Assessing Maternal Post-partum Pain With Suppositories (CRAMPS)

• ClinicalTrials.gov Identifier: NCT01271855
• Recruitment Status: Completed
• First Posted: January 7, 2011
• Results First Posted: February 6, 2018
• Last Update Posted: March 7, 2018
• Sponsor: Loyola University
• Information provided by (Responsible Party): Loyola University

Study Description

Brief Summary:

This trial will evaluate whether the routine use of belladonna/opium (B&O) suppositories improve patients' self-reported pain control in the first 24-hours after delivery.

Condition or disease	Intervention/treatment	Phase
Pain	Drug: Belladonna and opioid suppository; Drug: Glycerin Suppository	Phase 4

Detailed Description:

Childbirth is commonly regarded as one of life's most painful experiences and, like childbirth, the postpartum period can also be painful for women. Pain in the immediate postpartum period may significantly affect a woman's overall delivery experience. Pain control is especially important in this period, as women are bonding with their infant and trying to initiate breastfeeding, which may be adversely affected by poor pain management.

Postpartum pain may come from multiple sources. Women experience uterine cramping as a result of uterine involution. Depending on delivery type, women may also have incision pain following cesarean section or perineal pain resulting from episiotomy, perineal tears, or generalized genital trauma during delivery. Perineal pain is common, present in 75% of patients with intact perineum and up to 95-97% with perineal lacerations or episiotomies during the first day after delivery. Commonly employed methods of controlling postpartum pain include opioid analgesics, non-steroidal anti-inflammatories, acetaminophen, and topical analgesics. Pain medication is generally administered via oral or intravenous route. Several studies have investigated suppositories as an alternative method of improving pain following delivery. A double-blinded randomized controlled trial by Wilasrusmee et al (2008) showed naproxen suppositories to be effective for reducing perineal pain after vaginal delivery. Another study showed prophylactic rectal diclofenac to provide effective analgesia after perineal repair, maintained into second and third day postpartum, and a Cochrane Review showed NSAID suppositories to be associated with less pain 24 hours after birth.

Rectal analgesia provides a means of improving pain control through local effects on the perineum and uterus while possibly decreasing systemic absorption, which may in turn decrease systemic side effects and transmission to the newborn infant through breast milk. B&O suppositories contain two medications that could potentially decrease postpartum pain. Morphine, the principle agent in opium, binds opioid receptors and blocks ascending pain pathways. Atropine, a major active component of belladonna, blocks acetylcholine receptors, leading to smooth muscle relaxation. This quality may significantly improve pain from uterine contractions during the postpartum period. The primary aim of our study is to investigate whether belladonna and opium suppositories decrease patient-reported pain in the immediate postpartum period.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Participants will be randomized to receive either a belladonna and opioid suppository or a glycerin suppository (placebo) every eight hours after delivery during the first 24 hours after delivery using a 1:1 allocation
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: CRAMPS Trial: Controlled Randomized Trial Assessing Maternal Post-partum Pain With Suppositories
• Actual Study Start Date: July 22, 2009
• Actual Primary Completion Date: September 29, 2011
• Actual Study Completion Date: September 29, 2011

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Glycerin suppository; Women assigned to this arm receive a glycerin suppository (placebo) every 8 hours after delivery during the first 24 hours postpartum	Drug: Glycerin Suppository; A vegetable oil suppository (placebo) per rectum every 8 hours for the first 24 hours following delivery.
Experimental: Belladonna and opioid suppository; Women assigned to this arm receive a belladonna and opioid (B&O) suppository every 8 hours after delivery during the first 24 hours postpartum	Drug: Belladonna and opioid suppository; Belladonna and opioid suppository 16.2mg/30mg per rectum every 8 hours for 24 hours following delivery

Outcome Measures

Primary Outcome Measures :

1. Pain Level Twenty Four Hours After Delivery [ Time Frame: Twenty-four hours ]
   The primary outcome is pain measured at 24-hours after delivery. Patients will be asked to report a Visual Analog Scale (VAS) pain score at 24-hours after delivery. This scale ranges from 0 to 10 (0=no pain and 10=worst pain).

