Ilioinguinal Iliohypogastric Nerve Block as Adjunct to Spinal Anesthesia for Cesarean Section

NCT06108895 | Completed

• 1 other identifier: 36264PR333/9/23
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present controlled randomized study is to compare between ilioinguinal/iliohypogastric nerve block (IINB) and morphine as adjuncts to spinal anesthesia for cesarean section regarding quality of post-operative analgesia. The researchers will compare between the following groups: Group C, control group; will receive intrathecal 12.5 mg hyperbaric bupivacaine 0.5%, Group I; will receive intrathecal 12.5 mg hyperbaric bupivacaine 0.5% plus bilateral ultrasound guided IINB, and Group M; will receive intrathecal 12.5 mg hyperbaric bupivacaine 0.5% plus 200 mcg morphine to answer the question: Could IINB be an alternative to intrathecal morphine during spinal anesthesia for cesarean section ?.

Conditions

Cesarean Section; Post Operative Pain

Keywords

Ilioinguinal/Iliohypogatric; Peripheral Nerve Block; Cesarean Section

Outcome Measures

Primary Outcomes (5)

• pain numeric rating score at rest

  Patients are asked to circle the number between 0 and 10 that fits best to their pain intensity. 0 represents 'no pain at all' where as 10 represents 'the worst pain ever possible'.

  Time 0: at end of surgery (T0); then 4hours (T1), 6hours (T2), 12hours (T3), 18hours (T4), 24hours (T5), 36hours (T6), 48hours (T7), and 72hours (T8) after surgery

• pain numeric rating score during movement

  Patients are asked to circle the number between 0 and 10 that fits best to their pain intensity. 0 represents 'no pain at all' where as 10 represents 'the worst pain ever possible'.

  Time 0: at end of surgery (T0); then 4hours (T1), 6hours (T2), 12hours (T3), 18hours (T4), 24hours (T5), 36hours (T6), 48hours (T7), and 72hours (T8) after surgery

• total amounts of rescue morphine

  total amount of intravenous rescue morphine

  at the end of the first 24 hours after surgery

• time to first ambulation

  number of hours from end of surgery to the time the pateint left the bed

  the time the patient left the bed

• complications

  pruritus, post-operative nausea and vomiting (PONV) using the PONV intensity score, sedation using Ramsey sedation score, respiratory depression (respiratory rate ≤ 8/min.), and complication related to IINB as improper block, pain, hematoma or infection at the site of injection.

  during the first 72 hours after surgery

Secondary Outcomes (1)

• Patients' satisfaction

  72 hours after surgery

Study Arms (3)

Group C, control group

NO INTERVENTION

it will receive intrathecal 12.5 mg (2.5ml) hyperbaric bupivacaine 0.5%.

Group I

ACTIVE COMPARATOR

it will receive intrathecal 12.5 mg (2.5ml) hyperbaric bupivacaine 0.5% plus bilateral ultrasound guided IINB after surgery.

Other: ilio-inguinal/ilio-hypogastric nerve block (IINB)

Group M

ACTIVE COMPARATOR

it will receive intrathecal 12.5 mg hyperbaric bupivacaine 0.5% plus 200 mcg morphine in 2.5ml solution.

Other: intrathecal morphine

Interventions

ilio-inguinal/ilio-hypogastric nerve block (IINB) OTHER

Ultrasound-guided IINBs will be performed by scanning the anterior abdominal wall superior and medial to the anterior superior iliac spine in a line between the anterior superior iliac spine and umbilicus using a linear probe (4-12hertz). Ilioinguinal and iliohypogastric nerves will be identified in the plane between internal oblique muscle and transversus abdominis muscle. After negative aspiration of blood, 20 ml plain bupivacaine 0.25% plus 4mg dexamesathone will be injected. The same technique will be performed in the other side.

