- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04526015
Iliohypogastric and Ilioinguinal Nerve Block for Acute and Chronic Pain Relief After Cesarean Section.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
ELgharbiaa
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Tanta, ELgharbiaa, Egypt, 31527
- Tanta University hospitals
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pregnant female.less than 40 years .
- ASA l,ll full term scheduled for elective cesarean section
Exclusion Criteria:
- patient refusal
- Emergency section
- More than I prior section
- Current pain disorder
- Allergy to local anesthetic
- Coagulopathy
- Major cardiac,renal, hepatic disorder
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ilioinguinal iliohypogastric Block
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
|
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
|
Other: Controlled Group
Each patient will receive spinal anesthesia alone with no block.
|
Each patient will receive spinal anesthesia alone with no block.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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up to 24 hours postoperative
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of chronic pain at 3 & 6 months.
Time Frame: up to 6 months
|
Incidence of chronic pain at 3 & 6 months.
|
up to 6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pain relief for c.s
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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Clinical Trials on Iliohypogastric and Ilioinguinal Nerve Block for Acute and Chronic Pain in Cesarean Section
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Peking University People's HospitalEnrolling by invitationCesarean Section | Quadratus Lumborum Block | Iliohypogastric/Ilioinguinal Nerve BlockChina
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Al-Azhar UniversityRecruitingAcute Pain | Cesarean Section | Bupivacaine | Ultrasound Guided Transversus Abdominis Plane Block | Surgical Transversus Abdominis Plane BlockEgypt
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Bursa Yüksek İhtisas Education and Research HospitalCompletedIlioinguinal Nerve BlockTurkey
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Sohag UniversityCompletedPain Management in Adult Females in Child Bearing Period Aging From 20 to 45 Years Who Are Scheduled for Elective Cesarean SectionEgypt
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Nordsjaellands HospitalRecruitingChronic Pain | Cesarean Section Complications | Cesarean Section | SMS | Cesarean Delivery | Questionnaire | Persistent PainDenmark
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Cairo UniversityActive, not recruiting
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Zagazig UniversityCompletedHernioplasty | Ilioinguinal Nerve Section | Pain PreventionEgypt
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Istanbul Saglik Bilimleri UniversityCompletedPain, Postoperative | Cesarean Section | Erector Spinae Plane Block | Transversus Abdominis Plane BlockTurkey
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E-DA HospitalNot yet recruitingCesarean Section | Post Operative Pain, Acute | Post Operative Pain, ChronicTaiwan
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Vicki Modest, MDCompletedReduction in Post Ceasarean-section Related Pain in Study Group (TAP Block)Uganda
Clinical Trials on Iliohypogastric and ilioinguinal nerve block
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Bursa Yüksek İhtisas Education and Research HospitalNot yet recruitingChild | Nerve Block | Perfusion Index | Anesthesia, Regional | Anesthesia, Caudal | Inguinal Hernia Unilateral | PlethysmographyTurkey
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Kazuhiko Okuyama, MDCompletedThe Comparison of the Transversalis Fascia Plane Block With Ilioinguinal/Iliohypogastric Nerve BlockPostoperative Pain | Children, Only | Inguinal Hernia UnilateralJapan
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Mansoura UniversityCompleted
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Peking University People's HospitalEnrolling by invitationCesarean Section | Quadratus Lumborum Block | Iliohypogastric/Ilioinguinal Nerve BlockChina
-
Tanta UniversityCompleted
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Sisli Hamidiye Etfal Training and Research HospitalCompletedInguinal Hernia | Post Operative Pain | Quadratus Lumborum Nerve BlockTurkey
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Hillel Yaffe Medical CenterUnknown
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Tanta UniversityNot yet recruiting
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Sultan Qaboos UniversityRecruitingAnalgesia | Varicocele | Hydrocele | Inguinal Surgery | Undescended Testes | Torsion Testis | Ilioinguinal Nerve BlockOman
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Cairo UniversityCompleted