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Completed

NCT Number: NCT06010602

Postoperative Analgesia in Cesarean Delivery

İn this study, 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.

this study 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:

1. To compare the amount of total analgesic use in the first 24 hours in patients 2. To compare the NRS (Numering rating scale) values (resting and dynamic) at 2. 4. 8. 12 . 24. hours in the postoperative follow-up of the patients 3. Comparing the side effects such as postoperative nausea and vomiting

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Key information

Conditions

Postoperative Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gaziosmanpasa Research and Education Hospital

Istanbul, 34000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged between 18 and 40
  • ASA 2 risk group
  • Patients at 37-41 weeks of pregnancy
  • undergoing cesarean section under spinal anesthesia

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.

Treatment and study plan

quadratus lumborum block

Procedure

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

İlioinguinal-İliohipogastric nerve block

Procedure

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

Primary outcomes

  1. Comparison of first rescue analgesia

    Time frame: 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 outcomes

  1. comparing the amount of total analgesic use in the first 24 hours in patients

    Time frame: 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.

  2. Comparing the NRS values in 2,4,8,12,24 hours in the postoperative follow-up of the patients

    Time frame: 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.

  3. Comparing side effects such as postoperative nausea and vomiting

    Time frame: 24 hours

    To compare postoperative side effects such as nausea and vomiting within the first 24 hours.

Sponsors and collaborators

Lead sponsor

Gaziosmanpasa Research and Education Hospital

Other Gov

Registry information

Official study title

COMPARISON OF THE POSTOPERATIVE ANALGESIC EFFECTIVENESS OF QUADRATUS LUMBORUM BLOCK and ILIOINGUINAL -ILIOHIPOGASTRIC NERVE BLOCK IN CESAREAN SECTION OPERATIONS

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Aug 24, 2023
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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