Clinical trial NCT03897764: A Novel Analgesic Method for Postoperative Pain Relief After Cesarean Section: Intraoperative Superior Hypogastric Block
Official title: A Novel Analgesic Method for Postoperative Pain Relief After Cesarean Section: Intraoperative Superior Hypogastric Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: cesarean section
postoperative pain
superior hypogastric block
Lead sponsor: Maltepe University
Sponsor class: OTHER
First posted: 2019-04-01
Enrollment: 154
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective double-blinded randomized placebo controlled study
Primary purpose: TREATMENT

Brief summary: Cesarean section is the most common inpatient surgical procedure in the United States with 1.3 million cesarean deliveries performed in 2015. Cesarean section frequency is increasing rapidly in worldwide, especially in middle and high income countries.

Postoperative pain is an expected outcome for patients following surgical procedures. Inadequate pain relief is still a common problem among hospitalized patients. Cesarean section ranked ninth for pain severity among 179 different surgical procedures.

Multimodal pain therapy has been suggested for postoperative pain management after cesarean delivery. The most commonly used modalities are systemic administration of opioids, either by intramuscular injection or IV by patient-controlled analgesia, and neuraxial injection of opioid as part of a regional anesthetic for cesarean delivery. These techniques have specific advantages and disadvantages.

Superior hypogastric plexus blockade (SHB) has been shown an effective method for pain relıef after gynecologic procedures, it has been shown that SHP can be easily performed intraoperatively during hysterectomy procedure In this study, we aimed to investigate the efficacy of SHB performed intraoperatively for postoperative pain relief after cesarean section. To our knowledge, this is the first study to use SHB intraoperatively for pain relief after cesarean section in the literature.

Detailed description: Cesarean section is a life-saving surgical operation performed during pregnancy and labor. It is the most common inpatient surgical procedure in the United States with 1.3 million cesarean deliveries performed in 2015. Cesarean section frequency is increasing rapidly in worldwide, especially in middle and high income countries.

Postoperative pain is an expected outcome for patients following surgical procedures. Inadequate pain relief is still a common problem among hospitalized patients. A number of surveys report that 30%-70% of surgical patients experience moderate to severe pain (Breivik) At least 10.9% of women experience severe pain within 24 h after cesarean section. An analysis of 50523 patients from 105 hospitals questioning pain intensity on the first postoperative day revealed that cesarean section ranked ninth for pain severity among 179 different surgical procedures.

In this regard, multimodal pain therapy has been suggested for postoperative pain management after cesarean delivery. It requires the use of a combination of drugs with different mechanisms of action, and aims at achieving optimal analgesia through additive or synergistic drug action with small doses of opiates and decreased side effects. The most commonly used modalities are systemic administration of opioids, either by intramuscular injection or IV by patient-controlled analgesia, and neuraxial injection of opioid as part of a regional anesthetic for cesarean delivery. These techniques have specific advantages and disadvantages.

Recently, superior hypogastric plexus blockade (SHB) has been shown an effective method for pain relıef after gynecologic procedures, i.e. hysterectomy (kaynak). The superior hypogastric plexus (SHP) is a retroperitoneal structure located bilaterally at the level of the lower third of the fifth lumbar vertebral body and upper third of the first sacral vertebral body at the sacral promontory in which it is most accessible to block for pelvic pain relief. Besides it can be performed either by fluoroscopy-guided, ultrasound (US)-guided, or CT-guided techniques, it has been shown that SHP can be easily performed intraoperatively during hysterectomy procedure ().

In this study, we aimed to investigate the efficacy of SHB performed intraoperatively for postoperative pain relief after cesarean section. To our knowledge, this is the first study to use SHB intraoperatively for pain relief after cesarean section in the literature.

Eligibility criteria: Inclusion Criteria:

* Term singleton pregnant women between ages 18 to 40 with no previous history of cesarean section or abdominal surgery were scheduled for elective cesarean operation under general anaesthesia. Only ASA 1-2 patients were included to the study.

Exclusion Criteria:

* We excluded patients with suspected or manifest bleeding disturbances, chronic pelvic pain, allergy to NSAID's or opioids, atopia, bronchial asthma, diabetes mellitus, the presence of liver or kidney diseases, abuse of drugs or alcohol, and patients with pregnancy-induced hypertension or preeclampsia. The patients underwent emergency cesarean section were also excluded from the study.

Primary outcomes:
measure: Pain scores on rest and on movement at 24 th hour after surgery
timeFrame: up to 24 hours
Secondary outcomes:
measure: Pain scores on rest and on movement at 2,6 and 48 th hour after surgery
timeFrame: Up to 48 hours
measure: Opioid or NSAID requirement after surgery
timeFrame: Up to 48 hours
measure: Return of gastrointestinal function
timeFrame: Up to 48 hours
measure: Rate of nausea and vomiting
timeFrame: Up to 48 hours
measure: length of surgery
timeFrame: Up to 1 hour
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Maltepe University Faculty of Medicine
Study officials:
affiliation: Maltepe University Faculty of Medicine
name: Berna Haliloglu Peker, Prof. Dr
role: PRINCIPAL_INVESTIGATOR
References: