Postoperative Analgesia After Cesarean Section

Sponsor

Gaziosmanpasa Research and Education Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06010602

Collaborator

(none)

Enrollment

Location

Arms

7.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

We planned to compare the post-operative analgesic efficacy of Ilioinguinal iliohypogastric (II-IH) nerve block and Quadratus lumborum III Block in elective cesarean section operations.

Our primary aim is; To compare and evaluate the first rescue analgesia requirement times after Quadratus lumborum III and II-IH Block for postoperative analgesia after elective cesarean section operations under spinal anesthesia.

Our secondary aims are:

To compare the amount of total analgesic use in the first 24 hours in patients
To compare the NRS (Numering rating scale) values (resting and dynamic) at 2. 4. 8. 12 .
hours in the postoperative follow-up of the patients
Comparing the side effects such as postoperative nausea and vomiting

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Procedure: Quadratus lumborum block Procedure: İlioinguinal-İliohipogastric nerve block	N/A

Detailed Description

Patients who underwent elective cesarean section under spinal anesthesia will be divided into two groups at the end of the operation, using the closed envelope randomization method as Quadratus lumborum III and II-IH nerve block. Spinal anesthesia will be applied to all patients who will undergo elective cesarean section. At the end of the operation, they will be taken to the postoperative block room. All blocks will be performed by the same anesthesiologist under USG guidance. 20 ml of 0.25% bupivacaine will be used in the blocks. All patients will be followed in the block room for 30 minutes after the block application. Patients with a Modified Aldret score above 8 will be sent to the service because they are under spinal anesthesia at the end of the operation.At the end of the operation, when the spinal level regresses to two dermatome levels, paracetamol 1gr IV will be administered to all patients for post-op analgesia.Postoperative analgesia was planned for the patients as paracetamol 4x1 gr. Tramadol hydrochloride 1mg/kg was planned as rescue analgesia in the ward for patients with NRS scores greater than 3 in their postoperative follow-up.

Patients 2.,4.,8.,12.,24. hours will be followed by an anesthesia assistant who is different from the researcher who applied the block and who is blind for the study. The patients' first rescue analgesia times, NRS scores, postoperative side effects, and total analgesic amounts used in 24 hours will be recorded.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

COMPARISON OF THE POSTOPERATIVE ANALGESIC EFFECTIVENESS OF QUADRATUS LUMBORUM BLOCK (QLB) and ILIOINGUINAL -ILIOHIPOGASTRIC (II-IH) NERVE BLOCK IN CAESER SECTION OPERATIONS

Actual Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Quadratus lumborum block group the patient In the lateral decubitus position, a subcostal area and above the iliac crest in the mid-axillary line, a convex ultrasound probe is placed under sterile conditions. Using an in-plane technique, the quadratus lumborum and psoas major muscles, as well as the transverse process of the L4 vertebra, are visualized. 22G, 100 mm peripheral block needle is used to perform the block. The needle is directed between the quadratus lumborum muscle and the psoas major muscle in the subfascial plane, following hydrodissection for proper needle placement. Then, 20 mL of 0.25% bupivacaine is injected slowly, aspirating every 5 cc to ensure proper spread. The injection is performed under ultrasound guidance, visualizing the local anesthetic pushing the fascia. The same procedure will be repeated for the other side.	Procedure: Quadratus lumborum block For all patients, postoperative analgesia was planned as paracetamol 1g four times a day for the first 24 hours after surgery. Patients with Numeric Rating Scale (NRS) scores greater than 3 at 2, 4, 8, 12, and 24 hours postoperatively were administered rescue analgesia with tramadol hydrochloride at a dose of 1mg/kg. Other Names: Intravenous analgesic medication
Active Comparator: İlioinguinal-İliohipogastric nerve block group the patient in the supine position, a linear ultrasound probe is placed over the spina iliaca anterior superior (SIAS) line, drawn from SIAS to the umbilicus. The probe is used to visualize the abdominal wall muscles, focusing on the fascial plane between the transversus abdominis and internal oblique muscles, where a flattened football-like appearance is seen. The iliohypogastric nerve is observed more laterally, and the ilioinguinal nerve is seen more medially. Using an in-plane technique with 22G, 100 mm peripheral block needle, local anesthetic is injected near the SIAS, between the transversus abdominis and internal oblique muscles. Again, 20 mL of 0.25% bupivacaine is injected slowly, aspirating every 5 cc, and the injection is visualized under ultrasound guidance, ensuring proper fascial spread. The same procedure will be repeated for the other side.	Procedure: İlioinguinal-İliohipogastric nerve block For all patients, postoperative analgesia was planned as paracetamol 1g four times a day for the first 24 hours after surgery. Patients with Numeric Rating Scale (NRS) scores greater than 3 at 2, 4, 8, 12, and 24 hours postoperatively were administered rescue analgesia with tramadol hydrochloride at a dose of 1mg/kg. Other Names: Intravenous analgesic medication

