Anesthesia, SpinalNCT04050059
Comparison of Two Analgesic Pretreatment Techniques Before Spinal Needle Insertion for Pain Reduction and Maternal Satisfaction Level Assessment in Women Undergoing LSCS.
A study testing EMLA cream and 2% lidocaine in people with Anesthesia, Spinal and Pain, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Nowadays lower segment cesarean sections are preferably carried out under regional anesthesia due to multiple advantages. Local infiltration of lidocaine or any other anesthetic is used before lumber puncture in many centers to reduce needle stick pain. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Spinal, Pain, Pregnancy
- What is being tested?
- EMLA cream and 2% lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 sitePakistan
- Study dates
- 13 Nov 2019to 15 Dec 2019
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All adult women undergoing elective LSCS under spinal anesthesia
Who cannot join
- BMI of more than 35 kg/m2
- Contraindication to spinal anesthesia
- Spinal deformity
- Refusal of regional anesthesia
- Patients with a history of back surgery
- confirmed allergy to local anesthetics
- More than three attempts of needle insertion for inducing spinal anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Analgesic Pretreatment Techniques (2% Lidocaine Infiltration vs. EMLA Cream Application) Before Spinal Needle Insertion for Pain Reduction and Maternal Satisfaction Level Assessment in Women Undergoing LSCS. A Prospective Randomized Control Trial
Nowadays lower segment cesarean sections are preferably carried out under regional anesthesia due to multiple advantages.
Local infiltration of lidocaine or any other anesthetic is used before lumber puncture in many centers to reduce needle stick pain.
EMLA (eutectic mixture of local anesthetic) cream is the combination of lidocaine and prilocaine which have been effectively used in few studies to reduce needle prick pain.
We would like to see which analgesic pretreatment is superior in terms of reducing pain of spinal needle insertion and have better maternal satisfaction levels.
Read the detailed description
OBJECTIVES: To compare the pain reduction and maternal satisfaction levels of two analgesic pretreatment modalities on pain reduction of spinal needle insertion i.e. 2% lidocaine infiltration and EMLA in patients undergoing elective LSCS.
Hypothesis: Analgesic pre-treatment with EMLA is superior to local skin infiltration with lidocaine
- Conditions
- Anesthesia, Spinal, Pain, Pregnancy, Cesarean Section
- Being tested
- EMLA cream, 2% lidocaine
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMLA creamDrug
EMLA cream (5g tube Aspen pharma trading limited) will be applied topically in dose of 2.5 grams (half tube of cream) and area will be covered with tegaderm dressing. Application of EMLA will at least stay for 30 minutes before spinal needle insertion
2% lidocaineDrug
In 2% lidocaine group infiltration (Xylocaine 2% Barrett Hodgson Pakistan Pvt limited), skin and subcutaneous tissue will be infiltrated with 3 ml of 2% lidocaine (dose of 60 mg) before spinal needle insertion
| Study group | Role | What they receive |
|---|---|---|
| 2% Lidocaine group | Active comparator | In 2% lidocaine group infiltration (Xylocaine 2% Barrett Hodgson Pakistan Pvt limited) skin and subcutaneous tissue will be infiltrated with 3 ml of 2% lidocaine (dose of 60 mg) before spinal anesthesia induction. Receives: Drug: 2% lidocaine |
| EMLA cream group | Active comparator | In EMLA (Eutectic Mixture of Local Anesthesia- lidocaine 2.5% and prilocaine 2.5%) cream group, EMLA cream (5g tube Aspen pharma trading limited) will be applied topically in dose of 2.5 grams (half tube of cream) and area will be covered with tegaderm dressing. Application of EMLA will at least stay for 30 minutes before spinal needle insertion Receives: Drug: EMLA cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score (Subjective)
Visual Analogue Scale pain Score in cm
Measured: After 10 minutes (right after spinal anesthesia procedure is complete)
Pain Score (Objective)
Objective scoring:
1= No pain 2 = Mild flinch 3 = Wince 4= Yelp 5= Pulled away
Measured: During spinal anesthesia procedure
Maternal Satisfaction
Maternal Satisfaction Score (end of spinal anesthesia):
Very Satisfied Satisfied No comments Unsatisfied Very Unsatisfied
Measured: After 10 minutes (right after spinal anesthesia procedure is complete)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start13 Nov 2019
- Primary completion1 Dec 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, SpinalStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Malika Hameed, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04050059
- Sponsor's protocol ID
- 2019-1791-4956
- Status last verified
- Apr 2020
- First submitted
- 4 Aug 2019
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Koscielniak-Nielsen Z, Hesselbjerg L, Brushoj J, Jensen MB, Pedersen HS. EMLA patch for spinal puncture. A comparison of EMLA patch with lignocaine infiltration and placebo patch. Anaesthesia. 1998 Dec;53(12):1218-22. doi: 10.1046/j.1365-2044.1998.00608.x.
PubMed 10193230Sharma SK, Gajraj NM, Sidawi JE, Lowe K. EMLA cream effectively reduces the pain of spinal needle insertion. Reg Anesth. 1996 Nov-Dec;21(6):561-4.
PubMed 8956393Wenk M, Massoth C, Weidlich S, Pöpping D M, Gurlit S, et al. Effects of local skin anaesthesia on pain during lumbar puncture. J Anaesthesiol Crit Care. 2017;1 (1):1-5
Juarez Gimenez JC, Oliveras M, Hidalgo E, Cabanas MJ, Barroso C, Moraga FA, Gallego S, de Toledo JS. Anesthetic efficacy of eutectic prilocaine-lidocaine cream in pediatric oncology patients undergoing lumbar puncture. Ann Pharmacother. 1996 Nov;30(11):1235-7. doi: 10.1177/106002809603001104.
