Iliohypogastric and Ilioinguinal Nerve Block for Acute and Chronic Pain in Cesarean SectionNCT04526015
Iliohypogastric and Ilioinguinal Nerve Block for Acute and Chronic Pain Relief After Cesarean Section.
A study testing Iliohypogastric and ilioinguinal nerve block in people with Iliohypogastric and Ilioinguinal Nerve Block for Acute and Chronic Pain in Cesarean Section, run by Tanta University at 1 site in Egypt.
Trial summary
The increase in CS in recent years makes even a small prevalence of persistent pain after CS a significant burden, both financially and in terms of quality of life, for a large number of otherwise healthy young women. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Iliohypogastric and Ilioinguinal Nerve Block for Acute and Chronic Pain in Cesarean Section
- What is being tested?
- Iliohypogastric and ilioinguinal nerve block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Sep 2020to 1 Aug 2021
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant female.less than 40 years .
- ASA l,ll full term scheduled for elective cesarean section
Who cannot join
- patient refusal
- Emergency section
- More than I prior section
- Current pain disorder
- Allergy to local anesthetic
- Coagulopathy
- Major cardiac,renal, hepatic disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Analgesic Effect of Iliohypogastric and Ilioinguinal Nerve Block for Acute and Chronic Pain Relief After Cesarean Section Delivery.Randomized Controlled Study Post
The increase in CS in recent years makes even a small prevalence of persistent pain after CS a significant burden, both financially and in terms of quality of life, for a large number of otherwise healthy young women. Persistent pain after CS has been shown to be associated with postpartum depression, interferes with daily activities, and causes sleep disturbances, all of which negatively and directly impact the mother. As a result, the care of the baby by the mother is affected negatively.
To adequately control postoperative pain, healthcare providers use a one-size-fits-all multimodal analgesic approach and sensible opioid prescription with monitoring to prevent addiction. The challenge is in tailoring this approach to the outliers who may be opioid tolerant or opioid-sensitive. However, the severity and duration of postoperative pain and its management may be predictive of developing persistent pain at two to 12 months or later.
Previous studies revealed different outcomes regarding the analgesic efficacy of II-IH nerve block for post caesarean pain, inguinal repair and surgery involving the female genital tract. Moreover, exploring the efficacy of II-IH nerve block could help to tackle sever postoperative pain after cesarean delivery particularly in settings where there is shortage of epidural kit supply and availability of strong opioids for pain management. We aimed to assess the analgesic efficacy of bilateral ilioinguinal and iliohypogastric nerve block for planned caesareans delivery under spinal anaesthesia and evaluate the incidence of persistent pain with transition from acute to chronic pain.
Read the detailed description
All patients will be assessed preoperatively by history taking, physical examination, and laboratory evaluation. On arrival of the patients to the operative room, electrocardiography, non-invasive blood pressure and pulse oximetry will be applied.
The patients will be positioned in sitting position to give the spinal anesthesia at L3-L4/L2-L3 intervertebral level in the midline approach. After local infiltration of skin and subcutaneous tissue with 2% lignocaine, 25 G B-braun spinal needle will be used to administer subarachnoid block (SAB) with 2.5 ml of hyperbaric bupivacaine (5%) and 20 µg of fentanyl after confirmation of free flow of cerebrospinal fluid (CSF) at the hub of the needle. Patients will be coloaded with 10-12 ml/kg (over the period of 15 min) of Ringer's Lactate (RL) solution at the time of SAB. Thereafter, patients will be placed in supine position with wedge under the right hip.
64 Patients were randomly allocated into two equal groups (each 32 patients):
- Group B (IL/IH group): Each patient will receive spinal anesthesia plus bilateral ultrasound-guided IL/IH nerve block. The abdomen will be scanned through anterior superior iliac spine (ASIS)-umbilicus line. Ilioinguinal nerve can be visualized between the internal oblique and transverse or external oblique muscles and within 1 to 3 cm from the ASIS. The iliohypogastric nerve lies immediately adjacent. After negative aspiration (to exclude intravascular injection), 10 mL of 0.25% bupivacaine will be injected. The same technique will be performed on the other side
- Group C (Controlled group): Each patient will receive spinal anesthesia alone with no block.
Postoperative Analgesia Protocol
All patients will be given a standardized patient controlled intravenous analgesia (PCIA) regimen. The disposable PCIA device (Coopdech Syrinjector PCA set; Daiken Medical) contained 30 mg morphine in 45 ml saline. Patients will be instructed on how to use the PCIA device, which was set with a bolus of 2 mg morphine and a minimum interval of 30 min. If the analgesic effect was not satisfactory, complementary use of intravenous morphine will be applied.
Assessment of Acute Postoperative Pain
At 24 hours after surgery, pain intensity will be recorded on a 10-point verbal pain rating scale ranging from 0 to 10 (VPRS; 0 = no pain to 10 = worst pain imaginable), at rest (VPRS-R) and while moving into the sitting position (VPRS-S). Pain will be considered none, mild, moderate, or severe if scored 0, 1 to 3, 4 to 6, or 7 to 10, respectively.
Assessment of Persistent Postoperative Pain (3 and 6 Months) The Short-Form McGill Pain Questionnaire-Revised (SFMPQ- 2) was designed specifically and validated to assess both neuropathic and non-neuropathic aspects of chronic pain.
Women will report their average and worst pain the week prior to and at the time of the telephone interview using a previously developed scripted telephone interview. Persistent pain will be defined as new onset of pain related to the CS, located around the scar or in the abdomen, and still present at 8 weeks. Chronic pain will be defined if same symptoms were still present at 3 and 6 months.
Measurements The following parameters will be recorded by an anesthesia resident not included in the study and blinded to its groups: -
- Demographic data (Age in month, body mass index, and ASA class)
- Total consumption of analgesia (mg/kg) in first day postoperatively. (Primary outcome)
- The time to the first rescue analgesic request. (Secondary outcome) The postoperative pain score (NRS pain score). Assessment of the presence and intensity of pain was done immediately after transfer to the ward (0 h) and at 4 h, 6 h , 12 h and 24 h after surgery both at rest and with movement (turning from side to side) by using verbally administered Numerical rating scale pain assessment tools.
- The incidence of perioperative complications including bradycardia, hypotension, nausea and vomiting, localized hematoma, infection, or pruritis.
- Incidence of chronic pain at 3 \& 6 months.
- Conditions
- Iliohypogastric and Ilioinguinal Nerve Block for Acute and Chronic Pain in Cesarean Section
- Being tested
- Iliohypogastric and ilioinguinal nerve block, Controlled Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iliohypogastric and ilioinguinal nerve blockProcedure or surgery
Each patient will receive spinal anesthesia plus bilateral ultrasound-guided IL/IH nerve block. The abdomen will be scanned through anterior superior iliac spine (ASIS)-umbilicus line. Ilioinguinal nerve can be visualized between the internal oblique and transverse or external oblique muscles and within 1 to 3 cm from the ASIS. The iliohypogastric nerve lies immediately adjacent. After negative aspiration (to exclude intravascular injection), 10 mL of 0.25% bupivacaine will be injected. The same technique will be performed on the other side
Controlled GroupProcedure or surgery
Each patient will receive spinal anesthesia alone with no block.
| Study group | Role | What they receive |
|---|---|---|
| Ilioinguinal iliohypogastric Block | Experimental | Each patient will receive spinal anesthesia plus bilateral ultrasound-guided IL/IH nerve block. The abdomen will be scanned through anterior superior iliac spine (ASIS)-umbilicus line. Ilioinguinal nerve can be visualized between the internal oblique and transverse or external oblique muscles and within 1 to 3 cm from the ASIS. The iliohypogastric nerve lies immediately adjacent. After negative aspiration (to exclude intravascular injection), 10 mL of 0.25% bupivacaine will be injected. The same technique will be performed on the other side Receives: Procedure: Iliohypogastric and ilioinguinal nerve block |
| Controlled Group | Other | Each patient will receive spinal anesthesia alone with no block. Receives: Procedure: Controlled Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total dose of morphine used Patients rescue analgesia within first 24h postoperative
The total dose of morphine used postoperatively/patient (rescue analgesia) within first 24 h postoperative
Measured: up to 24 hours postoperative
Secondary outcomes (1)
Incidence of chronic pain at 3 & 6 months.
Incidence of chronic pain at 3 \& 6 months.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start20 Sep 2020
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iliohypogastric and Ilioinguinal Nerve Block for Acute and Chronic Pain in Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Arafa Elbadry, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04526015
- Sponsor's protocol ID
- Pain relief for c.s
- Status last verified
- Sep 2021
- First submitted
- 21 Aug 2020
- Last updated
- 5 Sep 2021
- 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 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Effect of Iliohypogastric and Ilioinguinal Nerve Block for Acute and Chronic Pain Relief After Cesarean Section Delivery.Randomized Controlled Study Post
- ClinicalTrials.gov ID
- NCT04526015
- Acronym / sponsor ID
- Pain relief for c.s
- Conditions
- Iliohypogastric and Ilioinguinal Nerve Block for Acute and Chronic Pain in Cesarean Section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 20 Sep 2020 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 25 Aug 2020 (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 increase in CS in recent years makes even a small prevalence of persistent pain after CS a significant burden, both financially and in terms of quality of life, for a large number of otherwise healthy young women. Persistent pain after CS has been shown to be associated with postpartum depression, interferes with daily activities, and causes sleep disturbances, all of which negatively and directly impact the mother. As a result, the care of the baby by the mother is affected negatively.
To adequately control postoperative pain, healthcare providers use a one-size-fits-all multimodal analgesic approach and sensible opioid prescription with monitoring to prevent addiction. The challenge is in tailoring this approach to the outliers who may be opioid tolerant or opioid-sensitive. However, the severity and duration of postoperative pain and its management may be predictive of developing persistent pain at two to 12 months or later.
Previous studies revealed different outcomes regarding the analgesic efficacy of II-IH nerve block for post caesarean pain, inguinal repair and surgery involving the female genital tract. Moreover, exploring the efficacy of II-IH nerve block could help to tackle sever postoperative pain after cesarean delivery particularly in settings where there is shortage of epidural kit supply and availability of strong opioids for pain management. We aimed to assess the analgesic efficacy of bilateral ilioinguinal and iliohypogastric nerve block for planned caesareans delivery under spinal anaesthesia and evaluate the incidence of persistent pain with transition from acute to chronic pain.
Detailed description
All patients will be assessed preoperatively by history taking, physical examination, and laboratory evaluation. On arrival of the patients to the operative room, electrocardiography, non-invasive blood pressure and pulse oximetry will be applied.
The patients will be positioned in sitting position to give the spinal anesthesia at L3-L4/L2-L3 intervertebral level in the midline approach. After local infiltration of skin and subcutaneous tissue with 2% lignocaine, 25 G B-braun spinal needle will be used to administer subarachnoid block (SAB) with 2.5 ml of hyperbaric bupivacaine (5%) and 20 µg of fentanyl after confirmation of free flow of cerebrospinal fluid (CSF) at the hub of the needle. Patients will be coloaded with 10-12 ml/kg (over the period of 15 min) of Ringer's Lactate (RL) solution at the time of SAB. Thereafter, patients will be placed in supine position with wedge under the right hip.
64 Patients were randomly allocated into two equal groups (each 32 patients):
- Group B (IL/IH group): Each patient will receive spinal anesthesia plus bilateral ultrasound-guided IL/IH nerve block. The abdomen will be scanned through anterior superior iliac spine (ASIS)-umbilicus line. Ilioinguinal nerve can be visualized between the internal oblique and transverse or external oblique muscles and within 1 to 3 cm from the ASIS. The iliohypogastric nerve lies immediately adjacent. After negative aspiration (to exclude intravascular injection), 10 mL of 0.25% bupivacaine will be injected. The same technique will be performed on the other side
- Group C (Controlled group): Each patient will receive spinal anesthesia alone with no block.
Postoperative Analgesia Protocol
All patients will be given a standardized patient controlled intravenous analgesia (PCIA) regimen. The disposable PCIA device (Coopdech Syrinjector PCA set; Daiken Medical) contained 30 mg morphine in 45 ml saline. Patients will be instructed on how to use the PCIA device, which was set with a bolus of 2 mg morphine and a minimum interval of 30 min. If the analgesic effect was not satisfactory, complementary use of intravenous morphine will be applied.