Secondary Outcome Measures :

1. Number of Patients Taking Additional Pain Medications [ Time Frame: Twenty-four hours ]
   Twenty-four hours after delivery, the number of participants taking additional pain medications will be recorded.
2. Patient Satisfaction [ Time Frame: Discharge ]
   Patients' satisfaction with their pain control is recorded at the time of discharge using a five point scale ranging from 1 (Not Satisfied) to 3 (Okay) to 5 (Very Satisfied).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Anticipated Vaginal or Cesarean delivery at Gottlieb Medical Center or Loyola University Medical Center
• > 34 weeks gestation at time of delivery
• > 18 years old
• No known allergy to belladonna, opium, or vegetable oil suppositories
• Able to consent and complete study documents

Exclusion Criteria:

• Chronic pain condition or on narcotic medication prior to admission
• Contraindications to B&O suppositories, including patients with glaucoma, severe hepatic, or renal disease; bronchial asthma; narcotic idiosyncrasies; respiratory depression; convulsive disorders; acute alcoholism; delirium tremens; history of hypersensitivity to any component of product.

Contacts and Locations

Locations

United States, Illinois

Loyola Univeristy Medical Center

Maywood, Illinois, United States, 60153

Gottlieb Memorial Hospital

Melrose Park, Illinois, United States, 60160

Sponsors and Collaborators

Loyola University

Investigators

• Principal Investigator: Kimberly Kenton, M.D.; Northwestern University

More Information

Publications:

Macarthur AJ, Macarthur C. Incidence, severity, and determinants of perineal pain after vaginal delivery: a prospective cohort study. Am J Obstet Gynecol. 2004 Oct;191(4):1199-204.

Wilasrusmee S, Chittachareon A, Jirasiritum S, Srisangchai P. Naproxen suppository for perineal pain after vaginal delivery. Int J Gynaecol Obstet. 2008 Jul;102(1):19-22. doi: 10.1016/j.ijgo.2008.01.015. Epub 2008 Mar 5.

Searles JA, Pring DW. Effective analgesia following perineal injury during childbirth: a placebo controlled trial of prophylactic rectal diclofenac. Br J Obstet Gynaecol. 1998 Jun;105(6):627-31.

Hedayati H, Parsons J, Crowther CA. Rectal analgesia for pain from perineal trauma following childbirth. Cochrane Database Syst Rev. 2003;(3):CD003931. Review.

Gallagher EJ, Bijur PE, Latimer C, Silver W. Reliability and validity of a visual analog scale for acute abdominal pain in the ED. Am J Emerg Med. 2002 Jul;20(4):287-90.

Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7.

DeLoach LJ, Higgins MS, Caplan AB, Stiff JL. The visual analog scale in the immediate postoperative period: intrasubject variability and correlation with a numeric scale. Anesth Analg. 1998 Jan;86(1):102-6.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Deussen AR, Ashwood P, Martis R, Stewart F, Grzeskowiak LE. Relief of pain due to uterine cramping/involution after birth. Cochrane Database Syst Rev. 2020 Oct 20;10:CD004908. doi: 10.1002/14651858.CD004908.pub3.

• Responsible Party: Loyola University
• ClinicalTrials.gov Identifier: NCT01271855
• Other Study ID Numbers: 201720
• First Posted: January 7, 2011
• Results First Posted: February 6, 2018
• Last Update Posted: March 7, 2018
• Last Verified: February 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: There is no plan to share individual participant data.

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Loyola University:

Belladonna; Opium; Suppository

Additional relevant MeSH terms:

Glycerol; Physiological Effects of Drugs; Cryoprotective Agents; Protective Agents