Arm

Intervention/Treatment

Active Comparator: Quadratus lumborum block group

the patient In the lateral decubitus position, a subcostal area and above the iliac crest in the mid-axillary line, a convex ultrasound probe is placed under sterile conditions. Using an in-plane technique, the quadratus lumborum and psoas major muscles, as well as the transverse process of the L4 vertebra, are visualized. 22G, 100 mm peripheral block needle is used to perform the block. The needle is directed between the quadratus lumborum muscle and the psoas major muscle in the subfascial plane, following hydrodissection for proper needle placement. Then, 20 mL of 0.25% bupivacaine is injected slowly, aspirating every 5 cc to ensure proper spread. The injection is performed under ultrasound guidance, visualizing the local anesthetic pushing the fascia. The same procedure will be repeated for the other side.

Procedure: Quadratus lumborum block

For all patients, postoperative analgesia was planned as paracetamol 1g four times a day for the first 24 hours after surgery. Patients with Numeric Rating Scale (NRS) scores greater than 3 at 2, 4, 8, 12, and 24 hours postoperatively were administered rescue analgesia with tramadol hydrochloride at a dose of 1mg/kg.

Other Names:

Intravenous analgesic medication

Active Comparator: İlioinguinal-İliohipogastric nerve block group

the patient in the supine position, a linear ultrasound probe is placed over the spina iliaca anterior superior (SIAS) line, drawn from SIAS to the umbilicus. The probe is used to visualize the abdominal wall muscles, focusing on the fascial plane between the transversus abdominis and internal oblique muscles, where a flattened football-like appearance is seen. The iliohypogastric nerve is observed more laterally, and the ilioinguinal nerve is seen more medially. Using an in-plane technique with 22G, 100 mm peripheral block needle, local anesthetic is injected near the SIAS, between the transversus abdominis and internal oblique muscles. Again, 20 mL of 0.25% bupivacaine is injected slowly, aspirating every 5 cc, and the injection is visualized under ultrasound guidance, ensuring proper fascial spread. The same procedure will be repeated for the other side.

Procedure: İlioinguinal-İliohipogastric nerve block

Other Names:

Intravenous analgesic medication

Outcome Measures

Primary Outcome Measures

Comparison of first rescue analgesia [24 hour]
For all patients, postoperative analgesia was planned as paracetamol 1g four times a day for the first 24 hours after surgery. Patients with Numeric Rating Scale (NRS) scores greater than 3 at 2, 4, 8, 12, and 24 hours postoperatively will receive rescue analgesia with tramadol hydrochloride at a dose of 1mg/kg. The time of the first administration of tramadol hydrochloride for each patient will be compared.

Secondary Outcome Measures

comparing the amount of total analgesic use in the first 24 hours in patients [24 hours]
For all patients, postoperative analgesia was planned as paracetamol 1g four times a day for the first 24 hours after surgery. Patients with Numeric Rating Scale (NRS) scores greater than 3 at 2, 4, 8, 12, and 24 hours postoperatively will receive rescue analgesia with tramadol hydrochloride at a dose of 1mg/kg.The total tramadol consumption of patients within the first 24 hours will be compared.
Comparing the NRS values in 2,4,8,12,24 hours in the postoperative follow-up of the patients [24 hours]
To compare the Numeric Rating Scale (NRS) values (at rest and with movement) of the patients during postoperative follow-ups at 2, 4, 8, 12, and 24 hours.
Comparing side effects such as postoperative nausea and vomiting [24 hours]
To compare postoperative side effects such as nausea and vomiting within the first 24 hours.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria: ASA 1-2, Patients at 37-41 weeks of pregnancy

Exclusion Criteria:

The patient does not accept the procedure. Patients with a history of eclampsia and preeclampsia during pregnancy local anesthetic allergy Infection at the procedure site Anticoagulant use with bleeding disorder Chronic analgesia and opioid use Mental, psychiatric and neurological problems Patients with ASA 3 and above with a history of any chronic disease.