PubMed 8913402
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Analgesic Pretreatment Techniques (2% Lidocaine Infiltration vs. EMLA Cream Application) Before Spinal Needle Insertion for Pain Reduction and Maternal Satisfaction Level Assessment in Women Undergoing LSCS. A Prospective Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04050059
- Acronym / sponsor ID
- 2019-1791-4956
- Conditions
- Anesthesia, Spinal, Pain, Pregnancy, Cesarean Section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 8 Aug 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.
Nowadays lower segment cesarean sections are preferably carried out under regional anesthesia due to multiple advantages.
Local infiltration of lidocaine or any other anesthetic is used before lumber puncture in many centers to reduce needle stick pain.
EMLA (eutectic mixture of local anesthetic) cream is the combination of lidocaine and prilocaine which have been effectively used in few studies to reduce needle prick pain.
We would like to see which analgesic pretreatment is superior in terms of reducing pain of spinal needle insertion and have better maternal satisfaction levels.
Detailed description
OBJECTIVES: To compare the pain reduction and maternal satisfaction levels of two analgesic pretreatment modalities on pain reduction of spinal needle insertion i.e. 2% lidocaine infiltration and EMLA in patients undergoing elective LSCS.
Hypothesis: Analgesic pre-treatment with EMLA is superior to local skin infiltration with lidocaine
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2% Lidocaine group | Active comparator | Drug: 2% lidocaineIn 2% lidocaine group infiltration (Xylocaine 2% Barrett Hodgson Pakistan Pvt limited) skin and subcutaneous tissue will be infiltrated with 3 ml of 2% lidocaine (dose of 60 mg) before spinal anesthesia induction. |
| EMLA cream group | Active comparator | Drug: EMLA creamIn EMLA (Eutectic Mixture of Local Anesthesia- lidocaine 2.5% and prilocaine 2.5%) cream group, EMLA cream (5g tube Aspen pharma trading limited) will be applied topically in dose of 2.5 grams (half tube of cream) and area will be covered with tegaderm dressing. Application of EMLA will at least stay for 30 minutes before spinal needle insertion |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All adult women undergoing elective LSCS under spinal anesthesia
Key exclusion criteria (7 listed)
- BMI of more than 35 kg/m2
- Contraindication to spinal anesthesia
- Spinal deformity
- Refusal of regional anesthesia
- Patients with a history of back surgery
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 |
|---|---|---|
| EMLA creamEMLA cream (5g tube Aspen pharma trading limited) will be applied topically in dose of 2.5 grams (half tube of cream) and area will be covered with tegaderm dressing. Application of EMLA will at least stay for 30 minutes before spinal needle insertion | Drug | EMLA cream group |
| 2% lidocaineIn 2% lidocaine group infiltration (Xylocaine 2% Barrett Hodgson Pakistan Pvt limited), skin and subcutaneous tissue will be infiltrated with 3 ml of 2% lidocaine (dose of 60 mg) before spinal needle insertion | Drug | 2% Lidocaine group |
Primary outcome
Pain Score (Subjective)
Time frame: After 10 minutes (right after spinal anesthesia procedure is complete)
Visual Analogue Scale pain Score in cm
Pain Score (Objective)
Time frame: During spinal anesthesia procedure
Objective scoring: 1= No pain 2 = Mild flinch 3 = Wince 4= Yelp 5= Pulled away
Maternal Satisfaction
Time frame: After 10 minutes (right after spinal anesthesia procedure is complete)
Maternal Satisfaction Score (end of spinal anesthesia): Very Satisfied Satisfied No comments Unsatisfied Very Unsatisfied
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 8 Apr 2020.
- Background: PubMed 10193230Koscielniak-Nielsen Z, Hesselbjerg L, Brushoj J, Jensen MB, Pedersen HS. EMLA patch for spinal puncture. A comparison of EMLA patch with lignocaine infiltration and placebo patch. Anaesthesia. 1998 Dec;53(12):1218-22. doi: 10.1046/j.1365-2044.1998.00608.x.
- Background: PubMed 8956393Sharma SK, Gajraj NM, Sidawi JE, Lowe K. EMLA cream effectively reduces the pain of spinal needle insertion. Reg Anesth. 1996 Nov-Dec;21(6):561-4.
- BackgroundWenk M, Massoth C, Weidlich S, Pöpping D M, Gurlit S, et al. Effects of local skin anaesthesia on pain during lumbar puncture. J Anaesthesiol Crit Care. 2017;1 (1):1-5
- Background: PubMed 8913402Juarez Gimenez JC, Oliveras M, Hidalgo E, Cabanas MJ, Barroso C, Moraga FA, Gallego S, de Toledo JS. Anesthetic efficacy of eutectic prilocaine-lidocaine cream in pediatric oncology patients undergoing lumbar puncture. Ann Pharmacother. 1996 Nov;30(11):1235-7. doi: 10.1177/106002809603001104.
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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 study testing EMLA cream and 2% lidocaine in people with Anesthesia, Spinal and Pain, run by Aga Khan University at 1 site in Pakistan.
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 7 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 8 Apr 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 Pakistan. 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.
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 Score (Subjective) (time frame: After 10 minutes (right after spinal anesthesia procedure is complete)). 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 NCT04050059, which also lists 4 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 8 Apr 2020.