Group I

intrathecal morphine OTHER

200 mcg morphine intrathecally with bupivacaine

Group M

Eligibility Criteria

• Age: 21 Years - 40 Years
• Gender Eligibility Details: full term healthy non laboring parturient between 21 and 40 years of age who had normal singleton pregnancy scheduled for elective lower segment cesarean section through a Pfannensteil incision under spinal anesthesia will be recruited in the study after obtaining an informed written consent
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ninty full term healthy non laboring parturient between 21 and 40 years of age who had normal singleton pregnancy scheduled for elective lower segment cesarean section through a Pfannensteil incision under spinal anesthesia will be recruited in the study after obtaining an informed written consent

You may not qualify if:

• if they were using any medications other than prenatal vitamins, requiring an emergent cesarean section, having antepartum bleeding, diabetes mellitus, preeclampsia, eclampsia, history of substance abuse, or progressive neurological disease, having contraindication to spinal anesthesia as allergy to the study medications or infection at the site of injection, or they refused to participate in the study.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, Gharbiah, Egypt

Location

Related Publications (7)

• DeSousa KA, Chandran R. intrathecal morphine for postoperative analgesia: current trends. World J Anesthesiol 2014; 3(3): 191-202

  BACKGROUND

• Dahl JB, Jeppesen IS, Jorgensen H, Wetterslev J, Moiniche S. Intraoperative and postoperative analgesic efficacy and adverse effects of intrathecal opioids in patients undergoing cesarean section with spinal anesthesia: a qualitative and quantitative systematic review of randomized controlled trials. Anesthesiology. 1999 Dec;91(6):1919-27. doi: 10.1097/00000542-199912000-00045. No abstract available.

  PMID: 10598635 BACKGROUND

• Carney J, McDonnell JG, Ochana A, Bhinder R, Laffey JG. The transversus abdominis plane block provides effective postoperative analgesia in patients undergoing total abdominal hysterectomy. Anesth Analg. 2008 Dec;107(6):2056-60. doi: 10.1213/ane.0b013e3181871313.

  PMID: 19020158 BACKGROUND

• Hu P, Harmon D, Frizelle H. Ultrasound guidance for ilioinguinal/iliohypogastric nerve block: a pilot study. Ir J Med Sci. 2007 Jul-Sep;176(2):111-5. doi: 10.1007/s11845-007-0017-y. Epub 2007 Mar 20.

  PMID: 17570011 BACKGROUND

• Krishnegowda S, Pujari VS, Doddagavanahalli SRC, Bevinaguddaiah y, Parate LH.A Randomized Control Trial on the Efficacy of Bilateral Ilioinguinal Iliohypogastric Nerve Block and Local Infiltration for Post Caesarean Delivery Analgesia. Journal of Obstetric Anaesthesia and Critical Care 2020; 10(1): 32-37

  BACKGROUND

• Aasbo V, Thuen A, Raeder J. Improved long-lasting postoperative analgesia, recovery function and patient satisfaction after inguinal hernia repair with inguinal field block compared with general anesthesia. Acta Anaesthesiol Scand. 2002 Jul;46(6):674-8. doi: 10.1034/j.1399-6576.2002.460607.x.

  PMID: 12059890 RESULT

• Elahwal L, Elrahwan S, Elbadry AA. Ilioinguinal and Iliohypogastric Nerve Block for Acute and Chronic Pain Relief After Caesarean Section: A Randomized Controlled Trial. Anesth Pain Med. 2022 Mar 27;12(2):e121837. doi: 10.5812/aapm.121837. eCollection 2022 Apr.

  PMID: 35991778 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Ahmed S Basyouni, MD

  Anesthesia, intensive care, and pain management department; Tanta University, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A single researcher who will be blinded to groups will be responsible for all measurements and data collection.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of anethesia and critical care

Model Details: Ninty parturients who had normal singleton pregnancy scheduled for elective lower segment cesarean section through a Pfannensteil incision under spinal anesthesia will be recruited in the study. They will be randomly divided into three equal groups; Group C, control group who will receive spinal anesthesia; Group M who will receive spinal anesthesia with intrathecal morphine, and group I who will receive spinal anesthesia and IINB

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: October 31, 2023
• Study Start: November 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: March 31, 2024
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)