Influence of Surgical Regional Anesthesia on Postoperative Pain

Charite University, Berlin, Germany171 enrolled

Overview

To compare three Types of anesthetic techniques (Spinal anesthesia, Combined spinal epidural anesthesia, Combined spinal epidural anesthesia with indwelling catheter for 24 hrs) on pain after elective cesarean section.

Regional analgesia is the most effective way of providing analgesia during labor and delivery. By using a combination of local anesthetics and opioids, it is often possible to avoid motor block. Spinal anesthesia is suitable for most elective cesarean sections. Epidural anesthesia and in particular catheter based epidural anesthesia allow a gradual extension of anesthesia and are suitable for prolonged treatment of postoperative pain. It is unclear which anesthetic technique provides better pain relief after cesarean section. This prospective, randomized study compares the effectiveness of three types of regional anesthetic techniques (Spinal anesthesia, Combined spinal epidural anesthesia, Combined spinal epidural anesthesia with indwelling catheter for 24 hrs) on pain after elective cesarean section.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

171

Conditions

Elective Cesarean Section

Interventions

SPAPROCEDURE

Spinal anesthesia and opioids

CSEPROCEDURE

CSE and epidural opioids

CSEPCEAPROCEDURE

CSE and continuous epidural patient controlled analgesia using an epidural catheter for 24 hrs

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female patients aged greater than or equal to 18 years * Patients without severe illnesses (American Society of Anaesthesiologists \[ASA\] grade II-III) * Patients for elective cesarean sections * Informing patients about risks and complications of anesthesia until 24 hrs before operation Exclusion Criteria: * Lacking willingness to regional procedures * No offered patient information and written informed consent * Persons without the capacity to consent * Unability of German language use * Preterm delivery \< 28 weeks of pregnancy * Chronic pain or chronic analgesic intake in medical history * Alcohol, dope and medication abuse * Psychiatric disease in medical history * Baby death after delivery * Anxiolytic medication * Allergy to local anaesthetics * History of bleeding tendency * Eclampsia and HELLP syndrome * Elective section out work routine time * Participation in another clinical trial during the trial, one month before screening and three months after screening

Locations (1)

Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Campus Charité Mitte, Charite University, Berlin

Berlin, State of Berlin, Germany

Outcomes

Primary Outcomes

Postoperative pain levels during movement (cough)

Patient self-assessed postoperative pain levels during movement (cough) using an unmarked zero to one hundred mm visual analog scale (VAS)

Time frame: At nine hours after the end of surgery (closure time)

Secondary Outcomes

Postoperative pain levels during rest

Patient self-assessed postoperative pain levels during rest using an unmarked zero to one hundred mm visual analog scale (VAS)

Time frame: At nine hours after the end of surgery (closure time)

Postoperative pain levels during rest and movement

Patient self-assessed postoperative pain levels during rest and movement using an unmarked zero to one hundred mm visual analog scale (VAS)

Time frame: At zero (injection), one, two, six, nine, twenty four, fourty eight hours after the end of surgery (closure time)

Change of type of anesthesia when regional anesthesia fails

Time frame: During the operation

Level of anesthesia during the operation

Time frame: During the operation

Incidence of hypotensions during the operation

Time frame: During the operation

Sedation level (Ramsay-Score)

Time frame: Postoperative course

Capability for mobilisation and time to first mobilisation

Time frame: Postoperative course

Incidence of adverse reactions (PONV, headache and backpain, urinary retention)

Data from ClinicalTrials.gov

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