Postoperative PainNCT03935412
The Analgesic Efficacy of Bilateral Erector Spinae Plane Block in Comparison With Intrathecal Morphine After Elective Cesarean Section
A study testing Erector Spinae Plane Block in people with Postoperative Pain, run by Fayoum University at 1 site in Egypt.
Trial summary
The aim of this study was to assess the analgesic efficacy of bilateral erector spinae plane block in comparison with intrathecal morphine after elective cesarean section under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Erector Spinae Plane Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Mar 2019to 5 Jul 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- American Society of Anesthesiologists physical status (ASA) class Ι, scheduled for elective cesarean section via a low transverse abdominal incision (Pfannenstiel) and receiving intrathecal anesthesia without sedation
Who cannot join
- included significant hepatic, renal or cardiovascular diseases, local infection, bleeding disorders, any contraindication to intrathecal anesthesia and parturient had a known allergy to the study drugs.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to assess the analgesic efficacy of bilateral erector spinae plane block in comparison with intrathecal morphine after elective cesarean section under spinal anesthesia.
Read the detailed description
140 parturient scheduled for elective cesarean section. We obtained a written informed consent for anesthesia from each patient after explaining to them the nature of study and possible complications. Parturient were eligible for enrollment if they met the following inclusion criteria: Parturient aged 18 - 40 years , with American Society of Anesthesiologists physical status (ASA) class Ι, scheduled for elective cesarean section via a low transverse abdominal incision (Pfannenstiel) and receiving intrathecal anesthesia without sedation. Exclusion criteria included significant hepatic, renal or cardiovascular diseases, local infection, bleeding disorders, any contraindication to intrathecal anesthesia and parturient had a known allergy to the study drugs.
Participants were randomly divided into two groups (ITM; intrathecal morphine and ESPB; erector spinae plane block groups, with 70 participants in each) as simple randomization by computer-generated random numbers that were placed in separate opaque envelopes opened by responsible anesthesiologist just before intrathecal block. The participants, the study investigators and the data collectors were not aware of group allocation till the study end. Those in the ITM group were given 100 mcg of preservative-free morphine in addition local anesthetic (hyperbaric bupivacaine 10 mg) intrathecally during spinal anesthesia. While participants in the ESPB group were given only local anesthetic (hyperbaric bupivacaine 10 mg) intrathecally.
Preoperative investigations including electrocardiogram (ECG), complete blood picture, renal function tests, liver function tests, and coagulation profile were done. All parturient were fast for 8 h preoperatively. Upon arrival to the operating room IV access was obtained (one peripheral venous cannula 18G) and standard monitoring including pulse oximetry, ECG and noninvasive blood pressure were placed. And 10 ml.kg-1 of Ringer lactate solution will be infused over 15 minutes as a preload. The responsible anesthesiologist then asked the parturient to turn into sitting position where the skin on the back sterilized and; Spinal anesthesia performed via a midline approach into the L4-5 interspaces using a 25 gauge Quincke spinal needle after giving 3 ml of lidocaine 2% as a subcutaneous infiltration. After confirming free CSF flow through the needle a 10mg of hyperbaric bupivacaine 0.5 % was slowly injected for those in the ESPB group; and for those in the ITM group intrathecal injection of 10mg of hyperbaric bupivacaine 0.5 % in addition to 100 mcg of preservative-free morphine. Then, the parturient immediately placed in the supine position with 15° left tilt, and an oxygen mask was applied at 2 l.min-1. After ensuring sufficient anesthesia level, the surgical procedure was done with continuous hemodynamics monitoring and recording. If the systolic blood pressure (SBP) decreased to 20% below the baseline or less than 90 mmHg, ephedrine 5 mg will be administered intravenously. Also, if HR will be less than 50 beats/ min, atropine sulfate 0.5 mg will be administered intravenously. Upon delivery of the fetus, ten units of oxytocin were given by IV infusion.
