A Novel Analgesic Method for Postoperative Pain Relief After Cesarean Section: Intraoperative Superior Hypogastric Block

Postoperative Pain Clinical Trial

Official title:

A Novel Analgesic Method for Postoperative Pain Relief After Cesarean Section: Intraoperative Superior Hypogastric Block

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03897764
• Other study ID #: 101/5.5.2017
• Status: Completed
• Phase: Phase 4
• Start date: January 2, 2019
• Est. completion date: March 20, 2019

Study information

• Verified date: March 2019
• Source: Maltepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: March 20, 2019
• Est. primary completion date: February 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Intraoperative superior hypogastric plexus block
SHP is situated anterior to L5-S1 vertebral bodies, caudal to the bifurcation of the aorta. An injection of 20 ml of bupivacaine 2,5 mg/ml or saline 9 mg/ml was done retroperitoneally in the area.

Locations

Country	Name	City	State
Turkey	Maltepe University Faculty of Medicine	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Maltepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scores on rest and on movement at 24 th hour after surgery	Postoperative pain assessed by the 10 cm visual analogue scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable	up to 24 hours
Secondary	Pain scores on rest and on movement at 2,6 and 48 th hour after surgery	Postoperative pain assessed by the 10 cm visual analogue scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable	Up to 48 hours
Secondary	Opioid or NSAID requirement after surgery	Total opioid and NSAID requirement for postoperative pain relief after surgery were calculatedcalculated	Up to 48 hours
Secondary	Return of gastrointestinal function	First passage of flattus was noted as a sign of bowel function	Up to 48 hours
Secondary	Rate of nausea and vomiting	Rate of nausea and vomiting as a side effect of the procedure	Up to 48 hours
Secondary	length of surgery	length of cesarean section was recorded in each group	Up to 1 hour