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Iliohypogastric and Ilioinguinal Nerve Block for Acute and Chronic Pain Relief After Cesarean Section.

Primary Purpose

Iliohypogastric and Ilioinguinal Nerve Block for Acute and Chronic Pain in Cesarean Section

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Iliohypogastric and ilioinguinal nerve block
Controlled Group
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iliohypogastric and Ilioinguinal Nerve Block for Acute and Chronic Pain in Cesarean Section

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Tanta University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Ilioinguinal iliohypogastric Block

Controlled Group

Arm Description

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 alone with no block.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of chronic pain at 3 & 6 months.
Incidence of chronic pain at 3 & 6 months.

Full Information

First Posted
August 21, 2020
Last Updated
September 3, 2021
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT04526015
Brief Title
Iliohypogastric and Ilioinguinal Nerve Block for Acute and Chronic Pain Relief After Cesarean Section.
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 20, 2020 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
August 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iliohypogastric and Ilioinguinal Nerve Block for Acute and Chronic Pain in Cesarean Section

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ilioinguinal iliohypogastric Block
Arm Type
Experimental
Arm Description
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
Arm Title
Controlled Group
Arm Type
Other
Arm Description
Each patient will receive spinal anesthesia alone with no block.
Intervention Type
Procedure
Intervention Name(s)
Iliohypogastric and ilioinguinal nerve block
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Controlled Group
Intervention Description
Each patient will receive spinal anesthesia alone with no block.
Primary Outcome Measure Information:
Title
The total dose of morphine used Patients rescue analgesia within first 24h postoperative
Description
The total dose of morphine used postoperatively/patient (rescue analgesia) within first 24 h postoperative
Time Frame
up to 24 hours postoperative
Secondary Outcome Measure Information:
Title
Incidence of chronic pain at 3 & 6 months.
Description
Incidence of chronic pain at 3 & 6 months.
Time Frame
up to 6 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Tanta University Hospitals
City
Tanta
State/Province
ELgharbiaa
ZIP/Postal Code
31527
Country
Egypt

12. IPD Sharing Statement

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Iliohypogastric and Ilioinguinal Nerve Block for Acute and Chronic Pain Relief After Cesarean Section.

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