By the end of surgery parturient in the ESPB underwent bilateral ESPB at the level of T9 using a linear ultrasound (US) transducer (Phillips Saronno Italy) the transducer was placed vertically3cm lateral to the midline to visualize the muscles of the back, transverse process and the pleura in between the two transverse processes. After local infiltration of the needle insertion site with 2-3 ml of 2% lidocaine 22-G short bevel needle (spinocan, B.Braun melsungen AG, Germany) was inserted in cranial-caudal direction towards the transvers process using in plane technique until the needle cross all the muscles then interfascial injection of 20ml 0.5% bupivacaine was done after ensuring negative aspiration, the procedure was repeated following the same steps on the other side of the back. While participants in the ITM group underwent sham blocks; Sham blocks consisted of a non-invasive ultrasound scan, while a blunt needle was gently pressed on both sides. We instructed the participants to report any signs of local anesthetic toxicity throughout injection e.g. change in mental status, anxiety, oral numbness and ringing in ears. For all participants spinal level and numerical rating scale were assessed and recorded before the block. At the end of surgery, parturient were transferred to postoperative anesthesia care unit (PACU) with standard monitoring applied. Any intraoperative or postoperative nausea or vomiting was managed with 10 mg metoclopramide. All participants received 30 mg ketorolac intravenously with the time of ESPB or sham blocks. Participants were transferred to obstetrics ward after fulfilling the criteria of modified Aldrete scoring system.
- Conditions
- Postoperative Pain
- Being tested
- Erector Spinae Plane Block
- Keywords
- Erector spinae plane block, morphine, cesarean section, postoperative analgesia, spinal anesthesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockProcedure or surgery
Erector Spinae Plane Block
| Study group | Role | What they receive |
|---|---|---|
| ES Erector Spinae Plane Block | Active comparator | By the end of surgery parturient in the ESPB underwent bilateral ESPB at the level of T9 using a linear ultrasound (US) transducer (Phillips Saronno Italy) the transducer was placed vertically3cm lateral to the midline to visualize the muscles of the back, transverse process and the pleura in between the two transverse processes. After local infiltration of the needle insertion site with 2-3 ml of 2% lidocaine 22-G short bevel needle (spinocan, B.Braun melsungen AG, Germany) was inserted in cranial-caudal direction towards the transvers process using in plane technique until the needle cross all the muscles then interfascial injection of 20ml 0.5% bupivacaine was done after ensuring negative aspiration, the procedure was repeated following the same steps on the other side of the back. Receives: Procedure: Erector Spinae Plane Block |
| intrathecal morphine ITM | Sham comparator | participant in the ITM group intrathecal injection of 10mg of hyperbaric bupivacaine 0.5 % in addition to 100 mcg of preservative-free morphine. Then, the parturient immediately placed in the supine position with 15° left tilt, and an oxygen mask was applied at 2 l.min-1. After ensuring sufficient anesthesia level, the surgical procedure was done with continuous hemodynamics monitoring and recording. While participants in the ITM group underwent sham blocks; Sham blocks consisted of a non-invasive ultrasound scan, while a blunt needle was gently pressed on both sides. Receives: Procedure: Erector Spinae Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
the severity of pain: VAS
VAS
Measured: 8 hour
Secondary outcomes (8)
the total analgesic consumption
AMOUNT
Measured: 24 hour
the severity of pain: VAS
VAS
Measured: immediately in PACU
the severity of pain: VAS
VAS
Measured: 4 hours
the severity of pain: VAS
VAS
Measured: 12 hours
the severity of pain: VAS
VAS
Measured: 16 hours
the severity of pain: VAS
VAS
Measured: 24 hours
the time for the first analgesic request
time
Measured: 24 hours
Participants' satisfaction
postoperative
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 posted2 May 2019
- Study start5 Mar 2019
- Primary completion1 Jul 2019
- Study completion5 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Fayoum UniversityThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed hamed, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935412
- Sponsor's protocol ID
- R 125
- Status last verified
- Jul 2019
- First submitted
- 1 Mar 2019
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ueshima H, Otake H. Similarities Between the Retrolaminar and Erector Spinae Plane Blocks. Reg Anesth Pain Med. 2017 Jan/Feb;42(1):123-124. doi: 10.1097/AAP.0000000000000526. No abstract available.
PubMed 27997492Leung AY. Postoperative pain management in obstetric anesthesia--new challenges and solutions. J Clin Anesth. 2004 Feb;16(1):57-65. doi: 10.1016/j.jclinane.2003.02.012.
PubMed 14984863
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Efficacy of Bilateral Erector Spinae Plane Block in Comparison With Intrathecal Morphine After Elective Cesarean Section
- ClinicalTrials.gov ID
- NCT03935412
- Acronym / sponsor ID
- R 125
- Conditions
- Postoperative Pain
- Keywords
- Erector spinae plane block, morphine, cesarean section, postoperative analgesia, spinal anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 5 Mar 2019 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 5 Jul 2019 (actual)
- First posted
- 2 May 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.
The aim of this study was to assess the analgesic efficacy of bilateral erector spinae plane block in comparison with intrathecal morphine after elective cesarean section under spinal anesthesia.
Detailed description
140 parturient scheduled for elective cesarean section. We obtained a written informed consent for anesthesia from each patient after explaining to them the nature of study and possible complications. Parturient were eligible for enrollment if they met the following inclusion criteria: Parturient aged 18 - 40 years , with American Society of Anesthesiologists physical status (ASA) class Ι, scheduled for elective cesarean section via a low transverse abdominal incision (Pfannenstiel) and receiving intrathecal anesthesia without sedation. Exclusion criteria included significant hepatic, renal or cardiovascular diseases, local infection, bleeding disorders, any contraindication to intrathecal anesthesia and parturient had a known allergy to the study drugs.
Participants were randomly divided into two groups (ITM; intrathecal morphine and ESPB; erector spinae plane block groups, with 70 participants in each) as simple randomization by computer-generated random numbers that were placed in separate opaque envelopes opened by responsible anesthesiologist just before intrathecal block. The participants, the study investigators and the data collectors were not aware of group allocation till the study end. Those in the ITM group were given 100 mcg of preservative-free morphine in addition local anesthetic (hyperbaric bupivacaine 10 mg) intrathecally during spinal anesthesia. While participants in the ESPB group were given only local anesthetic (hyperbaric bupivacaine 10 mg) intrathecally.
Preoperative investigations including electrocardiogram (ECG), complete blood picture, renal function tests, liver function tests, and coagulation profile were done. All parturient were fast for 8 h preoperatively. Upon arrival to the operating room IV access was obtained (one peripheral venous cannula 18G) and standard monitoring including pulse oximetry, ECG and noninvasive blood pressure were placed. And 10 ml.kg-1 of Ringer lactate solution will be infused over 15 minutes as a preload. The responsible anesthesiologist then asked the parturient to turn into sitting position where the skin on the back sterilized and; Spinal anesthesia performed via a midline approach into the L4-5 interspaces using a 25 gauge Quincke spinal needle after giving 3 ml of lidocaine 2% as a subcutaneous infiltration. After confirming free CSF flow through the needle a 10mg of hyperbaric bupivacaine 0.5 % was slowly injected for those in the ESPB group; and for those in the ITM group intrathecal injection of 10mg of hyperbaric bupivacaine 0.5 % in addition to 100 mcg of preservative-free morphine. Then, the parturient immediately placed in the supine position with 15° left tilt, and an oxygen mask was applied at 2 l.min-1. After ensuring sufficient anesthesia level, the surgical procedure was done with continuous hemodynamics monitoring and recording. If the systolic blood pressure (SBP) decreased to 20% below the baseline or less than 90 mmHg, ephedrine 5 mg will be administered intravenously. Also, if HR will be less than 50 beats/ min, atropine sulfate 0.5 mg will be administered intravenously. Upon delivery of the fetus, ten units of oxytocin were given by IV infusion.
By the end of surgery parturient in the ESPB underwent bilateral ESPB at the level of T9 using a linear ultrasound (US) transducer (Phillips Saronno Italy) the transducer was placed vertically3cm lateral to the midline to visualize the muscles of the back, transverse process and the pleura in between the two transverse processes. After local infiltration of the needle insertion site with 2-3 ml of 2% lidocaine 22-G short bevel needle (spinocan, B.Braun melsungen AG, Germany) was inserted in cranial-caudal direction towards the transvers process using in plane technique until the needle cross all the muscles then interfascial injection of 20ml 0.5% bupivacaine was done after ensuring negative aspiration, the procedure was repeated following the same steps on the other side of the back. While participants in the ITM group underwent sham blocks; Sham blocks consisted of a non-invasive ultrasound scan, while a blunt needle was gently pressed on both sides. We instructed the participants to report any signs of local anesthetic toxicity throughout injection e.g. change in mental status, anxiety, oral numbness and ringing in ears. For all participants spinal level and numerical rating scale were assessed and recorded before the block. At the end of surgery, parturient were transferred to postoperative anesthesia care unit (PACU) with standard monitoring applied. Any intraoperative or postoperative nausea or vomiting was managed with 10 mg metoclopramide. All participants received 30 mg ketorolac intravenously with the time of ESPB or sham blocks. Participants were transferred to obstetrics ward after fulfilling the criteria of modified Aldrete scoring system.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ES Erector Spinae Plane Block | Active comparator | Procedure: Erector Spinae Plane BlockBy the end of surgery parturient in the ESPB underwent bilateral ESPB at the level of T9 using a linear ultrasound (US) transducer (Phillips Saronno Italy) the transducer was placed vertically3cm lateral to the midline to visualize the muscles of the back, transverse process and the pleura in between the two transverse processes. After local infiltration of the needle insertion site with 2-3 ml of 2% lidocaine 22-G short bevel needle (spinocan, B.Braun melsungen AG, Germany) was inserted in cranial-caudal direction towards the transvers process using in plane technique until the needle cross all the muscles then interfascial injection of 20ml 0.5% bupivacaine was done after ensuring negative aspiration, the procedure was repeated following the same steps on the other side of the back. |
| intrathecal morphine ITM | Sham comparator | Procedure: Erector Spinae Plane Blockparticipant in the ITM group intrathecal injection of 10mg of hyperbaric bupivacaine 0.5 % in addition to 100 mcg of preservative-free morphine. Then, the parturient immediately placed in the supine position with 15° left tilt, and an oxygen mask was applied at 2 l.min-1. After ensuring sufficient anesthesia level, the surgical procedure was done with continuous hemodynamics monitoring and recording. While participants in the ITM group underwent sham blocks; Sham blocks consisted of a non-invasive ultrasound scan, while a blunt needle was gently pressed on both sides. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists physical status (ASA) class Ι, scheduled for elective cesarean section via a low transverse abdominal incision (Pfannenstiel) and receiving intrathecal anesthesia without sedation
Key exclusion criteria (1 listed)
- included significant hepatic, renal or cardiovascular diseases, local infection, bleeding disorders, any contraindication to intrathecal anesthesia and parturient had a known allergy to the study drugs.
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 |
|---|---|---|
| Erector Spinae Plane BlockErector Spinae Plane Block | Procedure or surgery | ES Erector Spinae Plane Block, intrathecal morphine ITM |
Primary outcome
the severity of pain: VAS
Time frame: 8 hour
VAS
8 secondary outcomes
the total analgesic consumption
Time frame: 24 hour
the severity of pain: VAS
Time frame: immediately in PACU
the severity of pain: VAS
Time frame: 4 hours
the severity of pain: VAS
Time frame: 12 hours
the severity of pain: VAS
Time frame: 16 hours
the severity of pain: VAS
Time frame: 24 hours
the time for the first analgesic request
Time frame: 24 hours
Participants' satisfaction
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 23 Jul 2019.
- Background: PubMed 27997492Ueshima H, Otake H. Similarities Between the Retrolaminar and Erector Spinae Plane Blocks. Reg Anesth Pain Med. 2017 Jan/Feb;42(1):123-124. doi: 10.1097/AAP.0000000000000526. No abstract available.
- Results publication: PubMed 14984863Leung AY. Postoperative pain management in obstetric anesthesia--new challenges and solutions. J Clin Anesth. 2004 Feb;16(1):57-65. doi: 10.1016/j.jclinane.2003.02.012.
Related trials for Postoperative Pain
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.
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 Erector Spinae Plane Block in people with Postoperative Pain, run by Fayoum 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 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 23 Jul 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. 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?
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?
the severity of pain: VAS (time frame: 8 hour). 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 NCT03935412, which also lists 2 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 23 Jul 2019.