Assessment of Acute Postoperative Pain
At 24 hours after surgery, pain intensity will be recorded on a 10-point verbal pain rating scale ranging from 0 to 10 (VPRS; 0 = no pain to 10 = worst pain imaginable), at rest (VPRS-R) and while moving into the sitting position (VPRS-S). Pain will be considered none, mild, moderate, or severe if scored 0, 1 to 3, 4 to 6, or 7 to 10, respectively.
Assessment of Persistent Postoperative Pain (3 and 6 Months) The Short-Form McGill Pain Questionnaire-Revised (SFMPQ- 2) was designed specifically and validated to assess both neuropathic and non-neuropathic aspects of chronic pain.
Women will report their average and worst pain the week prior to and at the time of the telephone interview using a previously developed scripted telephone interview. Persistent pain will be defined as new onset of pain related to the CS, located around the scar or in the abdomen, and still present at 8 weeks. Chronic pain will be defined if same symptoms were still present at 3 and 6 months.
Measurements The following parameters will be recorded by an anesthesia resident not included in the study and blinded to its groups: -
- Demographic data (Age in month, body mass index, and ASA class)
- Total consumption of analgesia (mg/kg) in first day postoperatively. (Primary outcome)
- The time to the first rescue analgesic request. (Secondary outcome) The postoperative pain score (NRS pain score). Assessment of the presence and intensity of pain was done immediately after transfer to the ward (0 h) and at 4 h, 6 h , 12 h and 24 h after surgery both at rest and with movement (turning from side to side) by using verbally administered Numerical rating scale pain assessment tools.
- The incidence of perioperative complications including bradycardia, hypotension, nausea and vomiting, localized hematoma, infection, or pruritis.
- Incidence of chronic pain at 3 \& 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ilioinguinal iliohypogastric Block | Experimental | Procedure: Iliohypogastric and ilioinguinal nerve blockEach patient will receive spinal anesthesia plus bilateral ultrasound-guided IL/IH nerve block. The abdomen will be scanned through anterior superior iliac spine (ASIS)-umbilicus line. Ilioinguinal nerve can be visualized between the internal oblique and transverse or external oblique muscles and within 1 to 3 cm from the ASIS. The iliohypogastric nerve lies immediately adjacent. After negative aspiration (to exclude intravascular injection), 10 mL of 0.25% bupivacaine will be injected. The same technique will be performed on the other side |
| Controlled Group | Other | Procedure: Controlled GroupEach patient will receive spinal anesthesia alone with no block. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pregnant female.less than 40 years .
- ASA l,ll full term scheduled for elective cesarean section
Key exclusion criteria (7 listed)
- patient refusal
- Emergency section
- More than I prior section
- Current pain disorder
- Allergy to local anesthetic
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 |
|---|---|---|
| Iliohypogastric and ilioinguinal nerve blockEach patient will receive spinal anesthesia plus bilateral ultrasound-guided IL/IH nerve block. The abdomen will be scanned through anterior superior iliac spine (ASIS)-umbilicus line. Ilioinguinal nerve can be visualized between the internal oblique and transverse or external oblique muscles and within 1 to 3 cm from the ASIS. The iliohypogastric nerve lies immediately adjacent. After negative aspiration (to exclude intravascular injection), 10 mL of 0.25% bupivacaine will be injected. The same technique will be performed on the other side | Procedure or surgery | Ilioinguinal iliohypogastric Block |
| Controlled GroupEach patient will receive spinal anesthesia alone with no block. | Procedure or surgery | Controlled Group |
Primary outcome
The total dose of morphine used Patients rescue analgesia within first 24h postoperative
Time frame: up to 24 hours postoperative
The total dose of morphine used postoperatively/patient (rescue analgesia) within first 24 h postoperative
1 secondary outcome
Incidence of chronic pain at 3 & 6 months.
Time frame: up to 6 months
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 5 Sep 2021.
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 Iliohypogastric and ilioinguinal nerve block in people with Iliohypogastric and Ilioinguinal Nerve Block for Acute and Chronic Pain in Cesarean Section, run by Tanta 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 2 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 5 Sep 2021. 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.
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 total dose of morphine used Patients rescue analgesia within first 24h postoperative (time frame: up to 24 hours postoperative). 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 5 Sep 2021.