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

NCT ID: NCT06108895

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-03-31

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 ?.

Detailed Description

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.

During the preoperative visit, parturient will be explained how to use pain numeric rating scale (PNRS), post-operative nausea and vomiting (PONV) intensity scale, and Likert 4 point satisfaction scale.

The participated parturients will be divided randomly using a computer generated random table into three equal groups thirty patient each; C, I, and M. Group C, control group; will receive intrathecal 12.5 mg hyperbaric bupivacaine 0.5% (2.5ml). Group I; will receive intrathecal 12.5 mg hyperbaric bupivacaine 0.5% (2.5ml) plus bilateral ultrasound guided IINB at the end of surgery after suturing and dressing the wound. Group M; will receive intrathecal 12.5 mg hyperbaric bupivacaine 0.5% plus 200 mcg morphine in 2.5ml solution.

In the morning of surgery; all participants will be administered IV infusion of 40mg pantoprazole diluted in 500 ml of lactated ringer over 30 min. Pulse oximeter, ECG and noninvasive blood pressure will be connected to the participant on arrival to the operating room. Spinal anesthesia will be given in the sitting position under complete aseptic precaution at L3-4 or L4-5 subarachnoid space with a 25 or 27 gauge Sprotte spinal needle. Loss of Light touch sensation on the mid-clavicular line below T 7 will be considered adequate for start of surgery.

Ultrasound guided IINB 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 the umbilicus using a linear probe (4-12hertz). Ilioinguinal and iliohypogastric nerves will be identified in the plane between the internal oblique muscle and the 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 on the other side.

All parturients will be given IV acetaminophen 1g/8h and IV Lornoxicam 8mg/12h. Rescue IV 3mg morphine will be given if pain score ≥ 4 is reported during the first post-operative 24 hours.

The following parameters will be recorded; demographics, vital signs, and quality of postoperative analgesia using the PNRS, ranging from 0 (no pain) to 10 (severe pain); at rest and during movement in the following time points: Time 0; end of surgery (T0), T1 (4 hours after surgery), T2 (6 hours after surgery), T3 (12 hours after surgery), T4 (18 hours after surgery), T 5 (24 hours after surgery), T 6 (36 hours after surgery), T 7 (48 hours after surgery), and T8 (72 hours after surgery), total amount of rescue morphine during the first 24h after surgery, time to first ambulation, and complications including pruritus, PONV using the PONV intensity score, sedation using Ramsey sedation score, respiratory depression (respiratory rate ≤ 8/min), and complications related to IINB as improper block, pain, hematoma or infection at the site of injection. Patient's satisfaction will be assessed 72 hours after surgery using Likert 4 point scale. A single researcher who will be blinded to groups will be responsible for all measurements and data collection.

Conditions

Cesarean Section; Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group C, control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Group I

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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 M

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

Group Type: ACTIVE_COMPARATOR

intrathecal morphine

Intervention Type: OTHER

200 mcg morphine intrathecally with bupivacaine

Interventions

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

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.

Intervention Type: OTHER

intrathecal morphine

200 mcg morphine intrathecally with bupivacaine

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Sobhy Mohamed Basyouni

professor of anethesia and critical care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed S Basyouni, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Tanta University

Tanta, Gharbiah, Egypt

Countries

Egypt

References

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 10598635 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19020158 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17570011 (View on PubMed)

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

Reference Type: 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.

Reference Type: RESULT

PMID: 12059890 (View on PubMed)

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.

Reference Type: RESULT

PMID: 35991778 (View on PubMed)

Other Identifiers

36264PR333/9/23

Identifier Type: -

Identifier Source: org_study_id