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

NCT04526015 | Completed

• 1 other identifier: Pain relief for c.s
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

  up to 24 hours postoperative

Secondary Outcomes (1)

• Incidence of chronic pain at 3 & 6 months.

  up to 6 months

Study Arms (2)

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

Procedure: Iliohypogastric and ilioinguinal nerve block

Controlled Group

OTHER

Each patient will receive spinal anesthesia alone with no block.

Procedure: Controlled Group

Interventions

Iliohypogastric and ilioinguinal nerve block PROCEDURE

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

Ilioinguinal iliohypogastric Block

Controlled Group PROCEDURE

Each patient will receive spinal anesthesia alone with no block.

Controlled Group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant female.less than 40 years .
• ASA l,ll full term scheduled for elective cesarean section

You may not qualify if:

• patient refusal
• Emergency section
• More than I prior section
• Current pain disorder
• Allergy to local anesthetic
• Coagulopathy
• Major cardiac,renal, hepatic disorder

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, ELgharbiaa, 31527, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: August 25, 2020
• Study Start: September 20, 2020
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: September 5, 2021

Record last verified: 2021-09

Locations

EG (1)