room; 18 g cannula was inserted then 500 ml of Ringer solution was infused while performing the epidural.
Basic monitors including automatic blood pressure measurements, five lead ECG monitor, and finger pulse oximetry were applied to all patients.
A standard procedure was followed for epidural insertion and establishment of block. With the patient in the sitting position the midline approach was used using 16-g Tuohy needle and the epidural space was identified by loss of resistance to air, as is our routine practice.
Once the epidural space was reached, Bupivacaine 0.25% plain, was given in three 5 ml increments at five-minute intervals, the first administered through the needle while the patient is in sitting position, and then through the catheter with the patient in supine position.
Multi-orifice catheters were inserted and fixed to a standard 4 cm extra to the distance between the skin and epidural space. At the time of insertion of the catheter the patient was asked to report any pain or tingling experienced.
The operator recorded the ease of insertion of the catheter (difficult or easy) and the occurrence of blood in needle or catheter. Epidurals were performed by the same anesthetists.
At 30 min after injection of bupivacaine, the second VAS was completed and the level of blockade checked by cold sensation test. If an inadequate level was noted (less than T10), the pain score remained high or increased, or the patient complained of poor pain relief she was asked to describe the site and type of pain experienced.
A unilateral block was defined as the description by the patient of worse pain on one side than the other, or pain on one side only, combined with either a 30-min pain score minimally changed or increased from time zero or a low level of blockade on the painful side, or both. If unilateral or inadequate block occurred the catheter was withdrawn 0.5-1 cm and a further 5 ml bupivacaine 0.25% was administered with the patient lying on the unblocked side. If the block was still inadequate, epidural fentanyl 50 microgram was given and if still inadequate the catheter was removed and a second epidural catheter inserted in another interspace.
The number of repeat injections of bupivacaine and length of time between epidural insertion and delivery were noted, as well details of previous epidurals in the multiparous women.
Sample size estimation:
To show a difference in the incidence of unilateral block between the two groups with p-value < 0.05 and power 80%, we needed at least 60 patients per group.
Statistical analysis:
Analysis of data was done by IBM computer using SPSS (statistical program for social science, version 16) as follows:
- Description of quantitative variables as mean ± SD.
- Description of quantitative variables as number and percentage. Statistical analysis was performed using statistical tests included Student's t-test, Chi square test and table analysis. P value <0.05 is considered significant.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- double blinded randomized
| Arm | Type | Receives |
|---|---|---|
| primipara | Active comparator | Drug: marcaineprimipara subjected to their first epidural block |
| multipara | Active comparator | Drug: marcainemultipara subjected to their repeated epidural block. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy ASA II female patients,
Key exclusion criteria (6 listed)
- - Any physical reason for difficult epidural performance e.g.: morbid obesity, or scoliosis,
- Severe hypertension,
- Congestive heart failure,
- Coagulopathy,
- Significant hepatic or renal disease,
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 |
|---|---|---|
| marcaineepidural block | Drug | multipara, primipara |
Primary outcome
sensation
Time frame: 30 minutes after injection of local anesthetic
by cold skin test
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 16 Jan 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing marcaine in people with Incidence and Unilateral, run by Ain Shams University at 1 site in Egypt.
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 3 inclusion and 6 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 16 Jan 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 Egypt. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
sensation (time frame: 30 minutes after injection of local anesthetic). 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 16 Jan 2019; AzTrials last refreshed its copy on 29 Oct 2026.